Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: Results and lessons learned

Abstract

BackgroundObesity 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.MethodsBe 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.ResultsActive 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.ConclusionWe 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.Trial registrationClinicaltrials.gov Identifier: NCT00661817

Feasibility study of a single-blind randomised controlled trial of an occupational therapy intervention

“…Recruitment has been a problem in many trials (e.g., 3,29) and is widely recognised as a challenge (30,31). The resistance of stakeholders is often cited as a reason for low recruitment (e.g., 30, 32, 33, 34) supporting the results of our study.…”

Predictors of Retention Among African Americans in a Randomized Controlled Trial to Test the Healthy Eating and Active Living in the Spirit (HEALS) Intervention

“…31 We found that control group allocation, normal BMI, having a partner enrolled in study, and low levels of stress (at least in crude analyses) were associated with increased retention.…”

“…Future studies with larger sample sizes and longer-term endpoints complete the 24-month visit than those in the usual/control group. 31 One strength of this study is the availability of a wide range of covariates that were utilized in the analysis. To our knowledge, this is the first study that was able to identify the role of enrolling a partner and the ability it may have in determining retention of AAs in RCTs.…”

Tackling the challenges in conducting a 5‐year longitudinal study of the Healthy Beginnings Trial

“…These retention strategies are commonly used in other studies. [4][5][6][7] We found the use of an SMS text out service 1 month before a scheduled home visit was useful in identifying changes to participants' details, identifying disconnected mobile phone numbers and allowing alternative methods of contacting participants. With the increasing use of mobile phones in the community, many participants no longer used a landline, and we found them more likely to communicate via text message.…”

“…These retention rates were similar to other studies. [4][5][6][7] A review of the circumstances under which participants dropped out of the trial was conducted and is shown in Table 1. Participants who dropped out of the program tended to be younger mothers on a lower income with a lower level of education.…”