Recruitment and Retention of Patients With Ischemic Heart Disease Reporting Hopelessness in a Randomized Controlled Trial

BACKGROUND: Identifying effective methods to recruit and retain participants in research is imperative to maximize the generalizability of findings and reduce bias in interventional studies. Historically, studies of hopelessness, defined as a negative outlook and sense of helplessness about the future, have struggled with both recruitment and retention. OBJECTIVE: The purpose of this paper is to describe strategies utilized for recruitment and retention, and quantify their results, in a randomized controlled trial (RCT; Heart Up!) that enrolled participants with ischemic heart disease (IHD) who reported moderate to severe hopelessness. METHODS: At a single U.S. hospital, 681 patients with IHD were screened for state hopelessness using the Dunn State-Trait Hopelessness Scale. Of the 279 eligible for the study, 224 participants chose to enroll (80.2%) in the RCT. Analysis for this paper focused on recruitment and retention results and associated strategies. RESULTS: Of the 224 enrolled, 66 reconsidered study participation before baseline data collection and 27 of the remaining 158 dropped out between the baseline and final 6-month follow-up time point. DISCUSSION: Successful recruitment strategies included regularly meeting with study recruiters to promote fidelity of enrollment strategies, discussing progress towards goals, and identifying the optimal time frame to meet with hospitalized patients to discuss the study. Successful retention strategies included building rapport with both participants and research staff, responding quickly and thoroughly to participant feedback, and consistently meeting with interventionists and data collectors to ensure study fidelity, troubleshoot challenges, and provide encouragement. The results reinforce that individuals reporting moderate to severe hopelessness require ample time from study staff at enrollment and throughout the study. Future researchers should consider expanding the recruitment timeline to reduce attrition between enrollment and first data collection visit.