Caregiver BurdenNCT05772689
Caregiving While Black
A study testing Caring While Black in people with Caregiver Burden, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Caring While Black
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caregiving While Black: Optimizing Outcomes for Black Dementia Caregivers
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.
Read the 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.
- Conditions
- Caregiver Burden
- Being tested
- Usual Care, Caring While Black
- Keywords
- Caregiver of patients living with dementia, African-American caregivers, Black caregivers
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Also called Standard of Care
Caregivers assigned to the usual care group will be enrolled in the course at the 3-month mark after consenting. All caregivers will then participate in quantitative interviews at post- 6months of their baseline
Caring While BlackOther
Also called Self-paced asynchronous online course
Caregivers assigned to this group will receive a schedule for their completion of the course over the next 2 months and supplemental course materials through the mail. The Canvas platform will enable the course to monitor everyone's movement in the cohort through the asynchronous part of the course. Nudges and reminders will be sent twice a week via text or email with the participant's consent.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Standard of Care Receives: Other: Usual Care |
| Caregiving while Black | Experimental | Caregivers of PLWD taking part in a fully self-paced asynchronous online caregiver education program. Receives: Other: Caring While Black |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Caregiving while Black in enhancing caregivers' sense by assessing the change in Caregiver Mastery Score
Participants will complete the Caregiver Mastery questionnaire. A 3 3-5 item scale of caregiver mastery of caregiving situations, indicating the extent to which respondents agree (5) or disagree (1) with each item. The instrument includes categories of relational deprivation, caregiving competence, and management of situations. Total scores range from 14 to 56, where higher scores indicate feeling a greater sense of mastery of caregiving.
Measured: Baseline, 10 weeks, and 6 months
Secondary outcomes (5)
Perceived ability to manage recipients' behavioral and psychological symptoms (depression).
Participants will complete the Center for Epidemiological Studies-Depression (CES-D) questionnaire. A 21-item self-report depression scale that asks caregivers to rate how often over the past week they experienced symptoms associated with depression. For this study, responses are given on a 4-point scale where 1 = rarely or none of the time and 4 = most or all of the time. Total scores range from 20 to 80 where higher scores indicate greater caregiver depression.
Measured: Baseline, 10 weeks, and 6 months
Perceived ability to manage anxiety.
Participants will complete the State-Trait Anxiety Inventory (STAI) questionnaire. A 20-item self-report scale of positive and negative anxiety experiences). All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
Measured: Baseline, 10 weeks, and 6 months
Perceived ability to manage recipients' burden
Participants will complete the Zarit Burden Scale. A 22-item scale of objective and subjective caregiver burden. Each item on the interview is a statement that the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened by being a caregiver.
Measured: Baseline, 10 weeks, and 6 months
Perceived ability to manage recipients' stress
Participants will complete the Perceived Stress questionnaire. A 14-item scale of self-reported caregiving stress. The questions in the perceived stress scale (PSS) ask about participants' feelings and thoughts during the last month. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline, 10 weeks, and 6 months
Perceived ability to manage and improve recipient's health literacy
Participants will complete health literacy questionnaires (18-item-9 subscales of self-report health literacy). Each sub-scale efficiently measures one of nine aspects of health literacy (each subscale with 4 to 6 items). One of the sub-scales measures Functional Health Literacy. It also measures eight other elements needed to measure the full construct of health literacy.
Measured: Baseline,10 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start6 May 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Principal investigator, Fayron Epps, Emory University
- Investigators
- Fayron Epps, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772689
- Sponsor's protocol ID
- STUDY00004305
- Other IDs
- 2025P010443
- Status last verified
- May 2026
- First submitted
- 23 Feb 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research team will share all deidentified individual participant data collected during the trial, with researchers who provide a methodologically sound proposal to achieve the aims described in the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiving While Black: Optimizing Outcomes for Black Dementia Caregivers
- ClinicalTrials.gov ID
- NCT05772689
- Acronym / sponsor ID
- STUDY00004305
- Conditions
- Caregiver Burden
- Keywords
- Caregiver of patients living with dementia, African-American caregivers, Black caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 6 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareStandard of Care |
| Caregiving while Black | Experimental | Other: Caring While BlackCaregivers of PLWD taking part in a fully self-paced asynchronous online caregiver education program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareAlso: Standard of CareCaregivers assigned to the usual care group will be enrolled in the course at the 3-month mark after consenting. All caregivers will then participate in quantitative interviews at post- 6months of their baseline | Other | Usual Care |
| Caring While BlackAlso: Self-paced asynchronous online courseCaregivers assigned to this group will receive a schedule for their completion of the course over the next 2 months and supplemental course materials through the mail. The Canvas platform will enable the course to monitor everyone's movement in the cohort through the asynchronous part of the course. Nudges and reminders will be sent twice a week via text or email with the participant's consent. | Other | Caregiving while Black |
Primary outcome
Efficacy of Caregiving while Black in enhancing caregivers' sense by assessing the change in Caregiver Mastery Score
Time frame: Baseline, 10 weeks, and 6 months
Participants will complete the Caregiver Mastery questionnaire. A 3 3-5 item scale of caregiver mastery of caregiving situations, indicating the extent to which respondents agree (5) or disagree (1) with each item. The instrument includes categories of relational deprivation, caregiving competence, and management of situations. Total scores range from 14 to 56, where higher scores indicate feeling a greater sense of mastery of caregiving.
5 secondary outcomes
Perceived ability to manage recipients' behavioral and psychological symptoms (depression).
Time frame: Baseline, 10 weeks, and 6 months
Perceived ability to manage anxiety.
Time frame: Baseline, 10 weeks, and 6 months
Perceived ability to manage recipients' burden
Time frame: Baseline, 10 weeks, and 6 months
Perceived ability to manage recipients' stress
Time frame: Baseline, 10 weeks, and 6 months
Perceived ability to manage and improve recipient's health literacy
Time frame: Baseline,10 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Yes. The research team will share all deidentified individual participant data collected during the trial, with researchers who provide a methodologically sound proposal to achieve the aims described in the approved proposal.
Related trials for Caregiver Burden
Not yet recruiting
VICA: A Virtual Care Assistant for Dementia Caregivers
Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
Recruiting
Medical Payment Case Management for Financial Toxicity in Patients With Primary Bone Tumors: A Randomized Controlled Trial
Bone Tumor, Bone Cancer
Recruiting
Applying CSNAT in HBPC as an Approach to Elder Mistreatment Risk Reduction
Caregiver Stress, Caregiver Health Related QOL
Not yet recruiting
Effect of Artificial Intelligent-based Training and Benson Relaxation Exercises on Caregiver Burden and Stress Levels in Caregivers of Patients With Parkinson's Disease
PARKINSON DISEASE (Disorder), Caregiver Burden
Recruiting
Leveraging Interventions for Caregiver Growth, Health, Training, Empowerment and Navigation: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain
Elevated Caregiver Strain, Dementia Caregiver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fayron Epps, PhD, RN principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring While Black in people with Caregiver Burden, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Caregiving while Black in enhancing caregivers' sense by assessing the change in Caregiver Mastery Score (time frame: Baseline, 10 weeks, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.