Clinical trial NCT05772689: Caregiving While Black
Official title: Caregiving While Black: Optimizing Outcomes for Black Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Keywords: Caregiver of patients living with dementia
African-American caregivers
Black caregivers
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2023-03-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this project is to revise and test an online education program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness.

This study has two phases, and participants will take part in Phase 1 and/or Phase 2 of this study. Participants will take part in one and/or both phases in this study if they are a caregiver to a person living with dementia. Caregivers must self-identify as Black American and as the unpaid principal caregiver of a community-dwelling person living with a dementia illness and who is the principal companion of that person during healthcare encounters. Caregivers must also be 18 years of age or older and will be providing at least some hands-on care multiple times a week, if not daily. It is preferred that participants have access to and the ability to use broadband internet services to engage with the Caregiving While Black course. Participants should not have a plan in place to move the person living with a dementia illness to an institutional setting within the next six months.

Detailed description: Racial disparities and inequities substantially affect the situation Black dementia caregivers face and must understand, their self-assessed competence in handling the situation, and the coping strategies they deploy within it, all of which can contribute to - or lessen - emotional distress. The goal of this project is to establish the efficacy of the Caregiving while Black CWB) course which seeks to equip and empower Black dementia caregivers with the knowledge, skills, and sense of mastery they need to address and cope effectively within their role broadly, not just in the context of the pandemic. Researchers will conduct a two-arm clinical trial in which 140 Black caregivers will be randomly assigned to participate in Caregiving while Black or receive the program after a wait of 3 months. To do this, the research team will first employ an iterative, user-centered design approach and focus groups, to augment the prototype Caregiving while Black psychoeducation education course to include greater interactivity, access, usability, and active learning on the part of participating caregivers. Investigators will then assess the efficacy of the Caregiving while Black course in enhancing caregivers' sense of caregiving mastery, perceived ability to manage care recipients' behavioral and psychological symptoms, and improving their quality of life, health literacy, and emotional well-being.

The 140 caregiver participants will be enrolled in cohorts of 10. Researchers will use a two-arm design with participants randomly assigned on a 1:1 ratio to immediate participation in CWB (n = 70) and a usual care condition (n = 70). There will be three data-collection points evenly spaced across 6 months. Those in each cohort's intervention condition will take part in the Caregiving while Black course immediately following baseline data collection. Those in the usual care conditions will take part in Caregiving while Black after a delay of 3 months (following the 3-month data collection point). Caregiver participants will take part in the study for a total of 6 months between years (enrollment, interviews, and surveys). The research team will analyze data to determine changes in measures pre- and post-course. The investigators will also conduct qualitative interviews to guide further enhancements for broader implementation.

This project is the next step in establishing a scalable and effective culturally relevant psychoeducation education course to mitigate the effects of structural racism by supporting the practices of caregiving in the Black community.

Eligibility criteria: Caregiver Inclusion Criteria:

* 18 years or older
* family member (or friend) who self-identifies as Black American and as the principal caregiver of a community-dwelling person living with dementia (PLWD), (not in hospice care) and who is the principal companion of that person during healthcare encounters;
* provides some hands-on care multiple times a week;
* has access to an electronic device and/or access to broadband internet; and
* able to speak and understand English.
* Caregivers are not required to be co-located with the care recipient.

Exclusion Criteria:

* Those who cannot provide consent,
* are not yet adults (\<18 years of age),
* prisoners, cognitively impaired adults,
* has plans to relinquish caring responsibilities for PLWD or considering moving the PLWD to an institutional setting within the next 6 months, and
* who are not able to clearly understand English.

Primary outcomes:
measure: Efficacy of Caregiving while Black in enhancing caregivers' sense by assessing the change in Caregiver Mastery Score
timeFrame: Baseline, 10 weeks, and 6 months
Secondary outcomes:
measure: Perceived ability to manage recipients' behavioral and psychological symptoms (depression).
timeFrame: Baseline, 10 weeks, and 6 months
measure: Perceived ability to manage anxiety.
timeFrame: Baseline, 10 weeks, and 6 months
measure: Perceived ability to manage recipients' burden
timeFrame: Baseline, 10 weeks, and 6 months
measure: Perceived ability to manage recipients' stress
timeFrame: Baseline, 10 weeks, and 6 months
measure: Perceived ability to manage and improve recipient's health literacy
timeFrame: Baseline,10 weeks, and 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Fayron Epps, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: