NCT05037578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

August 31, 2021

Results QC Date

July 8, 2022

Last Update Submit

May 24, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

Behavioral: Project Grace

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.

Behavioral: Project Grace

Interventions

Project GraceBEHAVIORAL

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

Project GraceStandard Control

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine, UMKC

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Jaime Perales Puchalt
Organization
University of Kansas Alzheimer's Disease Research Center

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 8, 2021

Study Start

July 1, 2019

Primary Completion

June 19, 2021

Study Completion

June 30, 2021

Last Updated

May 26, 2023

Results First Posted

May 26, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations