Journal articles on the topic 'Online RCT'
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Wang, Cheng, Katie R. Mollan, Michael G. Hudgens, Joseph D. Tucker, Heping Zheng, Weiming Tang, and Li Ling. "Generalisability of an online randomised controlled trial: an empirical analysis." Journal of Epidemiology and Community Health 72, no. 2 (November 28, 2017): 173–78. http://dx.doi.org/10.1136/jech-2017-209976.
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BackgroundInvestigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China.MethodsInverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. Online RCT data and national cross-sectional study data from China were analysed to illustrate the process of quantitatively assessing generalisability. The RCT (identifier NCT02248558) randomly assigned participants to a crowdsourced or health marketing video for promotion of HIV testing. The primary outcome was self-reported HIV testing within 4 weeks, with a non-inferiority margin of −3%.ResultsIn the original online RCT analysis, the estimated difference in proportions of HIV tested between the two arms (crowdsourcing and health marketing) was 2.1% (95% CI, −5.4% to 9.7%). The hypothesis that the crowdsourced video was not inferior to the health marketing video to promote HIV testing was not demonstrated. The IPSW and G-formula estimated differences were −2.6% (95% CI, −14.2 to 8.9) and 2.7% (95% CI, −10.7 to 16.2), with both approaches also not establishing non-inferiority.ConclusionsConducting generalisability analysis of an online RCT is feasible. Examining the generalisability of online RCTs is an important step before an intervention is scaled up.Trial registration numberNCT02248558.
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Islam, Shahidul, Md Rakibul Hoque, and Md Abdullah Al Jamil. "Predictors of users’ preferences for online health services." Journal of Consumer Marketing 37, no. 2 (January 2, 2020): 215–25. http://dx.doi.org/10.1108/jcm-05-2018-2689.
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Purpose The purpose of this study is to explain predictors that discriminate users’ preferences for online health services, focusing on a downtown area in a developing country. Design/methodology/approach Drawing on rational choice theory (RCT), the authors test a model that links the frequency of online health service usage to access-activators and access-inhibitors. Multivariate analysis of variance (MANOVA) and the discriminant analysis model were used to analyze data from a sample of 215 internet users. Findings Results confirm the significance of responsiveness, user’s attitude, accessibility and perceived ease of use, indicating their discriminating role in the usage of online health services. Research limitations/implications The study demonstrates the relevance of RCT in measuring perceived online health service quality in an emerging context. Future research should consider the influence of electronic health (eHealth) literacy, norms and trustworthiness to increase the generalizability of the findings. Practical implications The findings of this study can help enhance the eHealth service quality by encouraging service providers to improve the interactivity and ease of use of their platforms, thus delivering value to both consumers and firms and improving the well-being of the society at large. Originality/value Few existing studies draw attention to access-activators and access-inhibitors to predict users’ preferences for online health services. This study shows the applicability of RCT in preparing the instrumental dimensions of online health service quality.
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Musicus, Aviva A., Sophia V. Hua, Marlene B. Schwartz, Jason P. Block, Frances K. Barg, Christina D. Economos, Karen Glanz, James W. Krieger, and Christina A. Roberto. "Messages Promoting Healthy Kids’ Meals: An Online RCT." American Journal of Preventive Medicine 60, no. 5 (May 2021): 674–83. http://dx.doi.org/10.1016/j.amepre.2020.11.012.
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Flynn, Samantha, Richard P. Hastings, Christine Burke, Simon Howes, Yona Lunsky, Jonathan A. Weiss, and Tom Bailey. "Online Mindfulness Stress Intervention for Family Carers of Children and Adults with Intellectual Disabilities: Feasibility Randomized Controlled Trial." Mindfulness 11, no. 9 (June 20, 2020): 2161–75. http://dx.doi.org/10.1007/s12671-020-01436-0.
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Abstract Objectives Family carers of people with intellectual disabilities (ID) are twice as likely as other carers to experience stress and mental ill-health, but research exploring interventions is sparse. Online mindfulness may provide an accessible, cost-effective resource. The addition of guided telephone support could help to tailor an existing intervention for this population. A feasibility randomized controlled trial (RCT) was conducted to inform the development of a definitive RCT. Methods Sixty participants were randomized to complete Be Mindful (a brief online mindfulness intervention) either with or without additional Peer Mentor support. Feasibility of recruitment, retention, intervention adherence, and acceptability of study design was examined. Preliminary analyses were undertaken on participant-reported outcomes pre- and post-intervention. Eighteen semi-structured interviews were conducted as a process evaluation. Results Feasibility outcomes indicate that it would be possible to recruit and retain (88%) participants to a definitive RCT, and that the study design and intervention are acceptable. The addition of guided telephone support was not burdensome; indeed, it was additionally motivating. Telephone support can be delivered with high fidelity, but this is inconsistent and requires further piloting. Preliminary comparison data indicate small, but non-significant, improvements for participants receiving guided telephone support relative to those who did not over time. Conclusions It is feasible to deliver online mindfulness with additional telephone-guided support to family carers of people with ID, and this may lead to small benefits over receiving online mindfulness alone. A definitive RCT can be planned to examine the effectiveness and cost-effectiveness of this intervention.
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Thorén, Elisabet Sundewall, Marie Öberg, Gerhard Andersson, and Thomas Lunner. "Internet Interventions for Hearing Loss." American Journal of Audiology 24, no. 3 (September 2015): 316–19. http://dx.doi.org/10.1044/2015_aja-15-0009.
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Purpose The purpose of the two studies presented in this research forum article was to develop audiological rehabilitation programs for experienced hearing aid users and evaluate them in online versions. In this research forum article, the differences between the two studies are discussed. Method Two randomized controlled trials (RCTs) were performed evaluating the efficacy of online rehabilitation, including professional guidance by an audiologist. In each RCT, the effects of the online programs were compared with the effects measured in a control group. Results The results from the first RCT showed a significant increase in activity and participation for both groups with participants in the intervention group improving more than those in the control group. At the 6-month follow-up, after the study, the significant increase was maintained; however, amounts of increase in the two groups were no longer significantly different. The results from the second RCT showed significant increase in activity and participation for the intervention group, although the control group did not improve. Conclusions The results from the RCTs provide evidence that the Internet can be used to deliver rehabilitation to hearing-aid users and that their problems are reduced by the intervention; however, the content of the online rehabilitation program requires further investigation.
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Webster, Britney, Alexandra Jeanblanc, Gregory Smith, and Frank Infurna. "Comparisons Between Recruitment and Retention Strategies for Two Online RCTs." Innovation in Aging 5, Supplement_1 (December 1, 2021): 82. http://dx.doi.org/10.1093/geroni/igab046.314.
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Abstract Custodial grandfamilies (CGF) comprise a small, diverse group of the US population which can make samples difficult to recruit and retain. Two online RCT studies (S1 & S2) for CGF used a variety of recruitment strategies with varying success. S1, for grandmothers (GM) only, successfully recruited from Facebook (47.95%) and community flyers (17.73%). S2, dyadic study for GM and adolescent grandchildren (AGC), recruited through emails to high school counselors (43.29%) and community (30.94%) and professional (17.13%) kinship support organizations. The advantages of online RCTs for hard-to-reach populations include expedited administration, buffering against social distancing, nationwide enrollment (S1-42 states; S2-43 states), and generalizability of findings. Challenges of online RCTs are establishing rapport and building trust with participants who are not comfortable with technology and designing screenings to identify false participants. Overall, these studies highlight the advantages of an online RCT, especially for hard-to-reach populations like custodial grandfamilies.
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Caspar, Franz. "Case Studies of Clinician-Guided, Online Therapy: Towards a Fuller Understanding of How and Under What Conditions Such Therapy Works." Pragmatic Case Studies in Psychotherapy 13, no. 3 (November 12, 2017): 265. http://dx.doi.org/10.14713/pcsp.v13i3.2014.
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Ciuca, Berger, and Miclea (2017) and Schulz, Vincent, & Berger (2017) each present a pair of process-focused, systematic case studies, one with good outcome and one with a poorer outcome. These cases were drawn from a randomized controlled trial (RCT) of an Online self-help therapy for panic disorder and social anxiety disorder, respectively. In both instances the cases were drawn from the clinician-guided arm of the RCT. This commentary reviews the kind of knowledge emerging from these pairs of case studies from a variety of perspectives, including: the practical advantages of online, clinician-guided treatment; client readiness for treatment; the role of the therapist alliance; the broad reach of online therapy; and the important complementary role that systematic case studies play in enhancing the knowledge that emerges from RCTs.
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Kallestad, Håvard, Øystein Vedaa, Jan Scott, Gunnar Morken, Ståle Pallesen, Allison G. Harvey, Phil Gehrman, et al. "Overcoming insomnia: protocol for a large-scale randomised controlled trial of online cognitive behaviour therapy for insomnia compared with online patient education about sleep." BMJ Open 8, no. 8 (August 2018): e025152. http://dx.doi.org/10.1136/bmjopen-2018-025152.
