Caregiver Stress SyndromeCaRENCT04732715
Caregiving and Racial Considerations During a Pandemic Online Training Education
A study testing CaRE Course in people with Caregiver Stress Syndrome, run by Emory University at 1 site in United States.
Trial summary
The overall goal of this project is to develop and prototype-test a highly accessible program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness in a time of crisis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Stress Syndrome
- What is being tested?
- CaRE Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 31 Oct 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identify as Black American
- unpaid principal caregiver of a community-dwelling person living with a dementing illness and who is the principal companion of that person during healthcare encounters
- provide at least some hands-on care multiple times a week, if not daily
- access to and ability to use broadband internet services to engage with the CaRE Course
- not planning to move the person living with the dementing illness to an institutional setting within the next six months
Who cannot join
- cannot provide consent
- prisoners
- cognitively impaired adults
- not able to clearly understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CaRE Course: Caregiving and Racial Considerations During a Pandemic Online Training Education
The overall goal of this project is to develop and prototype-test a highly accessible program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness in a time of crisis. Participants will be asked a series of questions in a baseline interview, and then will be asked to partake in the CaRE course during a 6 to 8-week period.
Read the detailed description
Black Americans have over double the prevalence of Alzheimer's disease and related dementias (ADRD) compared to Whites, thus increasing the number of family members providing care for a person living with dementia (PLWD) within this racial/ethnic group. Black American caregivers typically deal with the complexities of caregiving through the lens of race and associated health disparities. Due to the centuries-old disadvantaged social history of Black Americans, a number of unique stressors, vulnerabilities, but also resources, have emerged which could inform and affect Black American dementia caregivers' experiences and well-being. There is overwhelming evidence that Black American caregivers and their care recipients experience disparities in care, have lower rates of formal service use, and are generally under-treated. Now in this seemingly worst of times with the coronavirus disease 2019 (COVID-19) pandemic, the disparities are more apparent: Black Americans (13.4% of the population according to the 2019 U.S. Census Bureau), account for approximately 25% of COVID-19 related deaths and are dying at a rate more than 1.5 times higher than their counterparts. The proposed CaRE Course is meant to address the cultural reality of caregiving while Black - not just during the pandemic, but beyond. The program seeks to develop caregiving mastery while and by understanding, acknowledging, and addressing the influence of race, culture, and disparities on caregivers' mental health, and their medical, spiritual, and safety needs.
The researchers will first establish a preliminary competency-based course curriculum storyboard of 40-50 modules and draft scripts for the instructional videos that will anchor the CaRE course, through iterative Design Studio sessions with Black faith and community leaders, Black American caregivers, course faculty, COVID-19 specialists, dementia experts, and other clinical experts and working with Emory Nursing Experience instructional designers. Then, partnering with a variety of faith-based and community organizations and others, the researchers will identify a sample of Black American caregivers who will be invited to enroll in the CaRE Course and participate in formative and summative research related to its usability, salience, and preliminary efficacy.
- Conditions
- Caregiver Stress Syndrome
- Being tested
- CaRE Course
- Keywords
- Disparities, Black American Caregivers, Dementia Caregiving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaRE CourseBehavioural
Participants will complete the CaRE Course over a 6-8 week time period. The curriculum of the CaRE course will include topics addressing caregiving for a PLWD during a pandemic, navigating the healthcare system for a PLWD, guiding and managing daily life, and self care.
| Study group | Role | What they receive |
|---|---|---|
| CaRE Course | Experimental | Black American caregivers of PLWD will participate in the CaRE Course. Receives: Behavioral: CaRE Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cultural Justification for Caregiving Scale Score
The Cultural Justification for Caregiving Scale is a 10-item self-report assessing the cultural reasons for the caregivers providing care. Responses are given on a 4-point scale where 1 = strongly disagree and 4 = strongly agree. Total scores range from 10 to 40 with higher scores indicating greater cultural influences for providing care.
