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| ID | Type | Description | Link |
|---|---|---|---|
| 5K76AG060005 | U.S. NIH Grant/Contract | View source | |
| A534100 | Other Identifier | UW Madison | |
| Emergency Medicine | Other Identifier | UW Madison | |
| Protocol Version | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain Health Community Registry Recruitment | Active Comparator |
| |
| Standard Recruitment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relational Research Recruitment and Engagement Intervention | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled in Each Recruitment Arm | Number of participants enrolled in the Brain Health Community Registry | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Retained Over Time | Number of participants in the Brain Health Community Registry | 10 months |
| 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. |
Inclusion Criteria for Participants Ages 40 or Older:
Inclusion Criteria for Caregiver Participants Ages 18 or Older:
Exclusion Criteria for Participants Ages 40 or Older:
Exclusion Criteria for Caregiver Participants Ages 18 or Older:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea L Gilmore-Bykovskyi, PhD, RN | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
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No participants have been enrolled into the Standard Recruitment arm as of grant closeout on 5/31/2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brain Health Community Registry Recruitment | Relational Research Recruitment and Engagement Intervention:
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2023 |
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| 10 months |
| FG001 | Standard Recruitment | No specified recruiter/point of contact Limited flexibility in study time, place, method of recruitment and follow-up No resource matching |
| COMPLETED |
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| NOT COMPLETED |
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No participants were recruited for the standard recruitment arm as of study closeout on 5/31/2023.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brain Health Community Registry Recruitment | Relational Research Recruitment and Engagement Intervention:
|
| BG001 | Standard Recruitment |
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| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Participants Requesting Resources | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Enrolled in Each Recruitment Arm | Number of participants enrolled in the Brain Health Community Registry | No participants were enrolled in the Standard Recruitment arm as of study closeout (5/31/2023). Analysis only accounts for the Brain Health Community Registry Recruitment Arm. | Posted | Count of Participants | Participants | 10 months |
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| Secondary | Number of Participants Retained Over Time | Number of participants in the Brain Health Community Registry | No participants were enrolled in the Standard Recruitment arm as of study closeout (5/31/2023). Analysis only accounts for the Brain Health Community Registry Recruitment Arm. | Posted | Count of Participants | Participants | 10 months |
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| Other Pre-specified | 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. | No participants were enrolled in the Standard Recruitment arm as of study closeout (5/31/2023). Analysis only accounts for the Brain Health Community Registry Recruitment Arm. | Posted | Count of Participants | Participants | 10 months |
|
10 months
No participants were enrolled in the Standard Recruitment arm as of study closeout (5/31/2023). Risk for Serious Adverse Events, All-Cause Mortality, and Other (Not Including Serious) Adverse Events only accounts for the Brain Health Community Registry Recruitment Arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brain Health Community Registry Recruitment | Relational Research Recruitment and Engagement Intervention:
| 0 | 182 | 0 | 182 | 0 | 182 |
| EG001 | Standard Recruitment |
| 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Gilmore-Bykovskyi | University of Wisconsin School of Medicine and Public Health | 6082623057 | algilmore@wisc.edu |
| Nov 14, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2022 | May 7, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D020961 | Lewy Body Disease |
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D057174 | Frontotemporal Lobar Degeneration |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| >=65 years |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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