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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05037578
Enrollment
99
Registered
2021-09-08
Start date
2019-07-01
Completion date
2021-06-30
Last updated
2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Healthy

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.

Interventions

BEHAVIORALProject Grace

A multilevel church-based intervention to encourage cognitive screens and brain health.

Sponsors

University of Missouri, Kansas City
CollaboratorOTHER
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Received a Cognitive Screening4 months from baselineQuestion 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 Services4 months from baselineQuestion at 4 months from baseline asking whether the participant has received a linkage to care services within the last 4 months

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
62
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.
37
Total99

Baseline characteristics

CharacteristicStandard ControlTotalProject Grace
Age, Continuous68.4 years
STANDARD_DEVIATION 8.3
68.7 years
STANDARD_DEVIATION 8.4
68.9 years
STANDARD_DEVIATION 8.6
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants95 Participants60 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants4 Participants2 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
37 Participants99 Participants62 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
37 participants99 participants62 participants
Sex: Female, Male
Female
31 Participants82 Participants51 Participants
Sex: Female, Male
Male
6 Participants17 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 620 / 37
other
Total, other adverse events
0 / 620 / 37
serious
Total, serious adverse events
0 / 620 / 37

Outcome results

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

Time frame: 4 months from baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Project GraceNumber of Participants Who Received a Cognitive Screening5 Participants
Standard ControlNumber of Participants Who Received a Cognitive Screening11 Participants
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

Time frame: 4 months from baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Project GraceNumber of Participants Who Were Linked to Care Services5 Participants
Standard ControlNumber of Participants Who Were Linked to Care Services11 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026