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Equality in Caregiving (EIC)

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ClinicalTrials.gov Identifier: NCT04394260
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Whitney Wharton, Emory University

Brief Summary:
The primary goal of this pilot clinical trial is to establish the readiness of an intervention addressing the unique challenges facing lesbian, gay, bisexual, and transgender (LGBT) informal caregivers of person living with dementia (PLWD), and geared toward achieving caregiver mastery in this high-risk population, for a larger efficacy trial.

Condition or disease Intervention/treatment Phase
Dementia Caregiver Burnout Behavioral: Savvy Caregiver Program Behavioral: Modified LGBT Savvy Group program Behavioral: Focus group Not Applicable

Detailed Description:

Over 15 million family caregivers provide more than $200 billion in unpaid care to a person living with dementia (PLWD). 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.

The primary goal of this pilot clinical trial is to establish the readiness of an intervention addressing the unique challenges facing LGBT informal caregivers of PLWD, and geared toward achieving caregiver mastery in this high-risk population for a larger efficacy trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Equality in Caregiving: Intervention to Facilitate Caregiver Mastery Among LGBT Caregivers of PLWD
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Active Comparator: Savvy Caregiver Program (SCP)
The SCP program is comprised of weekly, two-hour interactive classes, over six consecutive weeks, the same duration as the proposed intervention. 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 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.
Behavioral: Savvy Caregiver Program
The SCP program is comprised of weekly, two-hour interactive classes, over six consecutive weeks, the same duration as the proposed intervention. The SCP consists of educational instruction and in-class exercises that engage participants on a functional level. 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.
Other Name: Savvy Caregiver Program provided via Zoom

Behavioral: Focus group
Participants will be asked to return to take part in a 90-minute focus group to discuss their experience with the SCP and how the course material applies to them as a LGBT caregiver. Focus Group: 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).

Experimental: Modified LGBT Savvy Group program
LGBT-friendly SCP is designed to assess the stressors and unique needs of LGBT caregivers of PLWD, not reflected in the existing SCP. Modifications to the SCP include themes of physical, interpersonal, financial, social, and environmental stressors specific to LGBT caregivers.
Behavioral: Modified LGBT Savvy Group program
The LGBT adapted SCP is the same duration as the existing SCP (i.e., 6 weeks, 2 hours per week, for a total of 12 hours). The program facilitators, clinical study visits and standardized questionnaires are similar for LGBT SCP intervention, however addition or removal of questionnaires is possible.Modifications to the SCP include themes of physical, interpersonal, financial, social, and environmental stressors specific to LGBT caregivers.
Other Name: Modified LGBT Savvy Group program provided via Zoom

Behavioral: Focus group
Participants will be asked to return to take part in a 90-minute focus group to discuss their experience with the SCP and how the course material applies to them as a LGBT caregiver. Focus Group: 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).




Primary Outcome Measures :
  1. Change in Caregiver Depression Center for Epidemiologic Studies Depression Scale (CES-〖D)〗score [ Time Frame: Baseline, 6-week follow up ]
    A 20-item scale that represents a symptom cluster consisting of negative affect, positive affect, interpersonal problems, and somatic activity based on feelings over the past week.Scores range 0 - 60. A score of 0-16 indicates little to no symptomatology, a score of 16 or more indicates depression with higher scores indicating increased severity.


Secondary Outcome Measures :
  1. Change in Caregiver Burden The Zarit Burden Interview score [ Time Frame: Baseline, 6-week follow up ]
    The interview was developed to measure subjective burden among caregivers of adults with dementia. The 22-item self-report inventory examines burden associated with functional/behavioral impairments and the home care situation. The items are worded subjectively, focusing on the affective response of the caregiver. Scores range 0 - 88. Lower scores indicate little to no burden. Higher scores indicate greater burden. A score of 17 or more is considered high burden.

  2. Change in Caregiver Stress Perceived Stress Survey score [ Time Frame: Baseline, 6-week follow up ]
    This questionnaire is comprised of 10 items from the Perceived Stress Scale. Scores range 0 - 40. Higher scores indicating higher perceived stress. A score of 0-13 would be considered low stress. Scores from 14-26 would be considered moderate stress. Scores from 27-40 indicate high perceived stress.

  3. Change in Caregiver Mastery Pearlin Caregiver Stress Scale score [ Time Frame: Baseline, 6-week follow up ]
    Comprised of 6 domains from the full Pearlin Stress Scale. 1. Relational Deprivation: 6-24, higher scores indicate increased relational deprivation. 2. Role Captivity: 3 - 12, higher scores indicate an increased feeling of being trapped in the caregiver role. 3. Loss of Self: 2 - 8, higher scores indicate a greater loss of self. 4. Caregiving competence: 4 - 16, higher scores indicate greater caregiving competence. 5. Management of Situation: 4 - 16, higher scores indicate better management of the caregiving situation. 6. Management of Meaning: 9 - 36, higher scores indicate a better management of the meaning of the caregiving role.

