scholarly journals Participant Recruitment and Retention in Remote eHealth Intervention Trials: Methods and Lessons Learned From a Large Randomized Controlled Trial of Two Web-Based Smoking Interventions

10.2196/10351 ◽  
2018 ◽  
Vol 20 (8) ◽  
pp. e10351 ◽  
Author(s):  
Noreen L Watson ◽  
Kristin E Mull ◽  
Jaimee L Heffner ◽  
Jennifer B McClure ◽  
Jonathan B Bricker
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Web Based ◽  
Participant Recruitment ◽  
Recruitment And Retention ◽  
Randomized Controlled ◽  
Intervention Trials ◽  
Ehealth Intervention

scholarly journals Web-Based Intervention for Women With Type 1 Diabetes in Pregnancy and Early Motherhood: Critical Analysis of Adherence to Technological Elements and Study Design (Preprint)

2017 ◽  
Author(s):  
Marie Berg ◽  
Karolina Linden ◽  
Annsofie Adolfsson ◽  
Carina Sparud Lundin ◽  
Agneta Ranerup
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Controlled Trial ◽  
Systems Design ◽  
Lessons Learned ◽  
Health Interventions ◽  
Web Based ◽  
Randomized Controlled ◽  
Persuasive Systems Design ◽  
Persuasive Systems

BACKGROUND Numerous Web-based interventions have been implemented to promote health and health-related behaviors in persons with chronic conditions. Using randomized controlled trials to evaluate such interventions creates a range of challenges, which in turn can influence the study outcome. Applying a critical perspective when evaluating Web-based health interventions is important. OBJECTIVE The objective of this study was to critically analyze and discuss the challenges of conducting a Web-based health intervention as a randomized controlled trial. METHOD The MODIAB-Web study was critically examined using an exploratory case study methodology and the framework for analysis offered through the Persuasive Systems Design model. Focus was on technology, study design, and Web-based support usage, with special focus on the forum for peer support. Descriptive statistics and qualitative content analysis were used. RESULTS The persuasive content and technological elements in the design of the randomized controlled trial included all four categories of the Persuasive Systems Design model, but not all design principles were implemented. The study duration was extended to a period of four and a half years. Of 81 active participants in the intervention group, a maximum of 36 women were simultaneously active. User adherence varied greatly with a median of 91 individual log-ins. The forum for peer support was used by 63 participants. Although only about one-third of the participants interacted in the forum, there was a fairly rich exchange of experiences and advice between them. Thus, adherence in terms of social interactions was negatively affected by limited active participation due to prolonged recruitment process and randomization effects. Lessons learned from this critical analysis are that technology and study design matter and might mutually influence each other. In Web-based interventions, the use of design theories enables utilization of the full potential of technology and promotes adherence. The randomization element in a randomized controlled trial design can become a barrier to achieving a critical mass of user interactions in Web-based interventions, especially when social support is included. For extended study periods, the technology used may need to be adapted in line with newly available technical options to avoid the risk of becoming outdated in the user realm, which in turn might jeopardize study validity in terms of randomized controlled trial designs. CONCLUSIONS On the basis of lessons learned in this randomized controlled trial, we give recommendations to consider when designing and evaluating Web-based health interventions.

scholarly journals The Healing Hearts Together Randomized Controlled Trial and the COVID-19 Pandemic: A Tutorial for Transitioning From an In-Person to a Web-Based Intervention

10.2196/25502 ◽  
2021 ◽  
Vol 23 (4) ◽  
pp. e25502
Author(s):  
Kathleen Lalande ◽  
Paul S Greenman ◽  
Karen Bouchard ◽  
Susan M Johnson ◽  
Heather Tulloch
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiovascular Health ◽  
Transition Planning ◽  
Controlled Trial ◽  
Web Based ◽  
Participant Recruitment ◽  
Randomized Controlled ◽  
Health Quality ◽  
Step Transition

Supportive couple relationships are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as improved secondary prevention. Healing Hearts Together (HHT) is an 8-week couples-based intervention designed to improve relationship quality, mental health, quality of life, and cardiovascular health among couples in which one partner has experienced a cardiac event. A randomized controlled trial began in October 2019 to test the efficacy of the in-person, group-based HHT program as compared to usual care. In March of 2020, all recruitment, assessments, and interventions halted due to the COVID-19 pandemic. Guided by optimal virtual care principles, as well as by Hom and colleagues’ four-stage framework—consultation, adaptation, pilot-testing, and test launch—this paper is a tutorial for the step-by-step transition planning and implementation of a clinical research intervention from an in-person to a web-based format, using the HHT program as an example. Clinical and research considerations are reviewed, including (1) privacy, (2) therapeutic aspects of the intervention, (3) group cohesion, (4) research ethics, (5) participant recruitment, (6) assessment measures, (7) data collection, and (8) data analyses. This tutorial can assist clinical researchers in transitioning their research programs to a web-based format during the pandemic and beyond.

scholarly journals The Healing Hearts Together Randomized Controlled Trial and the COVID-19 Pandemic: A Tutorial for Transitioning From an In-Person to a Web-Based Intervention (Preprint)

2020 ◽  
Author(s):  
Kathleen Lalande ◽  
Paul S Greenman ◽  
Karen Bouchard ◽  
Susan M Johnson ◽  
Heather Tulloch
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiovascular Health ◽  
Transition Planning ◽  
Controlled Trial ◽  
Web Based ◽  
Participant Recruitment ◽  
Randomized Controlled ◽  
Health Quality ◽  
Step Transition

UNSTRUCTURED Supportive couple relationships, are associated with reduced risk of chronic illness development, such as cardiovascular disease, as well as improved secondary prevention. Healing Hearts Together (HHT) is an 8-week couples-based intervention designed to improve relationship quality, mental health, quality of life, and cardiovascular health among couples in which one partner has experienced a cardiac event. A randomized controlled trial (RCT) began in October 2019 to test the efficacy of the in-person, group-based HHT program as compared to usual care. In March of 2020, all recruitment, assessments, and interventions halted due to the COVID-19 pandemic. Guided by optimal virtual care principles, and Hom and colleagues’ (2020) four-stage framework (consultation, adaptation, pilot testing, and test launch), this paper is a tutorial for the step-by-step transition planning and implementation of a clinical research intervention from in-person to a web-based platform, using the HHT program as an example. Clinical and research considerations are reviewed, including; (1) privacy; (2) therapeutic aspects of the intervention; (3) group cohesion; (4) research ethics; (5) participant recruitment; (6)assessment measures; (7) data collection; and, (8) data analyses. This tutorial can assist clinical researchers transitioning their research programs to a web-based format during the pandemic and beyond.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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