A Relational Research Recruitment and Engagement Intervention for Cognitive Aging Research

NCT ID: NCT05444244

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-05-31

Brief 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.

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

Dementia; Cognitive Dysfunction; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Brain Health Community Registry Recruitment

Group Type: ACTIVE_COMPARATOR

Relational Research Recruitment and Engagement Intervention

Intervention Type: OTHER

• 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)

Standard Recruitment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

Other Intervention Names

Brain Health Community Registry Recruitment Intervention

Eligibility Criteria

Inclusion Criteria

• English-speaking
• Interested in learning about research opportunities related to aging, brain health, and caregiving
• If evidence of a lack of decision-making capacity is present, presence and consent from a legally authorized representative (LAR) in addition to assent from the participant with cognitive challenges

• English-speaking
• Has had previous or current contact (phone, in-person, coordination of services, etc.) with a person with Alzheimer's disease or related dementia at least monthly and provides unpaid support to the individual which can be health, financial, social, or logistical in nature
• Interested in learning about research opportunities related to aging and brain health, particularly related to care for people living with Alzheimer's disease or related dementia

Exclusion Criteria

• Is not interested in learning about research opportunities related to aging and brain health
• Under 40 years of age and/or no ADRD caregiving experience
• Evidence of a lack of decision-making capacity and LAR cannot be found or contacted
• Populations who are completely blind or completely deaf

• Frequency of contact with the person with ADRD is or has been less than monthly
• Nature of contact does not involve providing supports for person with ADRD, or caregiver is paid for supports
• Under 18 years of age
• Populations who are completely blind or completely deaf

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea L Gilmore-Bykovskyi, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5K76AG060005

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A534100

Identifier Type: OTHER

Identifier Source: secondary_id

Emergency Medicine

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1148

Identifier Type: -

Identifier Source: org_study_id