Faith-Based Toolbox for African Americans With Dementia

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325204
• Other study ID #: IRB00115228
• Secondary ID: K23AG065452
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: July 13, 2023

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 13, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Emory University, Nell Hodgson Woodruff School of Nursing	Fairburn	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 6 week intervention.	Month 15
Primary	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
Primary	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 6
Primary	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 6
Primary	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 6
Primary	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 6
Primary	Change in 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 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).	Baseline, Week 6
Primary	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. 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.	Baseline, Week 6
Primary	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. 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.	Baseline, Week 6
Primary	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. 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.	Baseline, Week 6