Trials / Completed

CompletedNCT05444244

A Relational Research Recruitment and Engagement Intervention for Cognitive Aging Research

Novel Approaches to Identifying and Engaging Disadvantaged Patients With Alzheimer's Disease (AD) in Clinical Research

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 182 (actual)

Sponsor: University of Wisconsin, Madison · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

Detailed description

Despite well-documented disparities in Alzheimer's disease and related dementia (AD) prevalence, incidence, treatment, and mortality, individuals from disadvantaged backgrounds (e.g. racial/ethnic minorities and socioeconomically disadvantaged persons) are under-represented in clinical research. This poses a major barrier for efforts to better understand how disease risk factors and protective factors influence ADRD progression, and determinants of observed disparities. The National Institute on Aging has highlighted the need for development of an applied recruitment science to advance ADRD research, and enable systematic investigation of ADRD health disparities. Existing research on optimal ADRD research recruitment, engagement, and retention strategies is sparse, and focuses predominantly on individual-level characteristics, many of which may not be modifiable. Much of this research also overlooks the role of structural and social determinants, along with features of the study design in shaping participation decisions. People with ADRD and their caregivers commonly face financial, social, emotional, and logistical (i.e. time scarcity) consequences in relation to dementia, that disproportionately burden disadvantaged populations, yet are overlooked in research recruitment and engagement approaches. Existing research recruitment approaches are rarely designed to accommodate the priorities, concerns, and constraints relevant to participants from diverse backgrounds. To address these gaps, the investigators developed a research recruitment and engagement model, the Participant Oriented Research Engagement Model that centers and prioritizes relational aspects of research engagement, research participant needs, and systematically address socioeconomic determinants (i.e. unmet needs) that may limit accessibility of research. Core constructs within the model are implemented within an applied research recruitment and engagement intervention, the Brain Health Community (BHC) Registry which applies systematic, tailored, and relational recruitment strategies and standardized connections to resources as an element of the research engagement process. The investigators propose to test the effectiveness of the BHC Registry recruitment and engagement intervention, as compared to standard research recruitment strategies in modifying enrollment rates, participant satisfaction, and engagement. Each approach will be evaluated in a randomized trial to either BHC Registry or Standard Recruitment (SR). The relative benefit of these two approaches will be evaluated in a crossover trial of 60 participants who will be randomized in a 2:1 ratio. The investigators hypothesize that the BHC Registry will yield greater enrollment rates, higher satisfaction, and better ratings of relational engagement. Upon completion of the study, participants who received SR will be invited to participate in the BHC Registry. Aim 1: To compare the BHC Registry to SR with respect to enrollment factors. Aim 2: To compare the BHC Registry to SR with respect to participant satisfaction and relational engagement. Hypothesis A: Tailored and relational recruitment strategies used in BHC Registry will result in higher enrollment, lower rates of refusal, and lower drop-out rates. Hypothesis B: Tailored and relational recruitment strategies used in BHC Registry will result in higher participant satisfaction ratings. Hypothesis C: Tailored and relational recruitment strategies used in the BHC Registry will yield better ratings of relational engagement. Hypothesis D: Tailored and relational recruitment strategies used in BHC Registry will result in more favorable attitudes toward research as assessed by the Clinical Research Involvement Scale (CRIS)

Conditions

Interventions

Type	Name	Description
OTHER	Relational Research Recruitment and Engagement Intervention	* Specified recruiter/point of contact * Flexibility in study time, place, method of recruitment (preferred participant email, phone), and follow-up (in registry, if participant calls back at all restart 3 failed phone contacts) * Resource matching (financial, transportation constraints)

Timeline

Start date: 2022-08-01
Primary completion: 2023-05-31
Completion: 2023-05-31
First posted: 2022-07-05
Last updated: 2025-05-15
Results posted: 2024-02-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05444244. Inclusion in this directory is not an endorsement.