Alzheimer DiseaseNCT04325204
Faith-Based Toolbox for African Americans With Dementia
A study testing Faith-based Home Activity Toolbox (Faith-HAT) in people with Alzheimer Disease and Dementia, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to create and test faith-based activities that might be useful for African American adults with moderate and severe dementia and their caregivers. The study aims to enroll 30 dyads of people with moderate and severe dementia and their family caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Faith-based Home Activity Toolbox (Faith-HAT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 13 Jul 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Caregiver Inclusion Criteria:
- at least 18 years of age
- reside with and care for (average of 4 hours/per day of unpaid assistance) for a family or friend experiencing signs and symptoms of moderate or severe ADRD as indicated through self-report or family caregiver report
- able to read, speak, and understand English
- cognitively intact
- access to a wireless internet connection (wi-fi)
- access to a phone or mobile device that accepts text messages
PLWD Inclusion Criteria:
- community-dwelling experiencing signs and symptoms of moderate or severe ADRD through self-report or family caregiver report
- has a family caregiver that resides with them and is willing to participate
- no plan for institutionalization in the next month
- history of participating in private or public religious activities
- understands English (toolbox activities will be produced in English)
- family and self-reporting of the level of cognitive impairment identified according to the signs and symptoms of moderate and severe ADRD associated with the Alzheimer's Association16 categorization of moderate/middle, and severe/late stages of dementia
Caregiver Exclusion Criteria:
- does not have a history of participating in private or public religious activities
- hostile to PLWD religious expression
- has active plans to move to another residence without family member with ADRD
PLWD Exclusion Criteria:
- has active plans to move from under care of primary caregiver
- routinely attends church
- hostile to religion
- unwilling to engage in Faith-HAT
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Nell Hodgson Woodruff School of Nursing
Fairburn, Georgia, 30213
About this study
Official title: Creating a Faith-Based Toolbox for African Americans Living With Moderate and Severe Dementia
The purpose of this study is to create and test faith-based activities that might be useful for African American adults with moderate and severe dementia and their caregivers. The study aims to enroll 30 dyads of people with moderate and severe dementia and their family caregivers.
Read the detailed description
African Americans (AAs) are more likely than other racial/ethnic groups to be diagnosed with Alzheimer's disease and related dementias (ADRD) and will account for 20% of persons living with dementia (PLWD) by 2050. PLWD experience progressive distress and confusion, which decreases their quality of life and also contributes to the emotional strain, burden, social isolation, and depression experienced by caregivers. Research indicates that religiosity (the inner commitment to one's faith through integration of religious beliefs and practices into one's life) can serve as a protective factor against the stressors associated with caregiving and living with ADRD.
The goal of this clinical feasibility trial and NIH stage 1 intervention development project is to go beyond the four walls of the church to find ways to meet the spiritual needs of persons living with moderate and severe ADRD "where they are" in order to help them remain religiously and spiritually engaged. This study is premised on the notion that religious/spiritual engagement is possible and beneficial for PLWD and that this beneficial effect will extend to their caregivers.
The purpose of this project is to design and test the feasibility of employing components of a Faith-based Home Activity Toolbox (Faith-HAT) and create intervention tools for a full-scale randomized controlled trial (RCT) to test the efficacy-effectiveness of faith-based programs on patient and caregiver outcomes.
Thirty dyads of people with dementia and their caregivers will be enrolled in a 6 week program to test the feasibility and preliminary effectiveness of using Faith-HAT. A final study follow-up assessment occurs 6 weeks after the end of the intervention.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Faith-based Home Activity Toolbox (Faith-HAT)
- Keywords
- Religion, Spirituality
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faith-based Home Activity Toolbox (Faith-HAT)Behavioural
They will select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons.
Faith-HAT will be placed on online, which requires little technical know-how by users. The PI will provide training to participants on how to use the Faith-HAT and online diary on the tablet computer provided by the project.
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | Experimental | Caregivers of a person living with dementia will participate in the Faith-HAT intervention for 6 weeks. Receives: Behavioral: Faith-based Home Activity Toolbox (Faith-HAT) |
| Persons living with dementia | Experimental | Persons living with dementia will participate in the Faith-HAT intervention for 6 weeks. Receives: Behavioral: Faith-based Home Activity Toolbox (Faith-HAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Recruited Within the Goal of 12 Months
Feasibility of the intervention is assessed by how many months it takes to recruit all study participants. The researchers aimed to complete recruitment within 12 months, enrolling 2 to 3 dyads per month.
Measured: At enrollment (up to 21 months of study)
Number of Participants Engaging in the Intervention at Least Two Days Per Week
Engagement with the intervention is assessed by the number of participants who reported engaging with Faith-HAT at least two days per week during the 6 week intervention.
Measured: Week 6
Number of Dyads Completing the Study
The feasibility of the intervention is assessed by study retention, specifically, the number of dyads completing the study.
