Barriers encountered during enrollment in an internet-mediated randomized controlled trial.
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.
Buis
Lorraine R
LR
Department of Family Medicine, University of Michigan Health Systems, Ann Arbor, MI, USA. buisl@wayne.edu
Janney
Adrienne W
AW
Hess
Michael L
ML
Culver
Silas A
SA
Richardson
Caroline R
CR
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
J Med Internet Res. 2008 Nov 18;10(5):e40
19017582
Evid Based Dent. 2008;9(4):118-20
19151687
Obstet Gynecol. 2000 Oct;96(4):636-9
11041770
J Med Internet Res. 2008 Nov 20;10(4):e44
19033149
Int J Behav Nutr Phys Act. 2007 Nov 16;4:59
18021411
J Med Internet Res. 2007 May 09;9(2):e11
17513282
Obesity (Silver Spring). 2006 Feb;14(2):266-72
16571852
Soc Psychiatry Psychiatr Epidemiol. 2000 May;35(5):220-7
10941997
J Med Internet Res. 2009 Apr 03;11(2):e9
19403465
Nurse Res. 2005;13(2):55-70
16416980
Behav Res Ther. 2005 Mar;43(3):277-92
15680926