Clinical trial NCT04325204: Faith-Based Toolbox for African Americans With Dementia
Official title: Creating a Faith-Based Toolbox for African Americans Living With Moderate and Severe Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Keywords: Religion
Spirituality
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-03-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Recruited Within the Goal of 12 Months
timeFrame: At enrollment (up to 21 months of study)
measure: Number of Participants Engaging in the Intervention at Least Two Days Per Week
timeFrame: Week 6
measure: Number of Dyads Completing the Study
timeFrame: Month 20 of the study
measure: Zarit Burden Inventory Score
timeFrame: Baseline, Week 6
measure: Perceived Stress Scale Score
timeFrame: Baseline, Week 6
measure: Center for Epidemiologic Studies - Depression (CES-D) Scale Score
timeFrame: Baseline, Week 6
measure: Revised Memory and Behavior Problem Checklist Score
timeFrame: Baseline, Week 6
measure: Medical Outcomes Study Sleep Scale (MOS-Sleep) Score
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Caregiver Heart Rate Variability Time Domain
timeFrame: Baseline, Week 6
measure: Caregiver Heart Rate Variability Frequency Domain
timeFrame: Baseline, Week 6
measure: Caregiver Skin Conductance Level (SCL)
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Fairburn
country: United States
facility: Emory University, Nell Hodgson Woodruff School of Nursing
state: Georgia
Study officials:
affiliation: Emory University
name: Fayron Epps, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: