Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05444244 |
| Other study ID # |
2019-1148 |
| Secondary ID |
5K76AG060005A534 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2022 |
| Est. completion date |
May 31, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
University of Wisconsin, Madison |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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. 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. The investigators propose to test the effectiveness of the
Brain Health Community (BHC) Registry recruitment and engagement intervention, as compared to
standard research recruitment strategies in modifying enrollment rates, participant
satisfaction, and engagement. The investigators hypothesize that the BHC Registry will yield
greater enrollment rates, higher satisfaction, and better ratings of relational engagement.
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)