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IntroductionInsomnia is a major public health concern. While cognitive behaviour therapy for insomnia (CBT-I) is acknowledged as the best available intervention, there are unanswered questions about its wider dissemination, socioeconomic benefits and its impact on health resource utilisation. The aim of this randomised controlled trial (RCT) is to investigate the effectiveness of a fully automated online version of CBT-I compared with online patient education about sleep (PE). Outcome measures comprise changes in symptoms of insomnia, time off work due to sick leave as well as medication and health resource utilisation. Also, we will examine (i) putative mediators of the effects of CBT-I on insomnia severity and (ii) selected potential psycho-bio-social moderators of the effects of the interventions.Methods and analysisA parallel-group RCT will be conducted in a target sample of about 1500 adults recruited across Norway. Participants will complete an online screening and consent process. Those who meet eligibility criteria will be randomised to receive direct access to fully automated online CBT-I or to an online PE programme. The primary outcome is change in insomnia severity immediately postintervention; secondary outcomes are change in daytime functioning and other sleep measures postintervention and at 6-month and 24-month follow-up. Objective data from national registries will be obtained at two time points (1 year and 2 years post-treatment), allowing a mirror image study of preintervention and postintervention rates of sick leave, and of medication and healthcare utilisation by condition.Ethics and disseminationThe study protocol was approved by the Regional Committee for Medical and Health Research Ethics in South East Norway (2015/134). Findings from the RCT will be disseminated in peer-reviewed publications and conference presentations. Exploratory analyses of potential mediators and moderators will be reported separately. User-friendly outputs will be disseminated to patient advocacy and other relevant organisations.Trial registration numberNCT02558647; Pre-results.
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Delaney, Tessa, Luke Wolfenden, Sze Lin Yoong, Rachel Sutherland, John Wiggers, Kylie Ball, Karen Campbell, and Chris Rissel. "Improving healthy food purchases from online canteens: A cluster RCT." Obesity Research & Clinical Practice 13, no. 3 (May 2019): 269. http://dx.doi.org/10.1016/j.orcp.2018.11.096.
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Wu, Manli, Xiaojuan Xu, Lele Kang, J. Leon Zhao, and Liang Liang. "Encouraging people to embrace feedback-seeking in online learning." Internet Research 29, no. 4 (August 5, 2019): 749–71. http://dx.doi.org/10.1108/intr-04-2017-0162.
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Purpose The purpose of this paper is to examine the impacts of perceived informational value and perceived relational value on feedback-seeking intention in online communities of inquiry (OCoIs). To develop an integrated theoretical framework, the antecedents of perceived informational value and perceived relational value are also investigated. Design/methodology/approach This study builds on the relational communication theory (RCT) and the social psychology perspective to develop an integrated research model regarding feedback-seeking. Hypotheses were empirically tested using data collected from 262 subjects who are members of OCoIs. Findings The results indicate that feedback-seeking intention is positively affected by perceived informational and relational value of feedback-seeking. Furthermore, perceived informational value partially mediates the effects of feedback-seeking self-efficacy and learning goal orientation on feedback-seeking intention; perceived relational value partially mediates the effects of social influence and social risk on feedback-seeking intention. Practical implications The results suggest that practitioners can promote feedback-seeking by enhancing learners’ informational and relational dependencies on OCoIs. To achieve effective online learning, practitioners should consider learners’ characteristics to provide personalized learning interventions. Originality/value This study advances RCT and the social psychology perspective to develop an integrated model for understanding feedback-seeking. The empirical results complement information-related explanations of feedback-seeking by finding that a relationship-related explanation is more important for promoting feedback-seeking in OCoIs. The proposed model also indicates that tolerance for ambiguity serves as a moderator in the relationship between perceived informational value and its antecedents.
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Beutel, M. E., J. Becker, K. Hagen, M. Siepmann, R. J. Knickenberg, and R. Zwerenz. "Does blended online care improve outcomes of inpatient psychotherapy? An RCT with an additional online self-help program." Journal of Psychosomatic Research 109 (June 2018): 91–92. http://dx.doi.org/10.1016/j.jpsychores.2018.03.027.
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Bailey, Julia V., Rosie Webster, Rachael Hunter, Mark Griffin, Nicholas Freemantle, Greta Rait, Claudia Estcourt, et al. "The Men’s Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men." Health Technology Assessment 20, no. 91 (December 2016): 1–124. http://dx.doi.org/10.3310/hta20910.
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BackgroundThis report details the development of the Men’s Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation.Objectives(1) Develop the Men’s Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men’s views of online research methodology.Methods(1) Website development: we combined evidence from research literature and the views of experts (n = 18) and male clinic users (n = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men’s Safer Sex website plus usual care (n = 84) or usual clinic care only (n = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires.Results(1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men’s Safer Sex website and technical problems were frustrating. Men’s views of the Men’s Safer Sex website and research procedures were largely positive.ConclusionsIt would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS.Trial registrationCurrent Controlled Trials ISRCTN18649610.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.
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Fagroud, Fatima Zahra, El Habib Ben Lahmar, Hicham Toumi, Youssef Baddi, and Sanaa El Filali. "RT-RCT: an online tool for real-time retrieval of connected things." Bulletin of Electrical Engineering and Informatics 10, no. 5 (October 1, 2021): 2804–10. http://dx.doi.org/10.11591/eei.v10i5.2901.
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In recent years, internet of things (IoT) represents a giant and a promoter area in innovation and engineering fields. IoT devices are spread in various fields and offer advanced services which assist their users to monitor and control objects remotely. IoT has a set of special characteristics such as dynamic, variety of data and huge scale which introduces a great challenge in the field of retrieval technologies, more precisely real-time retrieval. This paper addresses the issue of real-time retrieval of connected things and tries to propose an innovative solution which allows the retrieval of these things and their descriptive data. The paper proposes an on-line tool for real-time retrieval of connected things and their descriptive data based on network port scanning technique. The performance of this tool proves to be powerful under normal conditions, however more tests must be implemented in the aim to improve the proposed solution. The tool resulted from this work appears to be promising and can be used as a reference by network administrators and IT security managers for the development of new security mechanisms and security reinforcement.
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West, Delia S., Rebecca A. Krukowski, Eric A. Finkelstein, Melissa L. Stansbury, Doris E. Ogden, Courtney M. Monroe, Chelsea A. Carpenter, Shelly Naud, and Jean R. Harvey. "Adding Financial Incentives to Online Group-Based Behavioral Weight Control: An RCT." American Journal of Preventive Medicine 59, no. 2 (August 2020): 237–46. http://dx.doi.org/10.1016/j.amepre.2020.03.015.
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Conrad, Jonas, Jan Retelsdorf, Sameh Attia, Christof Dörfer, and Mohamed Mekhemar. "German Dentists’ Preferences for the Treatment of Apical Periodontitis: A Cross-Sectional Survey." International Journal of Environmental Research and Public Health 17, no. 20 (October 13, 2020): 7447. http://dx.doi.org/10.3390/ijerph17207447.
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Currently, there is no standard treatment protocol for apical periodontitis (AP). Thus, restorable teeth might get extracted and replaced prosthetically. This study evaluated German dentists’ preferred AP treatment decisions and the influencing factors for selecting tooth retention by initial/repeated surgical/non-surgical root-canal treatment (RCT) or extraction with/without prosthetic replacement. Through an online-survey, participants (n = 260) rated different treatment options for four case scenarios with AP in anterior/posterior teeth without/with previous RCT. Statistical analysis included the Friedman test for intra-case comparisons and Chi-squared test for factor-associations (p ≤ 0.05). Tooth retention using initial/repeated RCT was ranked first in all scenarios and rated as (very) appropriate by most participants, while implant-supported crowns (ISC) and apicoectomy had the second ratings. ISC were preferred more on posterior teeth or previous root-canal-treated teeth. Rating levels of treatment options displayed significant differences for all case scenarios. Posterior tooth retention by RCT demonstrated a significant association with work experience. Tooth retention with previous RCT displayed a significant correlation with dentists’ privately insured patients. Most dentists preferred tooth preserving with initial/repeated RCT, while others selected non-evidence-based choices. This reflects a lack of consensus of AP treatment decisions in Germany. Fixed treatment guidelines and further evaluation of treatment–decision-correlated factors are recommended for correct treatment planning.
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Williams, Christopher, Carrie-Anne McClay, Rebeca Martinez, Jill Morrison, Caroline Haig, Ray Jones, and Paul Farrand. "Online Cognitive Behavioral Therapy (CBT) Life Skills Program for Depression: Pilot Randomized Controlled Trial." JMIR Formative Research 6, no. 2 (February 17, 2022): e30489. http://dx.doi.org/10.2196/30489.
