Trial Outcomes & Findings for Encouraging Cognitive Screenings at African American Churches (NCT NCT05037578)
NCT ID: NCT05037578
Last Updated: 2023-05-26
Results Overview
Question at 4 months from baseline asking whether the participant has received a cognitive screening within the last 4 months
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
99 participants
Primary outcome timeframe
4 months from baseline
Results posted on
2023-05-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
37
|
|
Overall Study
COMPLETED
|
54
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Encouraging Cognitive Screenings at African American Churches
Baseline characteristics by cohort
| Measure |
Project Grace
n=62 Participants
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.
|
Standard Control
n=37 Participants
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.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=5 Participants
|
37 participants
n=7 Participants
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 months from baselineQuestion at 4 months from baseline asking whether the participant has received a cognitive screening within the last 4 months
Outcome measures
| Measure |
Project Grace
n=62 Participants
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.
|
Standard Control
n=37 Participants
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.
|
|---|---|---|
|
Number of Participants Who Received a Cognitive Screening
|
5 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 4 months from baselineQuestion at 4 months from baseline asking whether the participant has received a linkage to care services within the last 4 months
Outcome measures
| Measure |
Project Grace
n=62 Participants
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.
|
Standard Control
n=37 Participants
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.
|
|---|---|---|
|
Number of Participants Who Were Linked to Care Services
|
5 Participants
|
11 Participants
|
Adverse Events
Project Grace
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jaime Perales Puchalt
University of Kansas Alzheimer's Disease Research Center
Phone: 913-588-3716
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place