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Published on: August 1, 2019
Barriers encountered during enrollment in an internet-mediated randomized controlled trial
Lorraine R Buis1, Adrienne W Janney, Michael L Hess
1Department of Family Medicine, University of Michigan Health Systems, Ann Arbor, MI, USA. buisl@wayne.edu
Online clinical trials face enrollment challenges. Participants often need help with complex processes, especially older adults, women, and those less familiar with the internet.
Area of Science:
- Digital Health
- Clinical Research Informatics
Background:
- Online technology offers potential for broader reach and efficiency in clinical research.
- However, internet-mediated studies present unique challenges for participants and researchers.
- This study focuses on enrollment barriers in an online walking intervention trial.
Purpose of the Study:
- To identify challenges faced by potential participants during the enrollment phase of an internet-mediated walking program.
- To analyze help desk data to understand common enrollment issues.
Main Methods:
- Quantitative content analysis of 623 help tickets from the Stepping Up to Health trial enrollment.
- Qualitative coding by two coders to identify themes and inter-coder reliability.
- Descriptive statistics and Poisson regression to analyze ticket characteristics and participant demographics.
Main Results:
- 38% of website visitors logged help tickets; average 0.71 tickets per participant.
- Most common issues: study process (48%), medical clearance (34%), pedometer/uploading (31%).
- Older individuals, women, and those with lower self-rated internet ability reported more problems.
Conclusions:
- Online clinical trial participants encounter enrollment barriers, necessitating help from study staff.
- Complex, multi-step enrollment processes are a significant source of participant issues.
- Personalized status feedback during enrollment may mitigate challenges.
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