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Background Depression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioral therapy (CBT) is an effective treatment for depression and anxiety when delivered one-to-one by an expert practitioner, but access to this talking therapy is often limited, and waiting lists can be long. However, a range of low-intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes, and online packages. Objective This project aimed to pilot a randomized controlled trial (RCT) of an online CBT-based life skills course with community-based individuals experiencing depression. Methods Individuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomized to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by nonspecialist, charity-based workers while they used the online intervention. The primary end point was at 3 months postrandomization, at which point, the DA group were offered the intervention. Levels of depression, anxiety, social functioning, and satisfaction were assessed. Results There were effective recruitment, randomization, and uptake, with 19 IA and 17 DA control participants entering the pilot study via newspaper advertisements and 13 of the 19 participants taking up the intervention. Overall, 72% (26/36) were not currently under the care of their general practitioner. The online package was acceptable to participants; the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (SD 8.89). At 3 months, data collection was achieved from 78% (28/36) of the participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT. Conclusions The research design successfully tested the recruitment, data collection, and intervention delivery. The pilot study has provided data for the required sample size for the full RCT. Trial Registration ISRCTN registry ISRCTN12890709; https://doi.org/10.1186/ISRCTN12890709 International Registered Report Identifier (IRRID) RR2-10.1186/s13063-016-1336-y
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Rockette-Wagner, Bonny, Gary S. Fischer, Andrea M. Kriska, Molly B. Conroy, David Dunstan, Caroline Roumpz, and Kathleen M. McTigue. "Efficacy of an Online Physical Activity Intervention Coordinated With Routine Clinical Care: Protocol for a Pilot Randomized Controlled Trial." JMIR Research Protocols 9, no. 11 (November 3, 2020): e18891. http://dx.doi.org/10.2196/18891.
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Background Most adults are not achieving recommended levels of physical activity (150 minutes/week, moderate-to-vigorous intensity). Inadequate activity levels are associated with numerous poor health outcomes, and clinical recommendations endorse physical activity in the front-line treatment of obesity, diabetes, dyslipidemia, and hypertension. A framework for physical activity prescription and referral has been developed, but has not been widely implemented. This may be due, in part, to the lack of feasible and effective physical activity intervention programs designed to coordinate with clinical care delivery. Objective This manuscript describes the protocol for a pilot randomized controlled trial (RCT) that tests the efficacy of a 13-week online intervention for increasing physical activity in adult primary care patients (aged 21-70 years) reporting inadequate activity levels. The feasibility of implementing specific components of a physical activity clinical referral program, including screening for low activity levels and reporting patient program success to referring physicians, will also be examined. Analyses will include participant perspectives on maintaining physical activity. Methods This pilot study includes a 3-month wait-listed control RCT (1:1 ratio within age strata 21-54 and 55-70 years). After the RCT primary end point at 3 months, wait-listed participants are offered the full intervention and all participants are followed to 6 months after starting the intervention program. Primary RCT outcomes include differences across randomized groups in average step count, moderate-to-vigorous physical activity, and sedentary behavior (minutes/day) derived from accelerometers. Maintenance of physical activity changes will be examined for all participants at 6 months after the intervention start. Results Recruitment took place between October 2018 and May 2019 (79 participants were randomized). Data collection was completed in February 2020. Primary data analyses are ongoing. Conclusions The results of this study will inform the development of a clinical referral program for physical activity improvement that combines an online intervention with clinical screening for low activity levels, support for postintervention behavior maintenance, and feedback to the referring physician. Trial Registration ClinicalTrials.gov NCT03695016; https://clinicaltrials.gov/ct2/show/NCT03695016. International Registered Report Identifier (IRRID) DERR1-10.2196/18891
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Alwadani, Mohammad, Mohammed H. Mashyakhy, Amr Jali, Arwa O. Hakami, Ahmed Areshi, Abdlelah A. Daghriri, Fawzia I. Shaabi, and Mohammed M. Al Moaleem. "Dentists and Dental Intern’s Preferences of Root Canal Treatment with Restoration Versus Extraction then Implant-Supported Crown Treatment Plan." Open Dentistry Journal 13, no. 1 (February 28, 2019): 93–100. http://dx.doi.org/10.2174/1874210601913010093.
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Objectives: The intent of this study was to evaluate and compare the preferences and treatment choices between dentists and dental interns with regard to the following different treatment modalities: Root Canal Treatment (RCT) with restoration versus extraction with Implant-Supported Crown (ISC) or surgical treatment in relation to the given case scenarios. Methods: The questionnaire was presented as an online survey with a case scenario. The total number of the respondents were 165. The four clinical case scenarios included an anterior and posterior tooth having apical periodontitis, with and without previous RCT. The treatment options were as follows: RCT with restoration, extraction then implant, and surgical treatment. Results: A total of 165 dentists and dental interns were included in this study. A hundred and three 62.4% respondents were dentists, 60; 36.3% were males and 105; 63.7% were females. Most of the respondents graduated from the College of Dentistry, Jazan University (93.9%). The highest percentages and numbers for Anterior Teeth (AT) were selected in related to the RCT and restorations in the four scenarios among gender, dentists, and interns, with no considerable differences. A high percentage of RCT and restoration option was recorded for Posterior Teeth (PT) with no previous restoration and around 50% for the same treatment modality to posterior teeth with previous restorations. For Future Planning Postgraduate Studies (FPPS), it was obvious that most of the selected specialties agreed with the RCT and restorations choice. Conclusion: All dentists and interns in both genders preferred RCT with restorations over extraction, and then ISC in the AT with and without previous RCTs. In the PT with no previous RCT, the participants agreed that RCT with restorations is superior to other choices. Among the FPPS, the respondents demonstrated an absolute agreement to RCT and restorations as a treatment of choice for different scenarios. Clinical Significance: Dentists should preserve the natural teeth by RCT with restoration as the first treatment choice followed by other choices. The nonsurgical approach should always be adopted as a routine measure in PA lesions of endodontic origin. Conservative orthograde endodontic therapy demonstrates favorable outcomes with a regular periodic review and assessment of the healing process of PA lesions.
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Murphy, Mairead, Anne Scott, Geoff Wong, Scott Walter, Jude Hancock, Tom Palmer, and Chris Salisbury. "The consultation open and close study: A feasibility study of a complex intervention." NIHR Open Research 2 (April 14, 2022): 29. http://dx.doi.org/10.3310/nihropenres.13267.1.
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Background: Use of telephone, video and online consultations in general practice is increasing. This can lead to transactional consultations which make it harder for patients to describe how symptoms affect their lives, and confusion about plans for future care. The aim of this study was to test the feasibility of a randomised control trial (RCT) for a complex intervention designed to address patients’ concerns more comprehensively and help them remember advice from general practitioners (GPs). Methods: The complex intervention used two technologies: a patient-completed pre-consultation form at consultation opening and a doctor-provided summary report printed or texted at consultation closure. The feasibility of the intervention was tested in a cluster-randomised framework in six practices: four randomised to intervention, and two to control. Thirty patients were recruited per practice. Quantitative data was collected via patient-reported questionnaires and health records. GPs, patients and administrators were interviewed. Analysis included a process evaluation, recruitment and follow-up rates, and data completeness to assess feasibility of a future RCT. Results: The intervention was acceptable and useful to patients and GPs, but the process for the pre-consultation form required too much support from the researchers for a trial to be feasible. Both technologies were useful for different types of patients. Recruitment rates were high (n=194) but so was attrition, therefore criteria to progress to an RCT were not met. Conclusions: Both the pre-consultation form and the summary report showed important potential benefits. They should be considered as separate interventions and evaluated independently. The technology to send pre-consultation forms needs further development to allow integration with GP computer systems. The additional time needed to generate summary reports meant GPs preferred to use it selectively. Collecting outcome data using online questionnaires was efficient but associated with high attrition, so alternative approaches are needed before a full RCT is feasible.
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Toupin April, Karine, Jennifer Stinson, Sabrina Cavallo, Laurie Proulx, George A. Wells, Ciarán M. Duffy, Tania ElHindi, Patricia E. Longmuir, and Lucie Brosseau. "Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial." JMIR Research Protocols 9, no. 7 (July 6, 2020): e12823. http://dx.doi.org/10.2196/12823.
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Background Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children. According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions. Objective The primary aims of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA: a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group; and (2) the acceptability of these interventions. Methods A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A: n=10); (2) online aerobic dance training program (group B: n=10); and (3) electronic pamphlet control group (group C: n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a videoconferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the videoconferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline and then weekly until the end of the 12-week program. Results This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children’s Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started. Conclusions To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT. International Registered Report Identifier (IRRID) PRR1-10.2196/12823
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Newman, Peter A., Venkatesan Chakrapani, Charmaine Williams, Notisha Massaquoi, Suchon Tepjan, Surachet Roungprakhon, Pakorn Akkakanjanasupar, Carmen Logie, and Shruta Rawat. "An eHealth Intervention for Promoting COVID-19 Knowledge and Protective Behaviors and Reducing Pandemic Distress Among Sexual and Gender Minorities: Protocol for a Randomized Controlled Trial (#SafeHandsSafeHearts)." JMIR Research Protocols 10, no. 12 (December 10, 2021): e34381. http://dx.doi.org/10.2196/34381.