Measured: Baseline, Week 10, Week 18
Change in Center for Epidemiologic Studies (CES)-Depression Scale Score
The CES - Depression scale is a 20-item self-report instrument assessing how often symptoms of depression have been experienced in the last week. 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, Week 10, Week 18
Change in State-Trait Anxiety Inventory (STAI) Y Form Score
The STAI Y Form 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 where higher scores indicate greater anxiety.
Measured: Baseline, Week 10, Week 18
Change in Perceived Stress Scale Score
The Perceived Stress Scale is a14-item scale assessing the caregivers' feelings and thoughts during the past month. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
Measured: Baseline, Week 10, Week 18
Change in Revised Memory and Behavior Problem Checklist (RMBPC) Score
The RMBPC is a 24-item scale assessing the frequency of problems that persons with dementia often have as well as how much these behaviors bothered the caregiver. Caregiver reactions are assessed on a 5-point scale where 0 = not at all upset and 4 = extremely upset. Total scores range from 0 to 96 where higher scores indicate greater caregiver distress in reaction to problem behaviors.
Measured: Baseline, Week 10, Week 18
Change in Zarit Burden Interview Score
The Zarit Burden Interview is a 22-item instrument assessing 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 by being a caregiver.
Measured: Baseline, Week 10, Week 18
Change in Caregiver Mastery Score
The Caregiver Mastery instrument includes 14-items assessing feelings experienced as a result of being a caregiver to a person with dementia. The instrument includes categories of relational deprivation, caregiving competence, and management of situations. Responses are given on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 14 to 56, where higher scores indicate feeling a greater sense of mastery of caregiving.
Measured: Baseline, Week 10, Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start25 Oct 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Stress SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation
- Responsible party
- Principal investigator, Fayron Epps, Emory University
- Investigators
- Fayron Epps, PhD, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732715
- Sponsor's protocol ID
- STUDY00002078
- Acronym
- CaRE
- Status last verified
- Nov 2022
- First submitted
- 27 Jan 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial will be made available for sharing, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CaRE Course: Caregiving and Racial Considerations During a Pandemic Online Training Education
- ClinicalTrials.gov ID
- NCT04732715
- Acronym / sponsor ID
- CaRE / STUDY00002078
- Conditions
- Caregiver Stress Syndrome
- Keywords
- Disparities, Black American Caregivers, Dementia Caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Retirement Research Foundation
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 1 Feb 2021 (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 overall goal of this project is to develop and prototype-test a highly accessible program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness in a time of crisis. Participants will be asked a series of questions in a baseline interview, and then will be asked to partake in the CaRE course during a 6 to 8-week period.
Detailed description
Black Americans have over double the prevalence of Alzheimer's disease and related dementias (ADRD) compared to Whites, thus increasing the number of family members providing care for a person living with dementia (PLWD) within this racial/ethnic group. Black American caregivers typically deal with the complexities of caregiving through the lens of race and associated health disparities. Due to the centuries-old disadvantaged social history of Black Americans, a number of unique stressors, vulnerabilities, but also resources, have emerged which could inform and affect Black American dementia caregivers' experiences and well-being. There is overwhelming evidence that Black American caregivers and their care recipients experience disparities in care, have lower rates of formal service use, and are generally under-treated. Now in this seemingly worst of times with the coronavirus disease 2019 (COVID-19) pandemic, the disparities are more apparent: Black Americans (13.4% of the population according to the 2019 U.S. Census Bureau), account for approximately 25% of COVID-19 related deaths and are dying at a rate more than 1.5 times higher than their counterparts. The proposed CaRE Course is meant to address the cultural reality of caregiving while Black - not just during the pandemic, but beyond. The program seeks to develop caregiving mastery while and by understanding, acknowledging, and addressing the influence of race, culture, and disparities on caregivers' mental health, and their medical, spiritual, and safety needs.
