DementiaNCT04983693
Dementia-Friendly Faith Villages to Support African American Families
A study testing Dementia-friendly Worship Service in people with Dementia, run by Emory University at 1 site in United States.
Trial summary
The purpose of this project is to develop and test the feasibility and preliminary effects of a program to enhance the capacity of predominantly African American churches to support congregants and their family caregivers who are living with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia-friendly Worship Service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- caring (4 hours/per day of unpaid assistance) for a community-dwelling family or friend experiencing memory impairment
- able to read, speak, and understand English
- community-dwelling with memory impairment
- have a family caregiver willing to participate
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to develop and test the feasibility and preliminary effects of a program to enhance the capacity of predominantly African American churches to support congregants and their family caregivers who are living with dementia. In particular, this project will examine how dementia-friendly faith village worship services support the well-being of caregivers and care recipients in two African American churches.
Read the detailed description
Historically, churches have been the backbone of support for African American families. As a source of informal support, affiliations with churches serve as an extension to the family, providing social support to older African Americans not always available from close family and friends. African Americans often turn to their church and worship services for support when in distress. In recent years, the question that often arises is: "Are African American faith communities living out components of their church doctrine in relation to their love and commitment to one another?" Surprisingly, many African American churches do not have programs to support their congregation's aging-in-community or the families and congregants living with dementia.
African Americans are more likely than other racial/ethnic groups to be diagnosed with Alzheimer's disease or other forms of dementia, and 20% of persons living with dementia will be African American by 2050. Similarly, the number of their family caregivers will rapidly grow over the next 20 years. Currently, approximately 15 million family caregivers in the United States serve as significant care resources for persons living with dementia. Persons living with dementia experience progressive distress and confusion, which produces emotional strain, burden, social isolation, and depression for caregivers. This underscores the need to strengthen support services and identify resources and meaningful activities that promote physical and mental well-being for African American family caregivers and community-dwelling persons living with dementia.
Dementia restricts the person and the caregiver from participating in religious communities and familiar religious practices; both become increasingly uncomfortable in church settings due to fear of embarrassment, uncertainty about the person's behavior, and even stigma. The caregiving experience often leads to social isolation as caregivers devote all of their time to their family members, thus diminishing their ability to attend church and experience an atmosphere that can support them. Churches can also provide opportunities for individuals living with dementia to continue living in meaningful ways. Along with the setting, socializing with others can be a great strength for these individuals and their family members. Faith-based institutions play a significant role in the lives of individuals living with dementia, primarily through being present for them and the family members to support their quality of life. Research has shown separate benefits for caregivers attending church and the role religion plays in elders living with dementia. However, there is little work exploring how participation in religious practices together (caregiver and person living with dementia) might promote quality of life for these families. A dementia-friendly faith village worship service could provide a culturally organic way for such families to retain connection with a powerful social network.
This study will take place in the south Atlanta Metropolitan area. Two predominantly African American churches from Fulton and Fayette counties have been identified and are eager and enthusiastic to participate in this project. Interested caregivers will be screened for family eligibility via phone. If eligible, times will be scheduled to consent in person prior to data collection. Those consenting will agree to take part in baseline data collection, attend six dementia-friendly worship services in person or online, provide post-intervention data, and take part in more in-depth qualitative interviews. Caregivers will complete surveys and take part in interviews, while only observational data will be collected for persons living with dementia (PLWD).
- Conditions
- Dementia
- Being tested
- Dementia-friendly Worship Service
- Keywords
- Dementia family caregiver
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia-friendly Worship ServiceBehavioural
Key elements of dementia-friendly worship services include familiar hymns, prayers and bible stories and short sermons. Participants can attend the worship services either in person or through online video streaming. Participant dyads should watch the six worship services together, over a span of 6 to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dementia-friendly Worship Service | Experimental | Caregiver and persons living with dementia dyads attending six dementia-friendly worship services in person or online. Receives: Behavioral: Dementia-friendly Worship Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Zarit Burden Inventory Score
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
Measured: Baseline, Post-intervention (up to 8 weeks)
Change in Expressive Support Scale Score
Socioemotional support is assessed with the Expressive Support Scale. This instrument includes 8 items measuring the amount of help and support that caregivers receive from relatives and friends. Responses are given on a 4-point scale where 1 = strongly disagree and 4 = strongly agree. Total scores range from 8 to 32 and higher scores indicate greater support.