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Background Existing data on COVID-19 disparities among vulnerable populations portend excess risk for lesbian, gay, bisexual, transgender (LGBT) and other persons outside of heteronormative and cisgender identities (ie, LGBT+). Owing to adverse social determinants of health, including pervasive HIV and sexual stigma, harassment, violence, barriers in access to health care, and existing health and mental health disparities, sexual and gender minorities in India and Thailand are at disproportionate risk for SARS-CoV-2 infection and severe disease. Despite global health disparities among LGBT+ populations, there is a lack of coordinated, community-engaged interventions to address the expected excess burden of COVID-19 and public health–recommended protective measures. Objective We will implement a randomized controlled trial (RCT) to evaluate the effectiveness of a brief, peer-delivered eHealth intervention to increase COVID-19 knowledge and public health–recommended protective behaviors, and reduce psychological distress among LGBT+ people residing in Bangkok, Thailand, and Mumbai, India. Subsequent to the RCT, we will conduct exit interviews with purposively sampled subgroups, including those with no intervention effect. Methods SafeHandsSafeHearts is a 2-site, parallel waitlist-controlled RCT to test the efficacy of a 3-session, peer counselor–delivered eHealth intervention based on motivational interviewing and psychoeducation. The study methods, online infrastructure, and content were pilot-tested with LGBT+ individuals in Toronto, Canada, before adaptation and rollout in the other contexts. The primary outcomes are COVID-19 knowledge (index based on US Centers for Disease Control and Prevention [CDC] items), protective behaviors (index based on World Health Organization and US CDC guidelines), depression (Patient Health Questionnaire-2), and anxiety (Generalized Anxiety Disorder-2). Secondary outcomes include loneliness, COVID-19 stress, and intended care-seeking. We will enroll 310 participants in each city aged 18 years and older. One-third of the participants will be cisgender gay, bisexual, and other men who have sex with men; one-third will be cisgender lesbian, bisexual, and other women who have sex with women; and one-third will be transfeminine, transmasculine, and gender nonbinary people. Participants will be equally stratified in the immediate intervention and waitlist control groups. Participants are mainly recruited from online social media accounts of community-based partner organizations. They can access the intervention on a computer, tablet, or mobile phone. SafeHandsSafeHearts involves 3 sessions delivered weekly over 3 successive weeks. Exit interviews will be conducted online with 3 subgroups (n=12 per group, n=36 in each city) of purposively selected participants to be informed by RCT outcomes and focal populations of concern. Results The RCT was funded in 2020. The trials started recruitment as of August 1, 2021, and all RCT data collection will likely be completed by January 31, 2022. Conclusions The SafeHandsSafeHearts RCT will provide evidence about the effectiveness of a brief, peer-delivered eHealth intervention developed for LGBT+ populations amid the COVID-19 pandemic. If the intervention proves effective, it will provide a basis for future scale-up in India and Thailand, and other low- and middle-income countries. Trial Registration ClinicalTrials.gov NCT04870723; https://clinicaltrials.gov/ct2/show/NCT04870723 International Registered Report Identifier (IRRID) DERR1-10.2196/34381
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Dolbin-MacNab, Megan, Gregory Smith, Frank Infurna, Britney Webster, Luxin Hu, Saul Castro, Max Crowley, and Carol Musil. "IMPACT OF AN ONLINE SOCIAL INTELLIGENCE TRAINING PROGRAM ON CUSTODIAL GRANDMOTHERS’ WELL-BEING." Innovation in Aging 6, Supplement_1 (November 1, 2022): 294. http://dx.doi.org/10.1093/geroni/igac059.1166.
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Abstract Despite widespread evidence that the circumstances leading to care, combined with the stress of full-time parenting, have profound effects on psychological, physical, and social functioning of custodial grandmothers (CGM) and their adolescent grandchildren (GC), evidence-based interventions for these families are scarce. To address this gap, we conducted a randomized clinical trial (RCT) with 349 nationally recruited CGMs which compared an online social intelligence training intervention (SIT; n=185) to an attention-control (AC; n=164) condition. The SIT focused on enhancing CGMs’ capacity to develop and sustain positive social ties; an important goal since working models of attachment and caregiving are challenged and re-shaped by the off-time and demanding nature of parenting a GC. To investigate initial impact of SIT, we conducted multi-domain latent difference score models (Mplus 8) on a full intent-to-treat basis comparing the two RCT conditions on changes across key outcomes from baseline to immediate post-intervention. In comparison to AC, SIT yielded statistically significant improvement in CGMs’ depressed affect, self-esteem, relationship quality with the GC, and attachment avoidance and attachment anxiety with GC. Contrary to expectations, no significant differences were found between the two conditions on outcomes indicative of social competence (e.g., perspective taking, social awareness, social information processing, social self-monitoring). We conclude that CGMs may have applied information obtained from the SIT primarily to their relationship with GC. Our findings point to the potential benefits of the self-guided SIT, given that it can be delivered online and therefore has widespread reach to a vulnerable population. [Funded by R01AG054571]
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Yom-Tov, Elad, Anat Brunstein-Klomek, Or Mandel, Arie Hadas, and Silvana Fennig. "Inducing Behavioral Change in Seekers of Pro-Anorexia Content Using Internet Advertisements: Randomized Controlled Trial." JMIR Mental Health 5, no. 1 (February 22, 2018): e6. http://dx.doi.org/10.2196/mental.8212.
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Background The influence of pro-anorexia (pro-ana) websites is debated, with studies indicating both negative and positive effects, as well as significant variation in the effects of different websites for those suffering from eating disorders (EDs) and the general population. Online advertising, known to induce behavioral change both online and in the physical world, has not been used so far to modify the search behavior of people seeking pro-ana content. Objective The objective of this randomized controlled trial (RCT) was to examine if online advertisements (ads) can change online search behaviors of users who are looking for online pro-ana content. Methods Using the Bing Ads system, we conducted an RCT to randomly expose the searchers for pro-ana content to 10 different ads referring people to one of the three websites: the National Eating Disorders Association, the National Institutes of Mental Health, and MyProAna. MyProAna is a pro-ana website that was found in a previous study to be associated with less pathological online behaviors than other pro-ana websites. We followed participants exposed and unexposed to the ads to explore their past and future online searches. The ads were shown 25,554 times and clicked on 217 times. Results Exposure to the ads was associated with a decrease in searches for pro-ana and self-harm content. Reductions were greatest among those referred to MyProAna (reduction of 34.0% [73/215] and 37.2% [80/215] for pro-ana and self-harm, respectively) compared with users who were referred elsewhere (reduction of 15.47% [410/2650] and 3.21% [85/2650], respectively), and with users who were not shown the ads, who increased their behaviors (increase of 57.12% [6462/11,314] and 4.07% [461/11,314], respectively). In addition, those referred to MyProAna increased their search for treatment, as did control users, who did so to a lesser extent. However, users referred elsewhere decreased their searches for this content. Conclusions We found that referring users interested in ED-related content to specific pro-ana communities might lessen their maladaptive online search behavior. This suggests that those who are preoccupied with EDs can be redirected to less pathological online searches through appropriate pathways. Trial Registration ClinicalTrials.gov NCT03439553; https://clinicaltrials.gov/show/NCT03439553 (Archived by WebCite at http://www.webcitation.org/6xNYnxYlw)
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Khalifeh, Hind, Emma Molyneaux, Ruth Brauer, Simone Vigod, and Louise M. Howard. "Patient decision aids for antidepressant use in pregnancy: a pilot randomised controlled trial in the UK." BJGP Open 3, no. 4 (December 2019): bjgpopen19X101666. http://dx.doi.org/10.3399/bjgpopen19x101666.
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BackgroundDecision-making regarding antidepressant use in pregnancy is challenging, given the uncertain evidence base on the benefits and risks for women and their children. Patient decision aids (PDAs) can improve shared decision-making for complex health decisions but no evidence-based PDAs exist for antidepressant use in pregnancy.AimTo assess the feasibility of a full-scale randomised controlled trial (RCT) to evaluate the efficacy of an electronic PDA on antidepressant use in pregnancy.Design & settingA UK-based pilot parallel-group RCT.MethodThe study recruited women whose clinicians recommended an antidepressant for depression in a current or planned pregnancy, and who were uncertain about antidepressant use while pregnant. Women were recruited via clinician or self-referral, and randomised to online access to the PDA or online access to standard resource list, with primary follow-up at 4 weeks and longer-term follow-up. The primary outcome was protocol feasibility (recruitment target of 50 women and follow-up rate of 80%). Outcome measures for a future full-scale RCT included the decisional conflict scale (DCS).ResultsFifty-one women were recruited with a follow-up rate of 90.2% at 4 weeks. The PDA received good overall satisfaction ratings (mean 4.2/5). Analysis of covariance (ANCOVA) indicated a small improvement in decisional conflict at 4 weeks, accounting for baseline scores (DCS regression coefficient = -3.5, 95% confidence intervals [CI = -12.6 to 5.6]).ConclusionThis pilot RCT for an electronic PDA on antidepressant use in pregnancy showed that the study protocol was feasible, with high rates of participant satisfaction among those randomised to the PDA.