Measured: Month 20 of the study
Zarit Burden Inventory Score
The amount of burden felt by caregivers was assessed with the 22-item Zarit Burden Inventory. Responses are given on a scale from 0 to 4 where for 0 = never and 4 = nearly always. Total scores range from 0 to 88, where higher scores indicate greater feelings of caregiver burden.
Measured: Baseline, Week 6
Perceived Stress Scale Score
Caregiver stress was assessed with the 14-item Perceived Stress Scale. Responses are given on a scale of 0 to 4 where 0 = never and 4 = very often. Total scores range from 0 to 56 with higher scores indicating greater perceived stress by caregivers.
Measured: Baseline, Week 6
Center for Epidemiologic Studies - Depression (CES-D) Scale Score
Caregiver depression will be assessed with the 20-item Center for Epidemiologic Studies - Depression Scale. Caregivers are asked how frequently they have experienced specific symptoms of depression in the past week. Responses are given as 0 = rarely, 1 = 1-2 days, 2 = 3-4 days, and 4 = 5-7 days. Total scores range from 0 to 80 with higher scores indicating greater symptoms of depression.
Measured: Baseline, Week 6
Revised Memory and Behavior Problem Checklist Score
The Revised Memory and Behavior Problem Checklist assesses the presence of problematic behaviors in persons with dementia as well as caregiver distress due to those problems. Caregivers complete the 24-item instrument by indicating whether or not the behavior has occurred and how distressing the behaviors are for them on a scale from 0 to 4 (where 0 = not at all and 4 = extremely). Total scores assessing caregiver reactions to problem behaviors range from 0 to 96 with higher scores indicating greater difficulty with problem behaviors.
Measured: Baseline, Week 6
Medical Outcomes Study Sleep Scale (MOS-Sleep) Score
The Medical Outcomes Study Sleep Scale (MOS-Sleep) measures sleep quality in the past four weeks. The MOS-Sleep includes 12 items assessing the dimensions of sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Nine of the 12 items are used to create a sleep problem index. Scores for each of the dimensions and the sleep problem index are converted to a 0 to 100 scale, where higher scores indicate more of the dimension attribute or increased problems with sleep (for the sleep problem index).
Measured: Baseline, Week 6
Secondary outcomes (3)
Caregiver Heart Rate Variability Time Domain
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the time domain of heart rate variability. Mean peak-to-peak intervals will be assessed in seconds. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Measured: Baseline, Week 6
Caregiver Heart Rate Variability Frequency Domain
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of the frequency domain, measured in Hertz (Hz), of heart rate variability. Parasympathetic control is characterized as high frequency (0.15-0.40 Hz) while low frequency (0.04-0.15 Hz) characterizes both the sympathetic and parasympathetic activities. Exposure of an individual to a physical or mental stressor activates their stress response through the sympathetic nervous system (SNS) axis. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Measured: Baseline, Week 6
Caregiver Skin Conductance Level (SCL)
Caregivers will wear wristband, a wearable-sensor (E4 wristwatch), that detects stress reactivity in an ecologically appropriate setting (to overcome the artificial setting of the clinical site) to collect longer-duration measurement of skin conductance level. Skin conductance level is the electrical conductivity of the skin. Skin conducts electricity better during physiological or psychological arousal, making skin conductance level a maker for measuring emotion. Caregiver participants will be asked to wear the wristband for 24 hours, prior to starting the intervention and again at the end of the intervention.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start19 Aug 2021
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
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 Alzheimer DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Fayron Epps, Emory University
- Investigators
- Fayron Epps, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325204
- Sponsor's protocol ID
- IRB00115228
- Other IDs
- K23AG065452
- Status last verified
- Sep 2024
- First submitted
- 26 Mar 2020
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 available for sharing, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Faith-Based Toolbox for African Americans Living With Moderate and Severe Dementia
- ClinicalTrials.gov ID
- NCT04325204
- Acronym / sponsor ID
- IRB00115228
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Religion, Spirituality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Posted 8 Oct 2024
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 study is to create and test faith-based activities that might be useful for African American adults with moderate and severe dementia and their caregivers. The study aims to enroll 30 dyads of people with moderate and severe dementia and their family caregivers.
Detailed description
African Americans (AAs) are more likely than other racial/ethnic groups to be diagnosed with Alzheimer's disease and related dementias (ADRD) and will account for 20% of persons living with dementia (PLWD) by 2050. PLWD experience progressive distress and confusion, which decreases their quality of life and also contributes to the emotional strain, burden, social isolation, and depression experienced by caregivers. Research indicates that religiosity (the inner commitment to one's faith through integration of religious beliefs and practices into one's life) can serve as a protective factor against the stressors associated with caregiving and living with ADRD.
