Faith-Based Toolbox for African Americans With Dementia

NCT04325204 | Completed Results

• 2 other identifiers: IRB00115228K23AG065452
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia

Keywords

Religion; Spirituality

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  Baseline, Week 6

Secondary Outcomes (3)

• Caregiver Heart Rate Variability Time Domain

  Baseline, Week 6

• Caregiver Heart Rate Variability Frequency Domain

  Baseline, Week 6

• Caregiver Skin Conductance Level (SCL)

  Baseline, Week 6

Study Arms (2)

Caregivers

EXPERIMENTAL

Caregivers of a person living with dementia will participate in the Faith-HAT intervention for 6 weeks.

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.

Behavioral: Faith-based Home Activity Toolbox (Faith-HAT)

Interventions

Faith-based Home Activity Toolbox (Faith-HAT) BEHAVIORAL

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.

Caregivers; Persons living with dementia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• has active plans to move from under care of primary caregiver
• routinely attends church
• hostile to religion
• unwilling to engage in Faith-HAT

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Emory University, Nell Hodgson Woodruff School of Nursing

Fairburn, Georgia, 30213, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Fayron Epps, PhD, RN
• Organization: Emory University

fepps@emory.edu

404-727-6936

Study Officials

• Fayron Epps, PhD, RN

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 27, 2020
• Study Start: August 19, 2021
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available for sharing beginning 3 months and ending 5 years following article publication.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve aims in the approved proposal. Proposals should be directed to fepps@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website.

Locations

US (1)