  4. Change in Positive Aspects of Caregiving (PCOS) Scale score [ Time Frame: Baseline, 6-week follow up ]
    Caregivers will be instructed that "In spite of all the difficulties involved in giving care to a family member with memory or health problems, good things can come out of caregiving experiences." The scale has 11 items, and overall scores range 0 - 44. Higher scores indicate a more positive view of the caregiving role while lower scores indicate less positive views of the caregiver role.

  5. Change in Care recipient quality of life DEMQOL: Dementia Quality of Life Measure (Carer v4) score [ Time Frame: Baseline, 6-week follow up ]
    This 32 item questionnaire will be used to assess mood, cognitive status, and overall quality of life of the care recipient. Scores range 31 - 124. Lower scores indicate no subjective concerns about cognition or general health, while higher scores indicate a greater subjective concern about cognition and general health.

  6. Change in Behavioral and Psychological Symptoms of Dementia Revised Memory and Behavior Problem Checklist (RMBPC) score [ Time Frame: Baseline, 6-week follow up ]
    This 24 item instrument measures the frequency of the care recipient's problem behaviors in the following domains: disruptive behavior (wandering, aggression), memory-related behavior (repeating questions and stories), and depression. Scores range 0 - 96 for frequency. Lower scores indicate little to no behavioral problems while higher scores indicate greater behavioral issues. Scores range 0 - 96 for reaction. Lower scores indicate little concern regarding the behavior on the part of the caregiver while higher scores indicate greater concern.

  7. Change in Family Quality of Life in Dementia Scale score [ Time Frame: Baseline, 6-week follow up ]
    Yet unpublished survey is about how the caregiver feels their life together is as a "family". The family can include many different people. Scores range 41 - 205. Lower scores indicate poor quality of life as a family dealing with a loved one with dementia while higher scores indicate a higher quality of life as a family.

  8. Change in Nursing Skills Questionnaire score [ Time Frame: Baseline, 6-week follow up ]
    Adapted from an AARP survey, this questionnaire assesses the likelihood of a caregiver to engage in nursing type skills with their care recipient. Scores range 0 - 34. Lower scores indicate the caregiver is less likely to complete nursing tasks with their care recipient while higher scores indicate the caregiver is more likely to complete nursing tasks.

  9. Change in systolic blood pressure [ Time Frame: Baseline, 6-week follow up ]
    Blood pressure will be measured using sphygmomanometer

  10. Change in diastolic blood pressure [ Time Frame: Baseline, 6-week follow up ]
    Blood pressure will be measured using sphygmomanometer

  11. Change in cortisol level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the stress marker

  12. Change in C-reactive protein (CRP) level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  13. Change in interleukin-7 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  14. Change in interleukin-8 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  15. Change in interleukin-9 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  16. Change in interleukin-10 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  17. Change in interferon induced protein 10 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  18. Change in macrophage derived chemokine level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  19. Change in monocyte chemoattractant protein 1 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  20. Change in itransforming growth factor alpha level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  21. Change in tumor necrosis factor alpha level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the inflammatory marker

  22. Change in ICAM-1 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the endothelial marker

  23. Change in VCAM-1 level [ Time Frame: Baseline, 6-week follow up ]
    Blood test will be used to measure the endothelial marker



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identification as a LGBT adult
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Self-identification as a LGBT adult (18 yrs. and over)
  2. Provides informal care to a community dwelling family member or friend with dementia
  3. Available to attend all SCP classes and one focus group and
  4. Consent to blood draw

Exclusion Criteria:

  1. Residence in a skilled nursing facility
  2. Significant neurological disease, stroke, TBI, or significant head trauma
  3. Any significant systemic illness or unstable medical condition which could affect cognition, cause difficulty complying with the protocol or consenting for study procedures
  4. History of alcohol substance abuse or dependence
  5. Currently participating in a study with an intervention (i.e., social/behavioral, drug, or device)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394260


Contacts
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Contact: Whitney Wharton, PhD 404-712-7359 w.wharton@emory.edu
Contact: Morgan Hecker 404-712-2654 morgan.hecker@emory.edu

Locations
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United States, Georgia
Emory Goizueta Alzheimer's Disease Research Center (ADRC) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Whitney Wharton, PhD    404-712-7359    w.wharton@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Whitney Wharton, PhD Emory University
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Responsible Party: Whitney Wharton, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT04394260    
Other Study ID Numbers: STUDY00002246
IRB00113264 ( Other Identifier: Emory University )
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlies the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Immediately following publication with no end date
Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal will get access. Proposals should be directed to (w.wharton@emory.edu). To gain access, data requestors will need to sign a data access agreement. Data will then be shared directly via csv or excel file.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Whitney Wharton, Emory University:
PLWD
LGBT
Informal caregiver
Savvy Caregiving Program
Additional relevant MeSH terms:
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Burnout, Psychological
Stress, Psychological
Behavioral Symptoms