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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05037578
Other study ID # 2017382 KC
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 1, 2019
Est. completion date June 30, 2021

Study information

Verified date May 2023
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date June 30, 2021
Est. primary completion date June 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Project Grace
A multilevel church-based intervention to encourage cognitive screens and brain health.

Locations

Country Name City State
United States School of Medicine, UMKC Kansas City Missouri

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center University of Missouri, Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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 4 months from baseline
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 4 months from baseline
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