Research
Barriers encountered during enrollment in an internet-mediated randomized controlled trial
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* Corresponding author: Caroline R Richardson caroli@umich.edu
1 Wayne State University, College of Nursing - Adult Health, 5557 Cass Avenue, Detroit, MI, USA
2 University of Michigan Health Systems, Department of Family Medicine, 1018 Fuller St., Ann Arbor, MI, USA
3 University of Michigan Medical School, c/o Department of Family Medicine, 1018 Fuller St., Ann Arbor, MI, USA
4 Ann Arbor Veteran Affairs Medical Center, Center for Clinical Management Research, HSR&D/SMITREC (11H), P.O. Box 130170, Ann Arbor, MI, USA
Trials 2009, 10:76 doi:10.1186/1745-6215-10-76
Published: 23 August 2009Abstract
Background
Online technology is a promising resource for conducting clinical research. While the internet may improve a study's reach, as well as the efficiency of data collection, it may also introduce a number of challenges for participants and investigators. The objective of this research was to determine the challenges that potential participants faced during the enrollment phase of a randomized controlled intervention trial of Stepping Up to Health, an internet-mediated walking program that utilized a multi-step online enrollment process.
Methods
We conducted a quantitative content analysis of 623 help tickets logged in a participant management database during the enrollment phase of a clinical trial investigating the effect of an automated internet-mediated walking intervention. Qualitative coding was performed by two trained coders, and 10% of the sample was coded by both coders to determine inter-coder reliability. Quantitative analyses included standard descriptive statistics on ticket characteristics and theme frequency, and a Poisson regression analysis identified characteristics of potential participants who reported more frequent problems during enrollment.
Results
In total, 880 potential participants visited the study website and 80% completed the enrollment screening. Of the potential participants who visited the study website, 38% had help tickets logged in the participant management database. The total number of help tickets associated with individual potential participants ranged from 0 to 7 (M = .71). Overall, 46% of help tickets were initiated by email and 54% were initiated by phone. The most common help ticket theme was issues related to the study process (48%). The next most prominent theme was discussion related to obtaining medical clearance (34%), followed by issues related to pedometers and uploading (31%). Older individuals, women, and those with lower self-rated internet ability were more likely to report problems during the enrollment process.
Conclusion
Prospective participants in an online clinical trial encountered a number of barriers to enrollment that led them to request help from study staff. Questions about the complex enrollment process itself were common. In a complex multi-step enrollment process, providing personalized feedback to potential participants indicating their status within the enrollment process may be beneficial.
Trial Registration
ClinicalTrials.gov NCT00729040