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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia
• Intervention / Treatment: Other: Relational Research Recruitment and Engagement Intervention

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)

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for Participants Ages 40 or Older:

• 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

Inclusion Criteria for Caregiver Participants Ages 18 or Older:

• 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 for Participants Ages 40 or Older:

• 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

Exclusion Criteria for Caregiver Participants Ages 18 or Older:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Brain Health Community Registry Recruitment	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); Other Names: Brain Health Community Registry Recruitment Intervention
No Intervention: Standard Recruitment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Enrolled in Each Recruitment Arm	Number of participants enrolled in the Brain Health Community Registry	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Retained Over Time	Number of participants in the Brain Health Community Registry	10 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Matched With Resources	As part of the Brain Health Community Registry, participants were given the option to have a tailored list of resources created for them. Resources included transportation needs, caregiving support groups, resources related to eyeglasses or hearing aids, food, and other needs. This measure indicates the number of participants out of the 182 total participants that requested and received a personal resource list.	10 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Andrea L Gilmore-Bykovskyi, PhD, RN, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Recruitment Intervention; Recruitment Science; Alzheimer's Disease Research Participation
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Communication Disorders; Language Disorders; Aphasia; Speech Disorders; Frontotemporal Lobar Degeneration; Cognitive Dysfunction; Alzheimer Disease; Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Lewy Body Disease
• Other Study ID Numbers: 2019-1148; 5K76AG060005 (U.S. NIH Grant/Contract); Protocol Version (Other Identifier: UW Madison); A534100 (Other Identifier: UW Madison); Emergency Medicine (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No