Equality in Caregiving

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2022

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 and bisexual (LGB) individuals continues to receive limited attention, and current research rarely examines how caregiving for PLWD affects the LGB community.

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

Interventions

  • 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.
  • Behavioral: Modified LGB Savvy Group program
    • The LGB 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 LGB 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 LGB caregivers.
  • Behavioral: Focus group
    • Participants will be asked to return to take part in one, 90-minute focus group to discuss their experience with the SCP and how the course material applies to them as a LGB 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 LGB 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).

Arms, Groups and Cohorts

  • 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.
  • Experimental: Modified LGB Savvy Group program
    • LGB-friendly SCP is designed to assess the stressors and unique needs of LGB 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 LGB caregivers.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Change in systolic blood pressure
    • Time Frame: Baseline, 6-week follow up
    • Blood pressure will be measured using sphygmomanometer
  • Change in diastolic blood pressure
    • Time Frame: Baseline, 6-week follow up
    • Blood pressure will be measured using sphygmomanometer
  • Change in cortisol level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the stress marker
  • Change in C-reactive protein (CRP) level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in interleukin-7 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in iinterleukin-8 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in interleukin-9 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in interleukin-10 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in interferon induced protein 10 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in macrophage derived chemokine level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in monocyte chemoattractant protein 1 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in itransforming growth factor alpha level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in tumor necrosis factor alpha level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the inflammatory marker
  • Change in ICAM-1 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the endothelial marker
  • Change in VCAM-1 level
    • Time Frame: Baseline, 6-week follow up
    • Blood test will be used to measure the endothelial marker

Participating in This Clinical Trial

Inclusion Criteria

1. Self-identification as a LBG 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)

Gender Eligibility: All

Self-identification as a LBG adult

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Emory University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Whitney Wharton, Associate Professor – Emory University
  • Overall Official(s)
    • Whitney Wharton, PhD, Principal Investigator, Emory University
  • Overall Contact(s)
    • Whitney Wharton, PhD, 404-712-7359, w.wharton@emory.edu

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