Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: Results and lessons learned
1 Department of Epidemiology, Harvard School of Public Health, 677 Huntington Ave, Boston, MA, USA
2 Center for Community-Based Research, Division of Population Sciences, Dana Farber Cancer Institute, 375 Longwood Ave, Boston, MA, USA
3 Channing Division of Network Medicine, Brigham and Women’s Hospital, 181 Longwood Ave, Boston, MA, USA
4 Division of Cancer Control and Population Sciences, National Cancer Institute, 6130 Executive Boulevard, Executive Plaza North, Rockville, MD, USA
5 Department of Society, Human Development, and Health, Harvard School of Public Health, 677 Huntington Ave, Boston, MA, USA
6 Department of Psychology and Neuroscience, Duke University, Box 90086, Durham, NC, USA
7 Duke Global Health Institute, Duke University, Box 90086, Durham, NC, USA
8 Department of Biostatistics, Harvard School of Public Health, 677 Huntington Ave., Boston, MA, USA
9 Department of Medicine, Harvard Medical School, 25 Shattuck St., Boston, MA, USA
10 Department of Surgery, Alvin J. Siteman Cancer Center, Washington University School of Medicine, Saint Louis, MO, USA
Citation and License
BMC Public Health 2013, 13:192 doi:10.1186/1471-2458-13-192Published: 6 March 2013
Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status. Recruitment and retention of these populations in research trials, and retention in weight loss trials has been an ongoing challenge.
Be Fit, Be Well was a pragmatic randomized weight loss and hypertension management trial of patients attending one of three community health centers in Boston, Massachusetts. Participants were asked to complete follow-up assessments every 6-months for two years. We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention. We also identify baseline participant characteristics associated with retention status. Retention strategies included financial incentives, contact between assessment visits, building relationships with health center primary care providers (PCPs) and staff, and putting participant convenience first.
Active refusal rates were low with 130 of 2,631 patients refusing participation (4.9%). Of 474 eligible persons completing telephone screening, 365 (77.0%) completed their baseline visit and were randomized into the study. The study population was predominantly non-Hispanic Black (71.2%), female (68.5%) and reported annual household income of less than $35,000 (70.1%). Recruitment strategies included use of passive approval of potential participants by PCPs, use of part-time staff, and outsourcing calls to a call center. A total of 314 (86.0%) people completed the 24-month visit. Retention levels varied across study visits and intervention condition. Most participants completed three or more visits (69.6%), with 205 (56.2%) completing all four. At 24-months, lower retention was observed for males and the intervention condition. Retention strategies included building strong relationships with clinic staff, flexibility in overcoming participant barriers through use of taxi vouchers, night and weekend appointments, and keeping participants engaged via newsletters and social gatherings.
We were able to retain 86.0% of participants at 24-months. Recruitment and retention of high percentages of racial/ethnic minorities and lower income samples is possible with planning, coordination with a trusted community setting and staff (e.g. community health centers and RAs), adaptability and building strong relationships.
Clinicaltrials.gov Identifier: NCT00661817