Abstract
BACKGROUND/PURPOSE: Participant engagement such as intervention adherence and study retention are critical to evaluating treatment efficacy and clinical trial success. Investigations of navigators among patients with chronic illness report improved health-related outcomes; however, little is known about the effects of navigators in healthy populations or on participant engagement in clinical trials. The purpose of this study was to explore whether peer navigators - former study participants - enhanced intervention adherence or study retention in a clinical trial among healthy older adults. METHODS: We conducted a study within a randomized clinical trial (SWAT) among community-dwelling older adults (N = 268) by assigning a subsample of participants to peer navigators (n = 36). Six former trial participants served as peer navigators. Statistical analyses explored whether navigator assignment was associated with intervention adherence or study retention. RESULTS: Participants assigned to a navigator were not different from the overall trial sample and were, on average, 71 years of age (SD = 5) with 16 years of education (SD = 3); 56 % identified as female, 81 % as White, and 3 % as Hispanic. Navigator assignment was associated with better intervention adherence, t(134.2) = -6.0, p < .001; participants with a navigator completed an average of 5 more sessions (M = 20, SD = 3) compared to those without a navigator (M = 15, SD = 8). Retention was higher among navigator-assigned participants (100 % vs. 76 %), X(2) (1, N = 261) = 10.0, p = .002. CONCLUSIONS: Peer navigators may improve intervention adherence and study retention among older adults in clinical trials. Results suggest that personalized support by a peer may enhance participant engagement in clinical trials, but replication is needed. The data are from the registered clinical trial: Interventions to Attenuate Cognitive Decline, https://clinicaltrials.gov/study/NCT03528486.