A Patient-Centered Analysis of Enrollment and Retention in a Randomized Behavioral Trial of Two Cognitive Rehabilitation Interventions for Mild Cognitive Impairment

Abstract

BACKGROUND: A major potential barrier for studying behavioral interventions for patients with Mild Cognitive Impairment (MCI) is the willingness and ability of people to enroll in and adhere to behavioral interventions, especially when the intervention involves dyads of patients with MCI and support partners. Details regarding recruitment strategies and processes (such as number of dyads screened) are often missing from reports of behavioral trials. In addition, reports do not detail the reasons a potentially eligible candidate opts out of participation in a research study. OBJECTIVES: To describe the challenges and successes of enrollment and retention in a behavioral trial for persons with MCI and their care partners, and to better understand barriers to participation from the patient’s point of view. DESIGN: Multi-site, randomized trial. SETTING: Major medical centers. PARTICIPANTS: Our accrual target for the study was 60 participants. Potential candidates were patients presenting to memory evaluation clinics whose resulting clinical diagnosis was MCI. A total of 200 consecutive potential candidates were approached about participating in the study across the three sites. INTERVENTION: Detailed recruitment and retention data of a randomized trial comparing two behavioral interventions (memory notebook training versus computer training) provided in two separate training time frames (10 days versus 6 weeks). MEASUREMENTS: Structured interview with those declining to participate in the trial. RESULTS: Overall recruitment 37% with a range of 13%-72% across sites. Overall retention 86% with a range of 74%-94% across sites. CONCLUSIONS: The primary barriers to enrollment from the patient’s perspective were distance to the treatment center and competing comprehensive behavioral programming. However, retention data suggest that those dyads who enroll in behavioral programs are highly committed.

Dyadic Enrollment in a Phase 3 Mild Cognitive Impairment Clinical Trial

“…That the majority of participants enrolled with a spouse study partner is consistent with AD dementia trials 5,16 and other MCI research. [17][18][19][20] The current data do not explain the apparent recruitment bias. It is possible that MCI participants lacking a spouse may have been differentially excluded.…”

Comparative Effectiveness of Behavioral Interventions on Quality of Life for Older Adults With Mild Cognitive Impairment

“…We attained a high (84%) retention rate, in keeping with a previous recruitment and retention trial in a different sample of 86% (range, 74%-94%). 15 In all groups, most outcomes were improved by end of treatment, although by 12 months most outcomes were no longer significant. These within-group trajectories must be interpreted cautiously because there was no untreated control group in this study.…”

“…We planned to recruit 300 dyads that consisted of a patient with MCI and a partner, anticipating an approximate 10% attrition rate based on prior research. 15 Participants were recruited through clinical services at the Mayo Clinic on the Rochester, Minnesota, Scottsdale, Arizona, and Jacksonville, Florida, campuses as well as at the University of Washington in Seattle from September 1, 2014, to August 31, 2016, with the last follow-up on March 31, 2018 and the last day of analysis on March 6, 2019. Consecutive candidates with a diagnosis of amnestic MCI (single or multidomain) 2 were screened as potential study participants.…”

Recruitment of a multi‐site randomized controlled trial of aerobic exercise for older adults with amnestic mild cognitive impairment: The EXERT trial

“…Recruitment of adults with MCI into nonpharmacological trials is particularly difficult, given the additional study demands associated with adherence to a behavioral intervention. 1 , 2 , 3 , 4 Barriers to recruitment of adults with MCI into such trials include stringent medical eligibility criteria and the time and effort required of participants that could impact motivation to enroll. 1 , 2 , 3 , 4 Individuals recruited from memory clinics versus the community tend to have more advanced MCI and may not be representative of the broader population of adults with early‐stage MCI.…”

“… 1 , 2 , 3 , 4 Barriers to recruitment of adults with MCI into such trials include stringent medical eligibility criteria and the time and effort required of participants that could impact motivation to enroll. 1 , 2 , 3 , 4 Individuals recruited from memory clinics versus the community tend to have more advanced MCI and may not be representative of the broader population of adults with early‐stage MCI. 2 , 5 Severity of cognitive impairment in the study sample could impact the participant's ability to adhere to a complex intervention and the expected cognitive trajectory.…”