Faith-Based Toolbox for African Americans With Dementia

Study Overview
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Brief Summary
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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. A total of 60 people will take part in the intervention; 30 people with moderate and severe dementia and 30 family caregivers.

Detailed Description
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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 12 week program to test the feasibility and preliminary effectiveness of using Faith-HAT.

Official Title
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Creating a Faith-Based Toolbox for African Americans Living With Moderate and Severe Dementia

Conditions
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Alzheimer Disease, Dementia

Intervention / Treatment
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* Behavioral: Faith-based Home Activity Toolbox (Faith-HAT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caregivers<br>Caregivers of a person living with dementia will participate in the Faith-HAT intervention for 12 weeks. | Behavioral: Faith-based Home Activity Toolbox (Faith-HAT)<br>* 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.<br>|
| Experimental: Persons living with dementia<br>Persons living with dementia will participate in the Faith-HAT intervention for 12 weeks. | Behavioral: Faith-based Home Activity Toolbox (Faith-HAT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recruited within 12 months | Feasibility of the intervention will be assessed by how many months it takes to recruit all study participants. The researchers aim to complete recruitment within 12 months, enrolling 2-3 dyads per month. | Month 12 | 
| Frequency of Intervention Use | Engagement with the intervention will be assessed by the number of days per week that Faith-HAT was used by dyads during the 12 week intervention. | Month 15 | 
| Number of dyads completing the study | The feasibility of the intervention will be assessed by study retention, specifically, the number of dyads completing the study. | Month 15 | 
| Change in Zarit Burden Inventory Score | The amount of burden felt by caregivers will be 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. | Baseline, Week 12 | 
| Change in Perceived Stress Scale Score | Caregiver stress will be 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. | Baseline, Week 12 | 
| Change in 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. | Baseline, Week 12 | 
| Change in 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 to 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 and higher scores indicate greater difficulty with problem behaviors. | Baseline, Week 12 | 
| Change in Blood Pressure | Caregivers will wear ambulatory blood pressure monitors for 24 hours. Diastolic and systolic blood pressure will be measured. | Baseline, Week 12 | 
| Change in 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. | Baseline, Week 12 | 
| Change in 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. | Baseline, Week 12 | 
| Change in 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. | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Religion, Spirituality