DementiaEICNCT04394260
Equality in Caregiving: Facilitating Caregiver Mastery Among LGBT Caregivers of PLWD
An observational study of Dementia and Caregiver Burnout, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to adapt existing Savvy Caregiving Program (SCP) for lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD). After watching the SCP Remote Learning videos, participants will attend a focus group to discuss how the program could be changed to meet the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Caregiver Burnout
- What is being tested?
- Savvy Caregiver Program via Remote Learning and Focus group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 14 Feb 2022
- Phase
- Observational
- 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
Study population: Lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD)
Who may be able to join
- Self-identification as an LGBT adult (18 yrs and over)
- Providing informal care to a community dwelling adult family member or friend for at least 3 months OR
- Was formerly providing informal care to a community dwelling adult family member or friend for at least 6 months no more than 5 years ago
- Willing to participate in a one hour survey
- Agree to participate in up to 12 hours of clinical trial activities, including up to 6 hours of videos
Who cannot join
- Any significant diagnosed systemic illness or unstable diagnosed medical condition that could affect cognition (i.e. MCI), cause difficulty complying with the protocol or consenting for study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Goizueta Alzheimer's Disease Research Center (ADRC)
Atlanta, Georgia, 30322
About this study
The goal of this study is to adapt existing Savvy Caregiving Program (SCP) for lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD). After watching the SCP Remote Learning videos, participants will attend a focus group to discuss how the program could be changed to meet the specific needs of LGBT caregivers of PLWD.
Read the detailed description
Over 15 million family caregivers provide more than $200 billion in unpaid care to a person living with dementia (PLWD). This dynamic has been shown to influence the PLWD, as well as the physiological and psychological health of the caregiver. Depression and stress have been linked to caregiving, and both are independent risk factors for dementia. In addition to subjective indices of stress and depression, stress biomarkers have been shown to be higher in dementia caregivers vs. non-caregivers.
The complex caregiving experience depends on many factors, including the disease state of the PLWD, the nature of the relationship (spouse vs. child vs. friend), as well as the race, ethnicity, gender identity, and sexual orientation of the individuals involved. Informal caregiving for PLWD by lesbian, gay, bisexual, and transgender (LGBT) individuals continues to receive limited attention, and current research rarely examines how caregiving for PLWD affects the LGBT community. Estimates of the number of LGBT adult caregivers range from 27% to more than 45%.
Although the National Institutes of Health and the Institute of Medicine have recently emphasized the disparity in LGBT aging issues, little is known about stress experienced by LGBT caregivers compared with non-LGBT caregivers. Research with LGBT caregivers of PLWD has shown that they experience higher rates of physical, emotional, and financial strain, and are more likely to help with medical/nursing tasks. Higher levels of LGBT caregiver stress may be due to the fact that LGBT caregivers are less likely to seek out supportive services or disclose their LGBT identities. Higher rates of caregiving stress for LGBT caregivers may stem from years of stigma and failure of current interventions and resources to assess the unique stressors of LGBT persons adequately. Fear of discrimination, denial of services, and receiving poor-quality services may also contribute to reluctance to seek assistance. Moreover, LGBT persons are more likely to suffer from behavioral, psychological and physiological health issues than non-LGBT persons, all of which are independent predictors of Alzheimer's disease and related dementias (ADRD).
The Savvy Caregiver Program (SCP) was developed by Kenneth Hepburn PhD to train informal caregivers of community dwelling PLWD. The SCP consists of educational instruction and in-class exercises that engage participants on a functional level. Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a PLWD. The existing SCP is comprised of weekly, two-hour interactive classes, over six consecutive weeks. Dr. Hepburn and his team also created four, one hour and 45 minute long, videos to be used as a method of remote learning that cover the same material as the in-person program. These videos will be used in this study.
The primary goal of this study is to adapt the SCP to address the context-specific challenges faced by LGBT informal caregivers of PLWD, in preparation for a larger efficacy trial. The researchers will conduct focus groups to engage LGBT caregivers and a LGBT Community Advisory Board in the process of adapting the existing SCP to their needs.
- Conditions
- Dementia, Caregiver Burnout
- Being tested
- Savvy Caregiver Program via Remote Learning, Focus group
- Keywords
- Person Living with Dementia (PLWD), Lesbian, Gay, Bisexual, Transgender (LGBT), Informal caregiver, Savvy Caregiving Program, Alzheimer's Disease (AD), Alzheimer's Disease and Related Dementias (ADRD)
- Medical subject headings
- Dementia, Caregiver Burden, Homosexuality, Female, Homosexuality, Bisexuality, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savvy Caregiver Program via Remote LearningBehavioural
Also called Savvy Caregiver Program provided via Pre-Recorded Video
The SCP program is comprised of four pre-recorded Savvy Caregiver videos (each 1 hour and 45 minutes in length). Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a person living with dementia (PLWD). Course learning objectives include: 1) introduction to dementing disorder; 2) caregiver self-care; 3) the anchors of enjoyable involvement; 4) levels of thinking and performance; 5) strengthening the family as a resource for caregiving; and 6) review and integration of the previous sections.