The goal of this clinical feasibility trial and NIH stage 1 intervention development project is to go beyond the four walls of the church to find ways to meet the spiritual needs of persons living with moderate and severe ADRD "where they are" in order to help them remain religiously and spiritually engaged. This study is premised on the notion that religious/spiritual engagement is possible and beneficial for PLWD and that this beneficial effect will extend to their caregivers.
The purpose of this project is to design and test the feasibility of employing components of a Faith-based Home Activity Toolbox (Faith-HAT) and create intervention tools for a full-scale randomized controlled trial (RCT) to test the efficacy-effectiveness of faith-based programs on patient and caregiver outcomes.
Thirty dyads of people with dementia and their caregivers will be enrolled in a 6 week program to test the feasibility and preliminary effectiveness of using Faith-HAT. A final study follow-up assessment occurs 6 weeks after the end of the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caregivers | Experimental | Behavioral: Faith-based Home Activity Toolbox (Faith-HAT)Caregivers of a person living with dementia will participate in the Faith-HAT intervention for 6 weeks. |
| Persons living with dementia | Experimental | Behavioral: Faith-based Home Activity Toolbox (Faith-HAT)Persons living with dementia will participate in the Faith-HAT intervention for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Faith-based Home Activity Toolbox (Faith-HAT)They will select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons. Faith-HAT will be placed on online, which requires little technical know-how by users. The PI will provide training to participants on how to use the Faith-HAT and online diary on the tablet computer provided by the project. | Behavioural | Caregivers, Persons living with dementia |
Primary outcome
Number of Participants Recruited Within the Goal of 12 Months
Time frame: At enrollment (up to 21 months of study)
Feasibility of the intervention is assessed by how many months it takes to recruit all study participants. The researchers aimed to complete recruitment within 12 months, enrolling 2 to 3 dyads per month.
Number of Participants Engaging in the Intervention at Least Two Days Per Week
Time frame: Week 6
Engagement with the intervention is assessed by the number of participants who reported engaging with Faith-HAT at least two days per week during the 6 week intervention.
Number of Dyads Completing the Study
Time frame: Month 20 of the study
The feasibility of the intervention is assessed by study retention, specifically, the number of dyads completing the study.
Zarit Burden Inventory Score
Time frame: Baseline, Week 6
The amount of burden felt by caregivers was assessed with the 22-item Zarit Burden Inventory. Responses are given on a scale from 0 to 4 where for 0 = never and 4 = nearly always. Total scores range from 0 to 88, where higher scores indicate greater feelings of caregiver burden.
Perceived Stress Scale Score
Time frame: Baseline, Week 6
Caregiver stress was assessed with the 14-item Perceived Stress Scale. Responses are given on a scale of 0 to 4 where 0 = never and 4 = very often. Total scores range from 0 to 56 with higher scores indicating greater perceived stress by caregivers.
Center for Epidemiologic Studies - Depression (CES-D) Scale Score
Time frame: Baseline, Week 6
Caregiver depression will be assessed with the 20-item Center for Epidemiologic Studies - Depression Scale. Caregivers are asked how frequently they have experienced specific symptoms of depression in the past week. Responses are given as 0 = rarely, 1 = 1-2 days, 2 = 3-4 days, and 4 = 5-7 days. Total scores range from 0 to 80 with higher scores indicating greater symptoms of depression.
Revised Memory and Behavior Problem Checklist Score
Time frame: Baseline, Week 6
The Revised Memory and Behavior Problem Checklist assesses the presence of problematic behaviors in persons with dementia as well as caregiver distress due to those problems. Caregivers complete the 24-item instrument by indicating whether or not the behavior has occurred and how distressing the behaviors are for them on a scale from 0 to 4 (where 0 = not at all and 4 = extremely). Total scores assessing caregiver reactions to problem behaviors range from 0 to 96 with higher scores indicating greater difficulty with problem behaviors.
Medical Outcomes Study Sleep Scale (MOS-Sleep) Score
Time frame: Baseline, Week 6
The Medical Outcomes Study Sleep Scale (MOS-Sleep) measures sleep quality in the past four weeks. The MOS-Sleep includes 12 items assessing the dimensions of sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Nine of the 12 items are used to create a sleep problem index. Scores for each of the dimensions and the sleep problem index are converted to a 0 to 100 scale, where higher scores indicate more of the dimension attribute or increased problems with sleep (for the sleep problem index).
3 secondary outcomes
Caregiver Heart Rate Variability Time Domain
Time frame: Baseline, Week 6
Caregiver Heart Rate Variability Frequency Domain
Time frame: Baseline, Week 6
Caregiver Skin Conductance Level (SCL)
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be available for sharing, after deidentification.
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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.
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 Faith-based Home Activity Toolbox (Faith-HAT) in people with Alzheimer Disease and 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?
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 8 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). 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 Recruited Within the Goal of 12 Months (time frame: At enrollment (up to 21 months of study)). The study lists 8 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 8 Oct 2024.