Faith-Based Toolbox for African Americans With Dementia

NCT ID: NCT04325204

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-19
• Study Completion Date: 2023-07-13

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.

Conditions

Alzheimer Disease; Dementia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Caregivers

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

Group Type: EXPERIMENTAL

Faith-based Home Activity Toolbox (Faith-HAT)

Intervention Type: 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.

Persons living with dementia

Persons living with dementia will participate in the Faith-HAT intervention for 6 weeks.

Group Type: EXPERIMENTAL

Faith-based Home Activity Toolbox (Faith-HAT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Fayron Epps

Adjunct Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fayron Epps, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University, Nell Hodgson Woodruff School of Nursing

Fairburn, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K23AG065452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00115228

Identifier Type: -

Identifier Source: org_study_id