Focus groupBehavioural
After watching the Savvy Caregiver videos participants will take part in a focus group to discuss their experience with the SCP and how the course material applies to them as a LGBT caregiver. The semi-structured discussion will include, but not be limited to the following questions: 1) Can you tell me about your role as a caregiver? (Probes: living situation, experiences, challenges). 2) What went well with the SCP, and what could be improved? 3) How relevant to your situation as an LGBT caregiver were the course materials? 4) How well did the questionnaire reflect your experiences with discrimination due to sexual orientation and/or gender identity? (Probe about when working with your care recipient's health care providers, in-home aides/visiting nurses, adult day care staff, respite, etc? 5) What are some of the additional caregiver challenges that should be considered in these questionnaires? (Probes: mental health, physical health, and social life strain, Quality of life, stress).
| Study group | Role | What they receive |
|---|---|---|
| LGBT Caregivers Participating in a Focus Group | LGBT caregivers attending a focus group after watching the videos of the remote learning Savvy Caregiver Program. The focus group will guide modification of the Savvy Caregiver Program to meet the needs of LGBT caregivers of PLWD. Receives: Behavioral: Savvy Caregiver Program via Remote Learning; Behavioral: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of SCP for LGBT Caregivers of PLWD
A version of the SCP will be developed to meet the needs of LGBT Caregivers of PLWD through focus groups discussing the SCP after participants watch all of the videos. Semi-structured discussions in the focus group will include, but not be limited to the following questions: 1) Can you tell me about your role as a caregiver? 2) What did you like about the SCP, and what could be improved? 3) How relevant to your situation as an LGBT caregiver were the course materials? 4) How well did the questionnaire reflect your experiences with discrimination due to sexual orientation and/or gender identity? 5) What are some of the additional caregiver challenges that should be considered in these questionnaires?
Measured: Day of Focus Group (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 May 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Whitney Wharton, Emory University
- Investigators
- Whitney Wharton, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394260
- Sponsor's protocol ID
- STUDY00002246
- Other IDs
- IRB00113264, 5P30AG064200-02
- Acronym
- EIC
- Status last verified
- Mar 2023
- First submitted
- 15 May 2020
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlies the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equality in Caregiving: Facilitating Caregiver Mastery Among LGBT Caregivers of PLWD
- ClinicalTrials.gov ID
- NCT04394260
- Acronym / sponsor ID
- EIC / STUDY00002246
- Conditions
- Dementia, Caregiver Burnout
- Keywords
- Person Living with Dementia (PLWD), Lesbian, Gay, Bisexual, Transgender (LGBT), Informal caregiver, Savvy Caregiving Program, Alzheimer's Disease (AD), Alzheimer's Disease and Related Dementias (ADRD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 19 May 2020 (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 study is to adapt existing Savvy Caregiving Program (SCP) for lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD). After watching the SCP Remote Learning videos, participants will attend a focus group to discuss how the program could be changed to meet the specific needs of LGBT caregivers of PLWD.
Detailed description
Over 15 million family caregivers provide more than $200 billion in unpaid care to a person living with dementia (PLWD). This dynamic has been shown to influence the PLWD, as well as the physiological and psychological health of the caregiver. Depression and stress have been linked to caregiving, and both are independent risk factors for dementia. In addition to subjective indices of stress and depression, stress biomarkers have been shown to be higher in dementia caregivers vs. non-caregivers.
The complex caregiving experience depends on many factors, including the disease state of the PLWD, the nature of the relationship (spouse vs. child vs. friend), as well as the race, ethnicity, gender identity, and sexual orientation of the individuals involved. Informal caregiving for PLWD by lesbian, gay, bisexual, and transgender (LGBT) individuals continues to receive limited attention, and current research rarely examines how caregiving for PLWD affects the LGBT community. Estimates of the number of LGBT adult caregivers range from 27% to more than 45%.
Although the National Institutes of Health and the Institute of Medicine have recently emphasized the disparity in LGBT aging issues, little is known about stress experienced by LGBT caregivers compared with non-LGBT caregivers. Research with LGBT caregivers of PLWD has shown that they experience higher rates of physical, emotional, and financial strain, and are more likely to help with medical/nursing tasks. Higher levels of LGBT caregiver stress may be due to the fact that LGBT caregivers are less likely to seek out supportive services or disclose their LGBT identities. Higher rates of caregiving stress for LGBT caregivers may stem from years of stigma and failure of current interventions and resources to assess the unique stressors of LGBT persons adequately. Fear of discrimination, denial of services, and receiving poor-quality services may also contribute to reluctance to seek assistance. Moreover, LGBT persons are more likely to suffer from behavioral, psychological and physiological health issues than non-LGBT persons, all of which are independent predictors of Alzheimer's disease and related dementias (ADRD).
