title: Barriers encountered during enrollment in an internet-mediated randomized controlled trial.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00729040.
authors.affiliation: Department of Family Medicine, University of Michigan Health Systems, Ann Arbor, MI, USA. buisl@wayne.edu
authors.forename: Lorraine R
authors.initials: LR
authors.lastname: Buis
authors.forename: Adrienne W
authors.initials: AW
authors.lastname: Janney
authors.forename: Michael L
authors.initials: ML
authors.lastname: Hess
authors.forename: Silas A
authors.initials: SA
authors.lastname: Culver
authors.forename: Caroline R
authors.initials: CR
authors.lastname: Richardson
mesh_terms: D000328:Adult; D000368:Aged; D005246:Feedback; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D010358:Patient Participation; D016032:Randomized Controlled Trials as Topic
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