PREVENTABLE will need to randomize 20,000 participants over age 75 across most geographic regions of the United States to determine the role of a moderate-intensity statin in preventing dementia, including Alzheimer?s disease, and prolonging disability-free survival in patients 75 years and older without clinically evident coronary heart disease, including those with frailty, impaired physical function, mild cognitive impairment, polypharmacy, and multi-morbidity. Recruitment into clinical trials is challenging and enrolling older adults can be particularly difficult. Participants must also include large numbers of women, racial and ethnic minorities, very old adults, and people with frailty, limited mobility, cognitive impairment (including Alzheimer?s disease) and comorbidities. Unique barriers to recruiting and retaining older adults include lack of perceived benefits and relevance of study, unfamiliarity with research, difficulty understanding and reading the consent, burdensome study visits, transportation to study visits, refusal by family members who share in decision making, and a perceived burden on clinical teams involved in recruitment. If not addressed, these will result in a study that is underpowered, not generalizable, or longer and more expensive than anticipated. Clinicians? enthusiasm for referring patients to and endorsing primary prevention studies will also be critical. The Recruitment and Retention Core will be under the leadership of Dr. Consuelo Wilkins of Vanderbilt University and Dr. Schuyler Jones of DCRI. This core will provide recruitment and engagement expertise in a distributed and tailored manner across sites with robust infrastructure, tools, resources, and innovative strategies to proactively address recruitment barriers and rapidly mitigate roadblocks. This comprehensive approach, involving all stages of the study ? design, planning, protocol development, start-up, Vanguard, implementation, and dissemination ? will facilitate development of a high quality, feasible protocol, minimize challenges, and optimize recruitment and retention. We will partner with the Trial Innovation Network and leverage the competency of our team with participant-centered approaches that recognize the varying needs and preferences of older adults and authentic engagement of patients, community groups and clinicians to ensure maximal retention into the study.
AIM 1 : Catalyze enrollment of older adults including women, racial and ethnic minorities, mild cognitively impaired persons (including those with Alzheimer?s disease), frail, and very old individuals.
AIM 2 : Integrate stakeholder input into the study protocol, recruitment and retention strategies, and feedback on the participant experience.
AIM 3 : Engage primary care clinicians to understand barriers to randomization and minimize burden and ensure value to clinical staff.
AIM 4 : Implement, study, and iterate a variety of strategies to enhance recruitment and retention.
