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| Name | Class |
|---|---|
| University of Missouri, Kansas City | OTHER |
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This pilot study plans 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Project Grace | Experimental | 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. |
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| Standard Control | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project Grace | Behavioral | A multilevel church-based intervention to encourage cognitive screens and brain health. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received a Cognitive Screening | Question at 4 months from baseline asking whether the participant has received a cognitive screening within the last 4 months | 4 months from baseline |
| Number of Participants Who Were Linked to Care Services | Question at 4 months from baseline asking whether the participant has received a linkage to care services within the last 4 months | 4 months from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medicine, UMKC | Kansas City | Missouri | 64108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Project Grace: A multilevel church-based intervention to encourage cognitive screens and brain health. |
| FG001 | 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. Project Grace: A multilevel church-based intervention to encourage cognitive screens and brain health. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Project Grace: A multilevel church-based intervention to encourage cognitive screens and brain health. |
| 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, Continuous | Mean |
| 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 Who Received a Cognitive Screening | Question at 4 months from baseline asking whether the participant has received a cognitive screening within the last 4 months | Posted | Count of Participants | Participants | 4 months from baseline |
|
4 months
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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 | 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. Project Grace: A multilevel church-based intervention to encourage cognitive screens and brain health. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime Perales Puchalt | University of Kansas Alzheimer's Disease Research Center | 913-588-3716 | jperales@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 21, 2022 | May 23, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| BG001 | 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. Project Grace: A multilevel church-based intervention to encourage cognitive screens and brain health. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. Project Grace: A multilevel church-based intervention to encourage cognitive screens and brain health. |
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| Primary | Number of Participants Who Were Linked to Care Services | Question at 4 months from baseline asking whether the participant has received a linkage to care services within the last 4 months | Posted | Count of Participants | Participants | 4 months from baseline |
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| 0 |
| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | 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. Project Grace: A multilevel church-based intervention to encourage cognitive screens and brain health. | 0 | 37 | 0 | 37 | 0 | 37 |
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| D001523 | Mental Disorders |