The researchers will first establish a preliminary competency-based course curriculum storyboard of 40-50 modules and draft scripts for the instructional videos that will anchor the CaRE course, through iterative Design Studio sessions with Black faith and community leaders, Black American caregivers, course faculty, COVID-19 specialists, dementia experts, and other clinical experts and working with Emory Nursing Experience instructional designers. Then, partnering with a variety of faith-based and community organizations and others, the researchers will identify a sample of Black American caregivers who will be invited to enroll in the CaRE Course and participate in formative and summative research related to its usability, salience, and preliminary efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CaRE Course | Experimental | Behavioral: CaRE CourseBlack American caregivers of PLWD will participate in the CaRE Course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-identify as Black American
- unpaid principal caregiver of a community-dwelling person living with a dementing illness and who is the principal companion of that person during healthcare encounters
- provide at least some hands-on care multiple times a week, if not daily
- access to and ability to use broadband internet services to engage with the CaRE Course
- not planning to move the person living with the dementing illness to an institutional setting within the next six months
Key exclusion criteria (4 listed)
- cannot provide consent
- prisoners
- cognitively impaired adults
- 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 |
|---|---|---|
| CaRE CourseParticipants will complete the CaRE Course over a 6-8 week time period. The curriculum of the CaRE course will include topics addressing caregiving for a PLWD during a pandemic, navigating the healthcare system for a PLWD, guiding and managing daily life, and self care. | Behavioural | CaRE Course |
Primary outcome
Change in Cultural Justification for Caregiving Scale Score
Time frame: Baseline, Week 10, Week 18
The Cultural Justification for Caregiving Scale is a 10-item self-report assessing the cultural reasons for the caregivers providing care. Responses are given on a 4-point scale where 1 = strongly disagree and 4 = strongly agree. Total scores range from 10 to 40 with higher scores indicating greater cultural influences for providing care.
Change in Center for Epidemiologic Studies (CES)-Depression Scale Score
Time frame: Baseline, Week 10, Week 18
The CES - Depression scale is a 20-item self-report instrument assessing how often symptoms of depression have been experienced in the last week. 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.
Change in State-Trait Anxiety Inventory (STAI) Y Form Score
Time frame: Baseline, Week 10, Week 18
The STAI Y Form 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 where higher scores indicate greater anxiety.
Change in Perceived Stress Scale Score
Time frame: Baseline, Week 10, Week 18
The Perceived Stress Scale is a14-item scale assessing the caregivers' feelings and thoughts during the past month. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 40 where higher scores indicate greater perceived stress.
Change in Revised Memory and Behavior Problem Checklist (RMBPC) Score
Time frame: Baseline, Week 10, Week 18
The RMBPC is a 24-item scale assessing the frequency of problems that persons with dementia often have as well as how much these behaviors bothered the caregiver. Caregiver reactions are assessed on a 5-point scale where 0 = not at all upset and 4 = extremely upset. Total scores range from 0 to 96 where higher scores indicate greater caregiver distress in reaction to problem behaviors.
Change in Zarit Burden Interview Score
Time frame: Baseline, Week 10, Week 18
The Zarit Burden Interview is a 22-item instrument assessing 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 by being a caregiver.
Change in Caregiver Mastery Score
Time frame: Baseline, Week 10, Week 18
The Caregiver Mastery instrument includes 14-items assessing feelings experienced as a result of being a caregiver to a person with dementia. The instrument includes categories of relational deprivation, caregiving competence, and management of situations. Responses are given on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 14 to 56, where higher scores indicate feeling a greater sense of mastery of caregiving.
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 10 Nov 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial will be made available for sharing, after deidentification.
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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 CaRE Course in people with Caregiver Stress Syndrome, 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 5 inclusion and 4 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 10 Nov 2022. 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?
Change in Cultural Justification for Caregiving Scale Score (time frame: Baseline, Week 10, Week 18). The study lists 7 primary outcomes in all. 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 10 Nov 2022.