DementiaPhase 1NCT05037578
Encouraging Cognitive Screenings at African American Churches
A Phase 1 study testing Project Grace in people with Dementia and Healthy, run by University of Kansas Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- What is being tested?
- Project Grace
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 30 Jun 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Medicine, UMKC
Kansas City, Missouri, 64108
About this study
Official title: A Church-based Intervention for Increasing Screening for Dementia Among African American Older Adults (ADC Pilot): Project Grace
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.
Read the 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.
- Being tested
- Project Grace
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project GraceBehavioural
A multilevel church-based intervention to encourage cognitive screens and brain health.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Project Grace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Jul 2019
- Primary completion19 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037578
- Sponsor's protocol ID
- 2017382 KC
- Status last verified
- May 2023
- First submitted
- 31 Aug 2021
- Last updated
- 26 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Church-based Intervention for Increasing Screening for Dementia Among African American Older Adults (ADC Pilot): Project Grace
- ClinicalTrials.gov ID
- NCT05037578
- Acronym / sponsor ID
- 2017382 KC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of Missouri, Kansas City
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Posted 26 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project Grace | Experimental | Behavioral: Project GraceThis 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 Control | Active comparator | Behavioral: Project GraceStandard 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project GraceA multilevel church-based intervention to encourage cognitive screens and brain health. | Behavioural | Project Grace, Standard Control |
Primary outcome
Number of Participants Who Received a Cognitive Screening
Time frame: 4 months from baseline
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
Time frame: 4 months from baseline
Question at 4 months from baseline asking whether the participant has received a linkage to care services within the last 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Project Grace in people with Dementia and Healthy, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Received a Cognitive Screening (time frame: 4 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.