Caregiving While Black: LIVE

NCT06605391 | Completed Results

• 2 other identifiers: STUDY00005946R21AG083366
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the psychoeducation course, Caregiving while Black - Learning In Vital Engagement (LIVE), among Black caregivers providing care to persons with dementia. This course aims to enhance Black caregivers' capacity to cope effectively with their caregiving role of navigating care and the world of healthcare in ways that take into consideration the social and cultural context of their unique life experiences.

Conditions

Dementia

Keywords

Caregiving

Outcome Measures

Primary Outcomes (12)

• Health Literacy Questionnaire (HLQ) Score for Feeling Understood by Healthcare Providers Subscale

  The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Feeling understood and supported by healthcare providers" has 4 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses and ranges from 1 to 4. Higher scores indicate that the subscale is an area of health literacy strength.

  Baseline, Month 3, Month 6

• Health Literacy Questionnaire (HLQ) Score for Appraisal of Health Information Subscale

  The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Appraisal of health information" has 5 items where responses are given on a 4-point scale from "strongly disagree" (scored as 1) to "strongly agree" (scored as 4). The total score for this subscale is the average of responses and ranges from 1 to 4. Higher scores indicate that the subscale is an area of health literacy strength.

  Baseline, Month 3, Month 6

• Health Literacy Questionnaire (HLQ) Score for Ability to Engage With Healthcare Providers Subscale

  The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Ability to actively engage with healthcare providers" has 5 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.

  Baseline, Month 3, Month 6

• Health Literacy Questionnaire (HLQ) Score for Navigating the Healthcare System Subscale

  The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Navigating the healthcare system" has 6 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.

  Baseline, Month 3, Month 6

• Health Literacy Questionnaire (HLQ) Score for Ability to Find Information Subscale

  The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Ability to find good health information" has 5 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.

  Baseline, Month 3, Month 6

• Health Literacy Questionnaire (HLQ) Score for Understand Health Information Subscale

  The Health Literacy Questionnaire assesses multiple dimensions of health literacy with 9 subscales. The subscale of "Understand health information well enough to know what to do" has 5 items where responses are given on a 5-point scale from "cannot do" (scored as 1) to "very easy" (scored as 5). The total score for this subscale is the average of responses and ranges from 1 to 5. Higher scores indicate that the subscale is an area of health literacy strength.

  Baseline, Month 3, Month 6

• Zarit Burden Inventory (ZBI) Score

  The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.

  Baseline, Month 3, Month 6

• Center for Epidemiological Studies - Depression 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 60 with higher scores indicating greater symptoms of depression.

  Baseline, Month 3, Month 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, Month 3, Month 6

• State-Trait Anxiety Inventory (STAI) Score

  The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.

  Baseline, Month 3, Month 6

• Caregiver Assessment of Behavioral Skill Score

  The Caregiver Assessment of Behavioral Skill instrument includes 17 items asking how frequently caregivers respond to certain situations. Responses are given on a 3-point scale where "seldom true" is scored as 0 and "true most of the time" is scored as 2 (a response is also available when the situation is not relevant). The total score is is the sum of item ratings and ranges from 0 to 34, where higher scores indicate greater behavioral skills as related to caregiving.

  Baseline, Month 3, Month 6

• Pearlin Competence and Management of Situation Score

  Self-rated caregiving competency is assessed with 4 items asking about feelings the caregiver has as a result of providing care. Responses are given on a 4-point scale where "not at all" is scored as 1 and "completely" or "very" is scored as 4. The total score ranges from 4 to 16 with higher scores indicating greater feelings of competency.

  Baseline, Month 3, Month 6

Other Outcomes (3)

• Change in Health Literacy Questionnaire (HLQ) Score for Social Support Subscale

  Baseline, Month 3, Month 6

• Change in Health Literacy Questionnaire (HLQ) Score for Actively Managing Health Subscale

  Baseline, Month 3, Month 6

• Change in Health Literacy Questionnaire (HLQ) Score for Having Sufficient Information Subscale

  Baseline, Month 3, Month 6

Study Arms (1)

Caregiving While Black-LIVE

EXPERIMENTAL

Black dementia caregivers participating in the psychoeducation course, Caregiving while Black-LIVE, over an 8 week time period.

Behavioral: Caregiving While Black-LIVE

Interventions

Caregiving While Black-LIVE BEHAVIORAL

Caregiving while Black-LIVE is a psychoeducation program that aims to intensify the development of caregiver mastery by integrating the online learning assets of the fully asynchronous Caregiving while Black program with synchronous, group-based opportunities for interactivity and active learning. The Caregiving while Black course includes topics of navigating the healthcare system, managing home life, and caregiver self-care. Once enrolled in the course, participants will be provided instructions for accessing the weekly sessions and course online, and supplemental course materials will be mailed to them. The Canvas platform enables the research team to monitor each individual's movement in the cohort through the asynchronous part of the course. Nudges and reminders to view these materials are sent twice a week via text or email with participant's consent. Synchronous sessions are conducted on a videoconferencing platform.

Caregiving While Black-LIVE

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
• family member (or friend) who self-identifies as Black American and as the principal caregiver of a community-dwelling 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
• able to speak and understand English

You may not qualify if:

• persons who cannot provide consent
• persons who are not yet adults (under 18 years of age)
• prisoners
• cognitively impaired adults
• have plans to relinquish caring responsibilities for PLWD or are considering moving the PLWD to an institutional setting within the next 6 months
• not able to clearly understand English

Sponsors & Collaborators

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

Study Sites (1)

Emory University, Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

fepps@emory.edu

678-723-8188

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: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: October 1, 2024
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: September 23, 2025
• Results First Posted: September 23, 2025

Record last verified: 2025-09

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 publication of findings from this study in a scientific journal.
• Access Criteria: Data will be available for sharing with researchers who provide a methodologically sound proposal, for the purposes of achieving the 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)