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Kallestad, Håvard, Simen Saksvik, Øystein Vedaa, Knut Langsrud, Gunnar Morken, Stian Lydersen, Melanie R. Simpson, et al. "Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial." BMJ Open 11, no. 6 (June 2021): e050661. http://dx.doi.org/10.1136/bmjopen-2021-050661.
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IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.
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Coletta, Giulia, Angelica McQuarrie, Julia Delvecchio, Paula Bochnak, Meridith Griffin, Ada Tang, and Stuart Phillips. "A LIVE ONLINE EXERCISE PROGRAM FOR OLDER ADULTS’ IMPROVED DEPRESSIVE SYMPTOMS: A PILOT RCT." Innovation in Aging 6, Supplement_1 (November 1, 2022): 246–47. http://dx.doi.org/10.1093/geroni/igac059.979.
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Abstract Exercise improves mental health and effectively alleviates cognitive and physical declines. Unfortunately, engagement in physical activity decreases as individuals age and this was likely exacerbated by the COVID-19 pandemic. New technologies to deliver live online home-based group exercise classes may help mitigate mental and physical health declines in older adults while maintaining social connectivity. We evaluated the feasibility of an age-appropriate and ability-modified at-home exercise program via live video stream. The impact on loneliness, anxiety, and depression in older adults were exploratory outcomes. In this two-arm pilot RCT, we randomly assigned sedentary community-dwelling adults (65-80 years) to a waitlist control (CON) or an active group (ACTIVE) of thrice-weekly, 8-wk online live exercise program delivered via Zoom by trained exercise professionals. Attendance was recorded, and participant satisfaction to ACTIVE was assessed. Pre- and post-intervention loneliness, anxiety, and depression were collected using the revised UCLA Loneliness Scale (R-UCLA), the Geriatric Anxiety Inventory (GAI), and the Geriatric Depression Scale (GDS). 32 participants were randomized (ACTIVE: n=16, mean age 70 ± 4, 69% women, 30 ± 5 kg/m2; CON: n=16, mean age 71 ± 5; 88% women; 29 ± 5 kg/m2). Attendance to online classes was >80% and all ACTIVE participants reported being satisfied with the exercise sessions. There was no intervention effect compared to CON on loneliness and anxiety. An effect of the intervention was observed for depression (ACTIVE: -1.94; CON: -0.07; p=0.015). We demonstrated good feasibility, satisfaction, and preliminary efficacy of a live online exercise program on older adults’ mental health.
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Anderson, Anna M., Elizabeth C. Lavender, Esther Dusabe-Richards, Teumzghi F. Mebrahtu, Linda McGowan, Philip G. Conaghan, Sarah R. Kingsbury, Gerry Richardson, Deborah Antcliff, and Gretl A. McHugh. "Peer mentorship to improve self-management of hip and knee osteoarthritis: a randomised feasibility trial." BMJ Open 11, no. 7 (July 2021): e045389. http://dx.doi.org/10.1136/bmjopen-2020-045389.
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ObjectiveTo determine the feasibility of conducting a randomised controlled trial (RCT) of a peer mentorship intervention to improve self-management of osteoarthritis (OA).DesignSix-month parallel group non-blinded randomised feasibility trial.SettingOne secondary care and one primary care UK National Health Service Trust.ParticipantsFifty adults aged ≥55 years old with hip and/or knee OA.InterventionsParticipants were allocated 1:1 to the intervention or control group using an online randomisation service. Intervention group participants received usual care (information resources) and up to eight community-based self-management support sessions delivered by a peer mentor (trained volunteer with hip and/or knee OA). Control group participants received usual care only.Outcome measuresKey feasibility outcomes were participant and peer mentor recruitment and attrition, intervention completion and the sample size required for a definitive RCT. Based on these feasibility outcomes, four success criteria for proceeding to a definitive RCT were prespecified. Patient-reported outcomes were collected via questionnaires at baseline, 8 weeks and 6 months.ResultsNinety-six individuals were screened, 65 were eligible and 50 were randomised (25 per group). Of the 24 participants who commenced the intervention, 20 completed it. Four participants did not complete the 6-month questionnaire. Twenty-one individuals were eligible for the peer mentor role, 15 were trained and 5 withdrew prior to being matched with a participant. No intervention-related harms occurred. Allowing for 20% attrition, the sample size required for a definitive RCT was calculated as 170 participants. The intervention group showed improvements in self-management compared with the control group.ConclusionsThe feasibility outcomes achieved the prespecified criteria for proceeding to an RCT. The exploratory analyses suggest peer mentorship may improve OA self-management. An RCT of the OA peer mentorship intervention is therefore warranted with minor modifications to the intervention and trial procedures.Trial registration numberISRCTN:50675542.
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Wang-Schweig, Meme, Brenda A. Miller, David B. Buller, Hilary F. Byrnes, Beth Bourdeau, and Veronica Rogers. "Using Panel Vendors for Recruitment Into a Web-Based Family Prevention Program: Methodological Considerations." Evaluation & the Health Professions 42, no. 1 (November 26, 2017): 24–40. http://dx.doi.org/10.1177/0163278717742189.
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Use of online panel vendors in research has grown over the past decade. Panel vendors are organizations that recruit participants into a panel to take part in web-based surveys and match panelists to a target audience for data collection. We used two panel vendors to recruit families ( N = 411) with a 16- to 17-year-old teen to participate in a randomized control trial (RCT) of an online family-based program to prevent underage drinking and risky sexual behaviors. Our article addresses the following research questions: (1) How well do panel vendors provide a sample of families who meet our inclusion criteria to participate in a RCT? (2) How well do panel vendors provide a sample of families who reflect the characteristics of the general population? and (3) Does the choice of vendor influence the characteristics of families that we engage in research? Despite the screening techniques used by the panel vendors to identify families who met our inclusion criteria, 23.8% were found ineligible when research staff verified their eligibility by direct telephone contact. Compared to the general U.S. population, our sample had more Whites and more families with higher education levels. Finally, across the two panel vendors, there were no significant differences in the characteristics of families, except for mean age. The online environment provides opportunities for new methods to recruit participants in research studies. However, innovative recruitment methods need careful study to ensure the quality of their samples.
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Galante, Julieta, Marie-Jet Bekkers, Clive Mitchell, and John Gallacher. "Loving-Kindness Meditation Effects on Well-Being and Altruism: A Mixed-Methods Online RCT." Applied Psychology: Health and Well-Being 8, no. 3 (June 23, 2016): 322–50. http://dx.doi.org/10.1111/aphw.12074.
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Tay, Jing Ling, Yong-Shian Shawn Goh, and Piyanee Klainin‐Yobas. "Online HOPE intervention on mental health literacy among youths in Singapore: An RCT protocol." Journal of Advanced Nursing 76, no. 7 (May 4, 2020): 1831–39. http://dx.doi.org/10.1111/jan.14393.
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Vincent, Norah, and Samantha Lewycky. "Logging on for Better Sleep: RCT of the Effectiveness of Online Treatment for Insomnia." Sleep 32, no. 6 (June 2009): 807–15. http://dx.doi.org/10.1093/sleep/32.6.807.
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Carrier, Marie-Eve, Linda Kwakkenbos, Isabelle Boutron, Joep Welling, Maureen Sauve, Cornelia van den Ende, Anne A. Schouffoer, Marie Hudson, Brett D. Thombs, and Luc Mouthon. "Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND): Study protocol." Journal of Scleroderma and Related Disorders 3, no. 1 (October 16, 2017): 91–97. http://dx.doi.org/10.5301/jsrd.5000263.
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Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale ≥3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.
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Holmes-Truscott, Elizabeth, Edith E. Holloway, Hanafi M. Husin, John Furler, Virginia Hagger, Timothy C. Skinner, and Jane Speight. "Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes: study protocol for a two-armed randomised controlled trial of ‘Is insulin right for me?’." BMJ Open 12, no. 2 (February 2022): e051524. http://dx.doi.org/10.1136/bmjopen-2021-051524.
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IntroductionPsychological barriers to insulin therapy are associated with the delay of clinically indicated treatment intensification for people with type 2 diabetes (T2D), yet few evidence-based interventions exist to address these barriers. We describe the protocol for a randomised controlled trial (RCT) examining the efficacy of a novel, theoretically grounded, psychoeducational, web-based resource designed to reduce psychological barriers to insulin among adults with non-insulin treated T2D: ‘Is insulin right for me?’.Methods and analysisDouble-blind, parallel group RCT. A target sample of N=392 participants (n=196/arm) will be randomised (1:1) to ‘Is insulin right for me?’ (intervention) or widely available online resources (control). Eligible participants include adults (18–75 years), residing in Australia, currently taking oral hypoglycaemic agents to manage T2D. They will be primarily recruited via invitations and reminders from the national diabetes registry (from a purposefully selected sample of N≥12 000). Exclusion criteria: experience of self-administered injectable; previously enrolled in pilot RCT; ‘very willing’ to start insulin as baseline. Outcomes will be assessed via online survey at 2 weeks and 6 months. Primary outcome between-group: difference in mean negative Insulin Treatment Appraisal Scores (ITAS negative) at 2-week and 6-month follow-up. Secondary outcomes: between-group differences in mean positive insulin appraisals (ITAS positive) and percentage difference in intention to commence insulin at follow-up time points. All data analyses will be conducted according to the intention-to-treat principle.Ethics and disseminationDeakin University Human Research Ethics Committee (2020–073). Dissemination via peer-reviewed journals, conferences and a plain-language summary.Trial registration numberACTRN12621000191897; Australian and New Zealand Clinical Trials Registry.
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Zadro, Joshua R., Christopher Needs, Nadine E. Foster, David Martens, Danielle M. Coombs, Gustavo C. Machado, Cameron Adams, Christopher S. Han, and Christopher G. Maher. "Feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’) for patients with low back pain: protocol for a feasibility and pilot randomised controlled trial." BMJ Open 12, no. 1 (January 2022): e056339. http://dx.doi.org/10.1136/bmjopen-2021-056339.
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IntroductionLong waiting time is an important barrier to accessing recommended care for low back pain (LBP) in Australia’s public health system. This study describes the protocol for a randomised controlled trial (RCT) that aims to establish the feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’), which aims to reduce waiting times for LBP.Methods and analysisWe will conduct a single-centre feasibility and pilot RCT with nested qualitative interviews. Sixty participants with LBP newly referred to a hospital outpatient clinic will be randomised to receive Rapid Stratified Telehealth or usual care. Rapid Stratified Telehealth involves matching the mode and type of care to participants’ risk of persistent disabling pain (using the Keele STarT MSK Tool) and presence of potential radiculopathy. ‘Low risk’ patients are matched to one session of advice over the telephone, ‘medium risk’ to telehealth physiotherapy plus App-based exercises, ‘high risk’ to telehealth physiotherapy, App-based exercises, and an online pain education programme, and ‘potential radiculopathy’ fast tracked to usual in-person care. Primary outcomes include the feasibility of delivering Rapid Stratified Telehealth (ie, acceptability assessed through interviews with clinicians and patients, intervention fidelity, appointment duration, App useability and online pain education programme usage) and evaluating Rapid Stratified Telehealth in a future trial (ie, recruitment rates, consent rates, lost to follow-up and missing data). Secondary outcomes include waiting times, number of appointments, intervention and healthcare costs, clinical outcomes (pain, function, quality of life, satisfaction), healthcare use and adverse events (AEs). Quantitative analyses will be descriptive and inform a future adequately-powered RCT. Interview data will be analysed using thematic analysis.Ethics and disseminationThis study has received approval from the Ethics Review Committee (RPAH Zone: X21-0221). Results will be published in peer-reviewed journals and presented at conferences.Trial registration numberACTRN12621001104842.
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Harries, P., K. J. Gilhooly, M. L. Gilhooly, M. Davies, and D. C. Kinnear. "ELDER FINANCIAL ABUSE: AN RCT FOR THE DEVELOPMENT OF AN ONLINE TRAINING TOOL FOR PROFESSIONALS." Innovation in Aging 1, suppl_1 (June 30, 2017): 990. http://dx.doi.org/10.1093/geroni/igx004.3579.
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Bao, Lei, Xiaxia Cai, Meihong Xu, and Yong Li. "Effect of oat intake on glycaemic control and insulin sensitivity: a meta-analysis of randomised controlled trials." British Journal of Nutrition 112, no. 3 (April 30, 2014): 457–66. http://dx.doi.org/10.1017/s0007114514000889.
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The present meta-analysis of randomised controlled trials (RCT) aimed to investigate the effect of oat intake on glycaemic control and insulin sensitivity. A literature search was carried out in PubMed, ScienceDirect Online and The Cochrane Library (up to October 2013) for RCT that assessed the effect of oat intake on glucose control and insulin sensitivity. A total of fifteen articles with 673 subjects met the inclusion criteria. A random-effects model was used when the overall pooled studies exhibited significant heterogeneity. Otherwise, a fixed-effects model was used. Compared with controls, oat intake significantly reduced the concentrations of fasting insulin by − 6·29 (95 % CI − 12·32, − 0·27) pmol/l (P= 0·04) and the values of glucose AUC (GAUC; 0–120 min) by − 30·23 (95 % CI − 43·65, − 16·81) min × mmol/l (P< 0·0001). There was a slight decrease in fasting glucose concentrations, glycated Hb concentrations and homeostatic model assessment-insulin resistance values in subjects who consumed oats, but the difference was not significant. In conclusion, oat intake significantly lowers fasting insulin concentrations and GAUC values. To further investigate the effect of oat intake on fasting glucose concentrations, additional long-term and high-quality RCT with a parallel design are required.
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O'Higgins, Siobhan, Jennifer Stinson, Sara Ahola Kohut, Line Caes, Caroline Heary, and Brian E. McGuire. "Lending an Ear: iPeer2Peer plus Teens Taking Charge online self-management to empower adolescents with arthritis in Ireland: protocol for a pilot randomised controlled trial." BMJ Open 9, no. 12 (December 2019): e027952. http://dx.doi.org/10.1136/bmjopen-2018-027952.
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IntroductionJuvenile idiopathic arthritis (JIA) negatively affects adolescents’ everyday activities. To address the need for innovative, effective, convenient, low-cost psychosocial self-management programmes, we developed an Irish version of Canadian Teens Taking Charge (TTC) and integrated it with Skype-based peer support iPeer2Peer (iP2P).ObjectivesTo explore the feasibility and preliminary outcome impact (effectiveness) of an integrated iP2P and Irish TTC, via three-arm (treatment as usual, TTC and iP2P–TTC) pilot randomised controlled trial (RCT); and determine feasibility and sample size for a full RCT. To ensure active involvement of adolescents with JIA via a Young Person Advisory Panel and examine how participants experienced the study. Finally, to see if TTC and iP2P with TTC reduce costs for families.Methods and analysisRecruitment of 60 families will be ongoing until July 2019, via healthcare professionals and support groups. Analysis will consist of single-blinded (outcome assessment), three-arm pilot RCT, using online questionnaires, with assessments at baseline (T1), after intervention (T2) and 3 months post-intervention (T3). The primary outcomes on feasibility with comparisons of TTC and iP2P–TTC on fidelity, acceptability and satisfaction, engagement and degrees of tailoring. The secondary outcomes will be self-management and self-efficacy and a range of health-related quality-of-life factors, pain indicators and costs.Participants from the intervention groups will be invited to share their perspectives on the process in semistructured interviews. Quantitative data will be analysed using SPSS V.21 and the audio-taped and transcribed qualitative data will be analysed using qualitative content analysis.DisseminationVia journal articles, conference presentations, co-delivered by key stakeholders when possible, launch of accessible, effective and sustainable Internet self-management and peer support for Irish adolescents with JIA.Trial registration numberISRCTN13535901; Pre-results.
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Mellish, Louise C., Colin Dunkley, Colin D. Ferrie, and Deb K. Pal. "Antiepileptic drug treatment of rolandic epilepsy and Panayiotopoulos syndrome: clinical practice survey and clinical trial feasibility." Archives of Disease in Childhood 100, no. 1 (September 8, 2014): 62–67. http://dx.doi.org/10.1136/archdischild-2013-304211.
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BackgroundThe evidence base for management of childhood epilepsy is poor, especially for the most common specific syndromes such as rolandic epilepsy (RE) and Panayiotopoulos syndrome (PS). Considerable international variation in management and controversy about non-treatment indicate the need for high quality randomised controlled trials (RCT). The aim of this study is, therefore, to describe current UK practice and explore the feasibility of different RCT designs for RE and PS.MethodsWe conducted an online survey of 590 UK paediatricians who treat epilepsy. Thirty-two questions covered annual caseload, investigation and management practice, factors influencing treatment, antiepileptic drug preferences and hypothetical trial design preferences.Results132 responded (22%): 81% were paediatricians and 95% at consultant seniority. We estimated, annually, 751 new RE cases and 233 PS cases. Electroencephalography (EEG) is requested at least half the time in approximately 70% of cases; MRI brain at least half the time in 40%–65% cases and neuropsychological evaluation in 7%–8%. Clinicians reported non-treatment in 40%: main reasons were low frequency of seizures and parent/child preferences. Carbamazepine is the preferred older, and levetiracetam the preferred newer, RCT arm. Approximately one-half considered active and placebo designs acceptable, choosing seizures as primary and cognitive/behavioural measures as secondary outcomes.ConclusionsManagement among respondents is broadly in line with national guidance, although with possible overuse of brain imaging and underuse of EEG and neuropsychological assessments. A large proportion of patients in the UK remains untreated, and clinicians seem amenable to a range of RCT designs, with carbamazepine and levetiracetam the preferred active drugs.