The Savvy Caregiver Program (SCP) was developed by Kenneth Hepburn PhD to train informal caregivers of community dwelling PLWD. The SCP consists of educational instruction and in-class exercises that engage participants on a functional level. Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a PLWD. The existing SCP is comprised of weekly, two-hour interactive classes, over six consecutive weeks. Dr. Hepburn and his team also created four, one hour and 45 minute long, videos to be used as a method of remote learning that cover the same material as the in-person program. These videos will be used in this study.
The primary goal of this study is to adapt the SCP to address the context-specific challenges faced by LGBT informal caregivers of PLWD, in preparation for a larger efficacy trial. The researchers will conduct focus groups to engage LGBT caregivers and a LGBT Community Advisory Board in the process of adapting the existing SCP to their needs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LGBT Caregivers Participating in a Focus Group | – | Behavioral: Savvy Caregiver Program via Remote Learning, Behavioral: Focus groupLGBT caregivers attending a focus group after watching the videos of the remote learning Savvy Caregiver Program. The focus group will guide modification of the Savvy Caregiver Program to meet the needs of LGBT caregivers of PLWD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lesbian, gay, bisexual, transgender (LGBT) caregivers of person living with dementia (PLWD)
Key inclusion criteria (5 listed)
- Self-identification as an LGBT adult (18 yrs and over)
- Providing informal care to a community dwelling adult family member or friend for at least 3 months OR
- Was formerly providing informal care to a community dwelling adult family member or friend for at least 6 months no more than 5 years ago
- Willing to participate in a one hour survey
- Agree to participate in up to 12 hours of clinical trial activities, including up to 6 hours of videos
Key exclusion criteria (1 listed)
- Any significant diagnosed systemic illness or unstable diagnosed medical condition that could affect cognition (i.e. MCI), cause difficulty complying with the protocol or consenting for study procedures
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 |
|---|---|---|
| Savvy Caregiver Program via Remote LearningAlso: Savvy Caregiver Program provided via Pre-Recorded VideoThe SCP program is comprised of four pre-recorded Savvy Caregiver videos (each 1 hour and 45 minutes in length). Course material was designed to provide informal caregivers with the knowledge, skills, and attitude needed to carry out their role as a caregiver for a person living with dementia (PLWD). Course learning objectives include: 1) introduction to dementing disorder; 2) caregiver self-care; 3) the anchors of enjoyable involvement; 4) levels of thinking and performance; 5) strengthening the family as a resource for caregiving; and 6) review and integration of the previous sections. | Behavioural | LGBT Caregivers Participating in a Focus Group |
| Focus groupAfter watching the Savvy Caregiver videos participants will take part in a focus group to discuss their experience with the SCP and how the course material applies to them as a LGBT caregiver. The semi-structured discussion will include, but not be limited to the following questions: 1) Can you tell me about your role as a caregiver? (Probes: living situation, experiences, challenges). 2) What went well with the SCP, and what could be improved? 3) How relevant to your situation as an LGBT caregiver were the course materials? 4) How well did the questionnaire reflect your experiences with discrimination due to sexual orientation and/or gender identity? (Probe about when working with your care recipient's health care providers, in-home aides/visiting nurses, adult day care staff, respite, etc? 5) What are some of the additional caregiver challenges that should be considered in these questionnaires? (Probes: mental health, physical health, and social life strain, Quality of life, stress). | Behavioural | LGBT Caregivers Participating in a Focus Group |
Primary outcome
Development of SCP for LGBT Caregivers of PLWD
Time frame: Day of Focus Group (Day 1)
A version of the SCP will be developed to meet the needs of LGBT Caregivers of PLWD through focus groups discussing the SCP after participants watch all of the videos. Semi-structured discussions in the focus group will include, but not be limited to the following questions: 1) Can you tell me about your role as a caregiver? 2) What did you like about the SCP, and what could be improved? 3) How relevant to your situation as an LGBT caregiver were the course materials? 4) How well did the questionnaire reflect your experiences with discrimination due to sexual orientation and/or gender identity? 5) What are some of the additional caregiver challenges that should be considered in these questionnaires?
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 Mar 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlies the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
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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.
Whitney Wharton, PhD 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?
An observational study of Dementia and Caregiver Burnout, 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 1 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 Mar 2023. 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?
Development of SCP for LGBT Caregivers of PLWD (time frame: Day of Focus Group (Day 1)). 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 Mar 2023.