A Relational Research Recruitment and Engagement Intervention for Cognitive Aging Research

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05444244

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Cognitive Dysfunction Alzheimer Disease Lewy Body Disease Frontotemporal Dementia	Other: Relational Research Recruitment and Engagement Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of participants enrolled in each recruitment arm [Immediately after delivery]
Number of participants enrolled in each recruitment arm

Secondary Outcome Measures

Number of participants retained over time [3 months, 6 months, and 12 months]
Number of participants retained over time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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