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Encouraging Cognitive Screenings at African American Churches

Primary Purpose

Dementia, Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Project Grace
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age ≥55
  2. Regular church member (attending church > monthly) or community member receiving church outreach services (>3 times annually)
  3. Willing to participate in two surveys (baseline and 4 months)
  4. Willing to provide contact information for at least 2 other persons
  5. Residing in the Kansas City metropolitan area
  6. Provide a working contact email address or number

Exclusion Criteria:

  • None

Sites / Locations

  • School of Medicine, UMKC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Project Grace

Standard Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
May 24, 2023
Sponsor
University of Kansas Medical Center
Collaborators
University of Missouri, Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT05037578
Brief Title
Encouraging Cognitive Screenings at African American Churches
Official Title
A Church-based Intervention for Increasing Screening for Dementia Among African American Older Adults (ADC Pilot): Project Grace
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 19, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
University of Missouri, Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Healthy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Project Grace
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Project Grace
Intervention Description
A multilevel church-based intervention to encourage cognitive screens and brain health.
Primary Outcome Measure Information:
Title
Number of Participants Who Received a Cognitive Screening
Description
Question at 4 months from baseline asking whether the participant has received a cognitive screening within the last 4 months
Time Frame
4 months from baseline
Title
Number of Participants Who Were Linked to Care Services
Description
Question at 4 months from baseline asking whether the participant has received a linkage to care services within the last 4 months
Time Frame
4 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
School of Medicine, UMKC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Encouraging Cognitive Screenings at African American Churches

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