Abstract 13029: Recruitment Success of the mActive Physical Activity mHealth Trial: Can Convenience Increase Enrollment of Eligible Patients and Women Into RCTs?
Background: Evidence from randomized controlled trials (RCTs) is critical to clinical decision-making, but RCTs often do not meet recruitment goals, limiting power and generalizability. Only ~58% of eligible patients typically enroll in cardiovascular RCTs and certain subgroups, such as women, are commonly underrepresented. Prior work has generated the hypothesis that convenient trial designs (e.g., use of mobile follow-up) could enhance RCT participation.
Methods: The mActive trial (NCT01917812), a 5-week blinded, randomized mHealth trial of digital activity tracking and text messaging, enrolled adult cardiology patients at a single academic medical center. Eligible participants were 18-69 year old smartphone users who reported a low amount of leisure-time physical activity on the International Physical Activity Questionnaire. The mActive trial differed from the traditional RCT design in that participants did not need to manually record activity or return in person to the study site. Instead, leveraging modern technology, activity data were continuously uploaded through participants’ smartphones.
Results: mActive recruitment substantially outperformed the historical average for cardiovascular RCTs and approached the theoretical ideal (figure). Of 50 individuals who screened eligible for the mActive trial, 48 (96%) enrolled. Twenty-two women and 26 men participated with an overall mean age of 58±8 years. Participants were primarily Caucasian (78%) and from a wide variety of professions.
Conclusions: The mActive trial recruitment experience supports the hypothesis that a trial design fostering convenience can enhance RCT participation. mActive recruited nearly all eligible participants and almost equal proportions of women and men from an adult cardiology clinic. Future trials are necessary to determine which aspects of the mActive trial can be scaled to larger and longer-term RCTs.
Author Disclosures: S.S. Martin: None. D.I. Feldman: None. R.S. Blumenthal: None. S.R. Jones: None. E.V. Ratchford: None. J. Coresh: None. M.J. Blaha: None.
- © 2014 by American Heart Association, Inc.