Measured: Baseline, Post-intervention (up to 8 weeks)
Change in Positive Appraisal of Care Score
Consequential gain is assessed with the Positive Appraisal of Care Scale. This instrument includes 6 items asking about personal, positive aspects of being a caregiver. Responses are given on a 4-point scale where 0 = not at all applicable and 3 = very much applicable. Total scores range from 0 to 18, where higher scores indicate greater positive consequential gain from caregiving.
Measured: Baseline, Post-intervention (up to 8 weeks)
Change in Dyadic Relationship Scale Caregiver Version Score
The caregiver version of the Dyadic Relationship Scale includes 11 items which are responded to on a 4-point scale where 1 = strongly disagree and 4 = strongly agree. There are two subscales which assess dyadic strain (5 items) and positive dyadic interaction (6 items). Total scores for the dyadic strain subscale range from 5 to 20 and higher scores indicate greater levels of strain. Total scores for the positive dyadic interaction subscale range from 6 to 24 and higher scores indicate greater positive interactions.
Measured: Baseline, Post-intervention (up to 8 weeks)
Change in Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD.
Measured: Baseline, Post-intervention (up to 8 weeks)
Change in Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.
Measured: Baseline, Post-intervention (up to 8 weeks)
Observation During Worship Service
For in person worship services, observations will focus on interactions within the dyads, interactions of caregivers with church leaders and members of the congregation, and interactions of the PLWD with church leaders and the congregation. For online worship services the observations will focus on interactions within the dyads, and the response to the service of the PLWD. Observations of actions during the worship services are assessed qualitatively and a summary score is not determined.
Measured: Up to 8 weeks
Secondary outcomes (1)
Post-intervention Interview
A subsample of 15 to 20 caregivers will be asked to participate in an hour-long, qualitative interview to provide in-depth understanding of the feasibility and efficacy of the intervention. There is not a summary score for the interview questions.
Measured: At the end of the intervention (up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 May 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will recruit 45 dyads of African American family caregivers and African American persons living with dementia.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Fayron Epps, Emory University
- Investigators
- Fayron Epps, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983693
- Sponsor's protocol ID
- IRB00114202
- Status last verified
- May 2022
- First submitted
- 22 Jul 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be made available for sharing, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia-Friendly Faith Villages to Support African American Families
- ClinicalTrials.gov ID
- NCT04983693
- Acronym / sponsor ID
- IRB00114202
- Conditions
- Dementia
- Keywords
- Dementia family caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this project is to develop and test the feasibility and preliminary effects of a program to enhance the capacity of predominantly African American churches to support congregants and their family caregivers who are living with dementia. In particular, this project will examine how dementia-friendly faith village worship services support the well-being of caregivers and care recipients in two African American churches.
Detailed description
Historically, churches have been the backbone of support for African American families. As a source of informal support, affiliations with churches serve as an extension to the family, providing social support to older African Americans not always available from close family and friends. African Americans often turn to their church and worship services for support when in distress. In recent years, the question that often arises is: "Are African American faith communities living out components of their church doctrine in relation to their love and commitment to one another?" Surprisingly, many African American churches do not have programs to support their congregation's aging-in-community or the families and congregants living with dementia.
African Americans are more likely than other racial/ethnic groups to be diagnosed with Alzheimer's disease or other forms of dementia, and 20% of persons living with dementia will be African American by 2050. Similarly, the number of their family caregivers will rapidly grow over the next 20 years. Currently, approximately 15 million family caregivers in the United States serve as significant care resources for persons living with dementia. Persons living with dementia experience progressive distress and confusion, which produces emotional strain, burden, social isolation, and depression for caregivers. This underscores the need to strengthen support services and identify resources and meaningful activities that promote physical and mental well-being for African American family caregivers and community-dwelling persons living with dementia.
Dementia restricts the person and the caregiver from participating in religious communities and familiar religious practices; both become increasingly uncomfortable in church settings due to fear of embarrassment, uncertainty about the person's behavior, and even stigma. The caregiving experience often leads to social isolation as caregivers devote all of their time to their family members, thus diminishing their ability to attend church and experience an atmosphere that can support them. Churches can also provide opportunities for individuals living with dementia to continue living in meaningful ways. Along with the setting, socializing with others can be a great strength for these individuals and their family members. Faith-based institutions play a significant role in the lives of individuals living with dementia, primarily through being present for them and the family members to support their quality of life. Research has shown separate benefits for caregivers attending church and the role religion plays in elders living with dementia. However, there is little work exploring how participation in religious practices together (caregiver and person living with dementia) might promote quality of life for these families. A dementia-friendly faith village worship service could provide a culturally organic way for such families to retain connection with a powerful social network.