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Arnobit, Celine Isabelle, Kiana Loo, Ian Pagano, Mai Uchiyama, Jami Fukui, Christa Braun-Inglis, and Erin O’Carroll Bantum. "Recruiting Cancer Survivors to a Mobile Mindfulness Intervention in the United States: Exploring Online and Face-to-Face Recruitment Strategies." International Journal of Environmental Research and Public Health 18, no. 19 (September 27, 2021): 10136. http://dx.doi.org/10.3390/ijerph181910136.
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Cancer survivorship research faces several recruitment challenges, such as accrual of a representative sample, as well as participant retention. Our study explores patterns in recruited demographics, patient-reported outcomes (PROs), and retention rates for a randomized controlled trial (RCT) utilizing a mobile mindfulness intervention for the well-being of cancer survivors. In total, 123 participants were recruited using traditional and online strategies. Using the chi-square test of independence, recruitment type was compared with demographic and clinical variables, PROs, and retention at Time 2 and Time 3. Online recruitment resulted in almost double the yield compared to traditional recruitment. Online-recruited participants were more often younger, from the continental U.S., Caucasian, diagnosed and treated less recently, at a later stage of diagnosis, diagnosed with blood cancer, without high blood pressure, and with less reported pain. The recruitment method was not significantly associated with retention. Online recruitment may capture a larger, broader survivor sample, but, similar to traditional recruitment, may also lead to selection biases depending on where efforts are focused. Future research should assess the reasons underlying the higher yield and retention rates of online recruitment and should evaluate how to apply a mix of traditional and online recruitment strategies to efficiently accrue samples that are representative of the survivor population.
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Knouse, Laura E., Xiaodi Hu, George Sachs, and Sebastian Isaacs. "Usability and feasibility of a cognitive-behavioral mobile app for ADHD in adults." PLOS Digital Health 1, no. 8 (August 15, 2022): e0000083. http://dx.doi.org/10.1371/journal.pdig.0000083.
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Objective Cognitive-behavioral therapy (CBT) has growing evidence of efficacy for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. Mobile health apps are promising tools for delivering scalable CBT. In a 7-week open study of Inflow, a CBT-based mobile app, we assessed usability and feasibility to prepare for a randomized controlled trial (RCT). Method 240 adults recruited online completed baseline and usability assessments at 2 (n = 114), 4 (n = 97) and after 7 weeks (n = 95) of Inflow use. 93 participants self-reported ADHD symptoms and impairment at baseline and 7 weeks. Results Participants rated Inflow’s usability favorably, used the app a median of 3.86 times per week, and a majority of those using the app for 7 weeks self-reported decreases in ADHD symptoms and impairment. Conclusion Inflow demonstrated usability and feasibility among users. An RCT will determine whether Inflow is associated with improvement among more rigorously assessed users and beyond non-specific factors.
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Vargas-Salfate, Salvador, Dario Paez, James H. Liu, Felicia Pratto, and Homero Gil de Zúñiga. "A Comparison of Social Dominance Theory and System Justification: The Role of Social Status in 19 Nations." Personality and Social Psychology Bulletin 44, no. 7 (March 15, 2018): 1060–76. http://dx.doi.org/10.1177/0146167218757455.
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This study tests specific competing hypotheses from social dominance theory/realistic conflict theory (RCT) versus system justification theory about the role of social status. In particular, it examines whether system justification belief and effects are stronger among people with low socioeconomic status, and in less socially developed and unequal nations than among better-off people and countries. A cross-national survey was carried out in 19 nations from the Americas, Western and Eastern Europe, Asia, and Oceania using representative online samples ( N = 14,936, 50.15% women, Mage = 41.61 years). At the individual level, system justification beliefs, right-wing authoritarianism, social dominance orientation, national identification, sociopolitical conservatism, sex, age, and social status were measured. At the national level, the human development index and the Gini index were used. Multilevel analyses performed indicated that results fit better with the social dominance/RCT approach, as system justification was higher in high-status and developed nations; further, associations between legitimizing ideologies and system justification were stronger among high-status people.
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Musil, Carol M., Jaclene Zauszniewski, Alexandra Jeanblanc, McKenzie Wallace, Christina Henrich, Chris Burant, and Elizabeth Tracy. "GIFT: GRANDMOTHER INITIATIVES IN FAMILY TRANSFORMATION." Innovation in Aging 3, Supplement_1 (November 2019): S356. http://dx.doi.org/10.1093/geroni/igz038.1293.
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Abstract Little research has been conducted on the development and testing of interventions to support grandmothers during their caregiving experience. Our descriptive and pilot intervention studies provide the foundation for converting a face-to-face resourcefulness intervention into an NIH-funded self-administered, online intervention for grandmother caregivers, to determine its impact on individual health and family well-being. The online intervention provides personal and social resourcefulness training using online video content and structured reflective journaling to reinforce resourcefulness skills compared to reflective journaling. We are testing the resourcefulness intervention in a randomized clinical trial (RCT) with a national sample of 334 grandmothers living with/raising grandchildren, comparing the resourcefulness training protocol vs. unstructured journaling alone. Given the limited interventions available to grandmother caregivers, an intervention that transcends time and place and is available 24 hours a day is expected to bolster the personal and social resourcefulness, which will in turn affect individual and family outcomes.
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Johnson, Rowan W., Sian A. Williams, Daniel F. Gucciardi, Natasha Bear, and Noula Gibson. "Can an online exercise prescription tool improve adherence to home exercise programmes in children with cerebral palsy and other neurodevelopmental disabilities? A randomised controlled trial." BMJ Open 10, no. 12 (December 2020): e040108. http://dx.doi.org/10.1136/bmjopen-2020-040108.
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ObjectiveDetermine the adherence to and effectiveness of an 8-week home exercise programme for children with disabilities delivered using Physitrack, an online exercise prescription tool, compared with traditional paper-based methods.DesignSingle-blinded, parallel-groups, randomised controlled trial (RCT).SettingIntervention took place in participants’ homes in Western Australia.ParticipantsChildren aged 6 to 17 years, with neurodevelopmental disabilities including cerebral palsy (CP), receiving community therapy services.InterventionAll participants completed an individualised home exercise programme, which was delivered to the intervention group using Physitrack and conventional paper-based methods for the control group.Primary outcome measuresAdherence to exercise programme, goal achievement and exercise performance.Secondary outcome measuresEnjoyment, confidence and usability of Physitrack.ResultsFifty-four participants with CP (n=37) or other neurodevelopmental disabilities (n=17) were recruited. Fifty-three were randomised after one early withdrawal. Forty-six completed the 8-week programme, with 24 in the intervention group and 22 in the control group. There was no difference between the two groups for percentage of exercises completed (intervention (n=22): 62.8% (SD 27.7), control (n=22): 55.8% (SD 19.4), between group mean difference −7.0% (95% CI: −21.6 to 7.5, p=0.34)). Both groups showed significant improvement in their self-rated performance of individualised goal activities, however there was no statistically significant difference between groups for goal achievement, quality of exercise performance, enjoyment, confidence or preferred method of delivery. There were no adverse events.ConclusionPhysitrack provides a therapist with a new means of providing an exercise programme with online tools such as exercise videos, but our preliminary findings indicate that it may be no better than a traditional paper-based method for improving exercise adherence or the other outcomes measured. Exercise programmes remain an intervention supported by evidence, but a larger RCT is required to fully evaluate online delivery methods.Trial registration detailsAustralian New Zealand Clinical Trials Registry; ACTRN12616000743460.
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Warrington, Lorraine, Kate Absolom, Patricia Holch, Andrea Gibson, Beverly Clayton, and Galina Velikova. "Online tool for monitoring adverse events in patients with cancer during treatment (eRAPID): field testing in a clinical setting." BMJ Open 9, no. 1 (January 2019): e025185. http://dx.doi.org/10.1136/bmjopen-2018-025185.
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ObjectivesElectronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online system developed to support patient care during cancer treatment by improving the detection and management of treatment-related symptoms. Patients can complete symptom reports from home and receive severity-based self-management advice, including notifications to contact the hospital for severe symptoms. Patient data are available in electronic records for staff to review. Prior to the commencement of a randomised controlled trial (RCT), field testing of the intervention was undertaken to troubleshoot practical issues with intervention integration in clinical practice.DesignObservational clinical field testing.SettingMedical oncology breast service in a UK cancer centre.Participants12 patients receiving chemotherapy for early breast cancer and 10 health professionals (oncologists and specialist nurses).InterventionPatients were asked to use the eRAPID intervention and complete weekly online symptom reports during four cycles of chemotherapy. Clinical staff were invited to access and use patient data in clinical assessments.AnalysisDescriptive data on the frequency of online symptom report completion and severe symptom notifications were collated. Verbal and written feedback was collected from patients and staff and semistructured interviews were conducted to explore patient experiences. Interviews were transcribed and analysed thematically.ResultsThe testing ran from January 2014 to March 2014. Feedback from patients and staff was largely positive. Patients described eRAPID as ‘reassuring’ and ‘comforting’ and valued the tailored management advice. Several changes were made to refine eRAPID. In particular, improvement of the clinical notification, patient reminder systems and changes to patient and staff training.ConclusionsThe field testing generated valuable results used to guide refinement of eRAPID prior to formal intervention evaluation. Feedback indicated that eRAPID has the potential to improve patients’ self-efficacy, knowledge and confidence with managing symptoms during treatment. A large-scale RCT is underway with data collection due to finish in October 2018.
