- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05037578
Encouraging Cognitive Screenings at African American Churches
A Church-based Intervention for Increasing Screening for Dementia Among African American Older Adults (ADC Pilot): Project Grace
Study Overview
Detailed Description
The primary aim of this study is to conduct an exploratory pilot study to examine feasibility and outcomes of a culturally/religiously-tailored church-based dementia screening intervention among older adult African American church members and community members who use church outreach services in 4 African American churches (N=100). Our secondary outcomes are to assess the impact of the intervention on dementia-related stigma and linkage to care. Intervention content is based on the Theory of Planned Behavior; intervention delivery is based on the Social-Ecological Model - both guided by a faith community engagement approach. Trained faith leaders will deliver the tailored intervention through multilevel church outlets: individual self-help resources (e.g., risk checklist, commitment to screening cards); group ministry discussion guides/seminar on dementia; church-wide services using sermon guides, responsive readings, and church bulletin inserts; and church-community level text messages, dementia screening, and linkage to care services. Two screening events will be held at each church. We will also conduct a process evaluation that will include post-test study focus groups.
Specific Aim 1. Test a religiously/culturally-tailored, church-based dementia screening intervention on receipt of dementia screening, stigma, and linkage to care use among an older adult African American church-populations at 4 months.
Hypothesis. The tailored church-based dementia screening intervention will evidence increased screening and linkage to care rates, and lower dementia-related stigma beliefs at 4 months.
Specific Aim 2. Evaluate predictors of receipt of dementia screening at 4 months among older adult African American church-populations to determine modifiable screening facilitators/barriers.
Specific Aim 3. Conduct a process evaluation to examine study intervention implementation facilitators, barriers, and dose along with exposure and satisfaction to identify essential intervention components.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Missouri
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Kansas City, Missouri, United States, 64108
- School of Medicine, UMKC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥55
- Regular church member (attending church > monthly) or community member receiving church outreach services (>3 times annually)
- Willing to participate in two surveys (baseline and 4 months)
- Willing to provide contact information for at least 2 other persons
- Residing in the Kansas City metropolitan area
- Provide a working contact email address or number
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard Control
Standard information churches will receive standard dementia education information.
These churches will receive: a) non-tailored project materials collected from mental health organizations and b) standard community-based mental health screening events) coordinated by their Community Health Liaisons.
These churches will receive all Project Grace Tool Kit materials and implementation training after the completion of assessments.
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A multilevel church-based intervention to encourage cognitive screens and brain health.
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Experimental: Project Grace
This intervention will be delivered through church-based multilevel activities by trained church leaders using religiously/ culturally-tailored study materials (sermon guides, responsive readings, educational games, brochures, educational/testimonial videos) packaged in a culturally-tailored.
Intervention churches will receive the Project Grace Tool Kit and intervention implementation directions to seek cognitive screening.
These churches will hold a Project Grace Kickoff event, where a sermon, and other tool kit materials will be distributed.
After the Kick-off, liaisons will deliver 1-2 Tool Kit materials/activities per month through targeted multilevel church activities over 4 months.
Delivery of intervention components will coincide with existing, multilevel activities that occur in churches through: a) church-wide services, b) outreach ministry groups; and c) individual level activities (e.g., text/voice/email health promotion messages from church) over 4 months.
|
A multilevel church-based intervention to encourage cognitive screens and brain health.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of Participants Who Received a Cognitive Screening
Time Frame: 4 months from baseline
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Question at 4 months from baseline asking whether the participant has received a cognitive screening within the last 4 months
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4 months from baseline
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Number of Participants Who Were Linked to Care Services
Time Frame: 4 months from baseline
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Question at 4 months from baseline asking whether the participant has received a linkage to care services within the last 4 months
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4 months from baseline
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017382 KC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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