This study will take place in the south Atlanta Metropolitan area. Two predominantly African American churches from Fulton and Fayette counties have been identified and are eager and enthusiastic to participate in this project. Interested caregivers will be screened for family eligibility via phone. If eligible, times will be scheduled to consent in person prior to data collection. Those consenting will agree to take part in baseline data collection, attend six dementia-friendly worship services in person or online, provide post-intervention data, and take part in more in-depth qualitative interviews. Caregivers will complete surveys and take part in interviews, while only observational data will be collected for persons living with dementia (PLWD).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will recruit 45 dyads of African American family caregivers and African American persons living with dementia.
| Arm | Type | Receives |
|---|---|---|
| Dementia-friendly Worship Service | Experimental | Behavioral: Dementia-friendly Worship ServiceCaregiver and persons living with dementia dyads attending six dementia-friendly worship services in person or online. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18 years of age
- caring (4 hours/per day of unpaid assistance) for a community-dwelling family or friend experiencing memory impairment
- able to read, speak, and understand English
- community-dwelling with memory impairment
- have a family caregiver willing to participate
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 |
|---|---|---|
| Dementia-friendly Worship ServiceKey elements of dementia-friendly worship services include familiar hymns, prayers and bible stories and short sermons. Participants can attend the worship services either in person or through online video streaming. Participant dyads should watch the six worship services together, over a span of 6 to 8 weeks. | Behavioural | Dementia-friendly Worship Service |
Primary outcome
Change in Zarit Burden Inventory Score
Time frame: Baseline, Post-intervention (up to 8 weeks)
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
Change in Expressive Support Scale Score
Time frame: Baseline, Post-intervention (up to 8 weeks)
Socioemotional support is assessed with the Expressive Support Scale. This instrument includes 8 items measuring the amount of help and support that caregivers receive from relatives and friends. Responses are given on a 4-point scale where 1 = strongly disagree and 4 = strongly agree. Total scores range from 8 to 32 and higher scores indicate greater support.
Change in Positive Appraisal of Care Score
Time frame: Baseline, Post-intervention (up to 8 weeks)
Consequential gain is assessed with the Positive Appraisal of Care Scale. This instrument includes 6 items asking about personal, positive aspects of being a caregiver. Responses are given on a 4-point scale where 0 = not at all applicable and 3 = very much applicable. Total scores range from 0 to 18, where higher scores indicate greater positive consequential gain from caregiving.
Change in Dyadic Relationship Scale Caregiver Version Score
Time frame: Baseline, Post-intervention (up to 8 weeks)
The caregiver version of the Dyadic Relationship Scale includes 11 items which are responded to on a 4-point scale where 1 = strongly disagree and 4 = strongly agree. There are two subscales which assess dyadic strain (5 items) and positive dyadic interaction (6 items). Total scores for the dyadic strain subscale range from 5 to 20 and higher scores indicate greater levels of strain. Total scores for the positive dyadic interaction subscale range from 6 to 24 and higher scores indicate greater positive interactions.
Change in Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Time frame: Baseline, Post-intervention (up to 8 weeks)
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD.
Change in Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Time frame: Baseline, Post-intervention (up to 8 weeks)
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.
Observation During Worship Service
Time frame: Up to 8 weeks
For in person worship services, observations will focus on interactions within the dyads, interactions of caregivers with church leaders and members of the congregation, and interactions of the PLWD with church leaders and the congregation. For online worship services the observations will focus on interactions within the dyads, and the response to the service of the PLWD. Observations of actions during the worship services are assessed qualitatively and a summary score is not determined.
1 secondary outcome
Post-intervention Interview
Time frame: At the end of the intervention (up to 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be made available for sharing, after deidentification.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
Fayron Epps, PhD, RN principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia-friendly Worship Service in people with Dementia, run by Emory University 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 5 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 31 May 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Zarit Burden Inventory Score (time frame: Baseline, Post-intervention (up to 8 weeks)). The study lists 7 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 31 May 2022.