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Franke, Nike, Louise J. Keown, and Matthew R. Sanders. "An RCT of an Online Parenting Program for Parents of Preschool-Aged Children With ADHD Symptoms." Journal of Attention Disorders 24, no. 12 (September 8, 2016): 1716–26. http://dx.doi.org/10.1177/1087054716667598.
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Objective: This randomized control trial evaluated the efficacy of an online self-help program in a sample of parents of preschoolers with ADHD symptoms. Method: Parents were randomly assigned to the intervention group ( n = 27) or the delayed intervention group ( n = 26). Child behavior measures were completed by mothers, fathers, and teachers, and parenting measures were completed by mothers. Results: Intent-to-treat analyses indicated significant post-intervention improvements in mother-rated child hyperactivity/inattention, restlessness/impulsivity, defiance/aggression, social functioning, and teacher-rated prosocial behavior, as well as significant improvements in maternal over-reactivity, verbosity, laxness, positive parenting, parenting satisfaction, self-efficacy, stress, and depression. At 6-month follow-up, effects were maintained for maternal over-reactivity and verbosity, parenting satisfaction and self-efficacy, and parental stress and depression. Conclusion: This study provides evidence for the effectiveness of an online self-help parenting program in reducing preschool inattentive behavior difficulties, and in increasing parenting competence, satisfaction in the parenting role, and maternal well-being.
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Douma, Miriam, Charlotte P. Bouman, Hedy A. van Oers, Heleen Maurice-Stam, Lotte Haverman, Martha A. Grootenhuis, and Linde Scholten. "Matching Psychosocial Support Needs of Parents of a Child with a Chronic Illness to a Feasible Intervention." Maternal and Child Health Journal 24, no. 10 (July 1, 2020): 1238–47. http://dx.doi.org/10.1007/s10995-020-02925-3.
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Abstract Objectives Parents of children with a chronic illness (CI) are at risk for psychosocial problems. The aim of this study was to refine an existing face-to-face intervention into an online psychosocial group intervention for parents by (1) exploring which themes are important, (2) determine what type of intervention parents would like and (3) assess parents’ practical preferences. Methods Parents of children with a CI (0–18 years) were invited to complete an online questionnaire. To acquire more in-depth information, focus groups and telephone interviews were conducted. Descriptive statistics were used. Results 272 parents (mean age = 43.1 years, 85% female) participated. Three focus groups (15 parents) and seven telephone interviews were conducted. Most important themes were: the CI of the child, family functioning, taking care of yourself, relationships with others and practical support. Parents preferred a group with parents of children in the same age category. At first, parents preferred face-to-face contact. After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home. Conclusions for Practice Parents have a need for psychosocial support focusing on different themes. Professionals should explain and demonstrate an online intervention to parents. Based on these results, Op Koers Online for parents was developed. An RCT to assess feasibility and effectiveness of the intervention is currently running.
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Araya, Roberto, and Karina Diaz. "Implementing Government Elementary Math Exercises Online: Positive Effects Found in RCT under Social Turmoil in Chile." Education Sciences 10, no. 9 (September 11, 2020): 244. http://dx.doi.org/10.3390/educsci10090244.
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The impact of online math programs depends on its implementation, especially in vulnerable populations from developing countries. An existing online platform was adapted, at the request of the Chilean Ministry of Education, to exclusively include exercises previously designed and tested by a paper-based government program for elementary school. We carried out a cluster-randomized controlled trial (RCT) with 50 fourth grade classrooms. Treatment classrooms used the platform in a weekly 90-min math session. Due to a social instability outbreak in the country, a large unexpected disruption with huge absenteeism occurred in the second half of the semester, which turned this study into a unique opportunity to explore the robustness of the platform’s effects on students’ learning. Using multiple imputation and multilevel models, we found a statistically significant effect size of 0.13, which corresponds to two extra months of learning. This effect is meaningful for four reasons. First, it has double the effect of the paper-based version. Second, it was achieved during one semester only. Third, is half that obtained with the platform for a complete year with its own set of exercises and with two sessions per week instead of one. Fourth, it was attained in a semester with a lot of absenteeism.
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Mettes, T. G., W. J. M. van der Sanden, E. Bronkhorst, R. P. T. M. Grol, M. Wensing, and A. J. M. Plasschaert. "Impact of Guideline Implementation on Patient Care: a Cluster RCT." Journal of Dental Research 89, no. 1 (December 4, 2009): 71–76. http://dx.doi.org/10.1177/0022034509350971.
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In Western European countries, dentists use standardized procedures, rather than individualized risk assessment, for routine oral examinations. The predictive hypothesis was that guideline implementation strategies based on multifaceted interventions would be more effective in patient care than the dissemination of guidelines only. A cluster-randomized trial was conducted, with groups of general dental practitioners (GDPs) as the unit of randomization. Patients were clustered within practices and prospectively enrolled in the trial. Patient data were collected from registration forms. The primary outcome measure was guideline-adherent recall assignment, and a secondary outcome measure was guideline-adherent bitewing frequency. The interventions consisted of online training, guideline dissemination, and educational sessions. For low-risk patients, guideline-adherent recall increased in the intervention group (+8%), which differed from the control group (−6.1%) (p = 0.01). Guideline-adherent bitewings showed mixed results. We conclude that multifaceted intervention had a moderate but relevant effect on the performance of GDPs, which is consistent with other findings in primary care.
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Smith, Sophia Kustas, Kristin MacDermott, and Sathya Amarasekara. "A randomized control trial (RCT) of an online, symptom self-management curriculum (Reimagine) among breast cancer survivors." Journal of Clinical Oncology 35, no. 5_suppl (February 10, 2017): 182. http://dx.doi.org/10.1200/jco.2017.35.5_suppl.182.
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182 Background: Chronic pain, depression, and fatigue are common effects resulting from the cancer experience (e.g., disease, treatment); new interventions are needed. Reimagine is an online symptom self-management program that teaches coping skills. This presentation will report on the impact of Reimagine on key health outcomes. Methods: Adult breast cancer survivors with chronic pain were recruited from the Susan Love Army of Women volunteer registry. Consenting participants were randomized 1:1 to the treatment or usual care condition and completed surveys at Baseline and 18 weeks (post-intervention). Treatment arm participants accessed content online; required activities included viewing online videos, attending online group meetings, and completing cognitive reframing exercises. Surveys were administered via REDCap to assess for pain severity and interference (primary outcome), depression, fatigue, and program satisfaction. An independent-samples t-test was conducted to compare change in pain, depression, and fatigue outcomes in treatment and usual care conditions. Results: Participants (n = 91) were: mean age 56.4 ± 8.8 years; 99% female; 94% white; 67% married; 46% employed; mean time since diagnosis 7.9 ± 6.4 years; and 89% were in remission or cured of their breast cancer. There was a significant difference in the change in depression scores for treatment (M = -1.7, SD = 4.7) and usual care (M = 0.3, SD = 3.8) conditions; t (82) = -2.1, p = 0.035. Difference in the change in fatigue scores was significant for treatment (M = 4.8, SD = 9.1) and usual care (M = 1.2, SD = 6.6) conditions; t (84) = 2.1, p = .038. No significant differences were found in the change in pain outcomes for treatment and usual care conditions (p > .05). Most treatment arm participants (94%) would recommend Reimagine to others and 85% felt more resilient at study completion. Conclusions: These results suggest that Reimagine has an effect on depression and fatigue symptoms for breast cancer survivors. Additional research is recommended with larger and more diverse samples. Trial (NCT02465892) was funded by Pfizer, Inc. Clinical trial information: NCT02465892.
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Musil, Carol, and Alexandra Jeanblanc. "Management and Analysis of Large Qualitative Data Sets: Lessons Learned From Daily Journals for a Behavioral RCT." Innovation in Aging 5, Supplement_1 (December 1, 2021): 82–83. http://dx.doi.org/10.1093/geroni/igab046.315.
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Abstract As part of a national RCT of a resourcefulness skills training intervention, 342 grandmother caregivers, completed daily online journals for 4 weeks, reporting “challenges or difficulties you faced today with your grandchildren or other family members and how you handled them.” In this paper, we describe the challenges and benefits of using an entirely online design for the distribution and collection of daily journals. We used NVIVO-12 Plus to perform directed content analysis to assess intervention enactment fidelity and compare content between intervention (trained in and prompted to discuss skills) and control groups. Over 92%(n=317) of participants completed daily journals. There was variation in reporting of skill use between groups: 36% of controls spontaneously used the skill “seek professional help” whereas only 4% of the control group reported the skill “change from usual reaction”. With careful management, qualitative data from large samples can be obtained and effectively analyzed for fidelity.