SHARE for Persons With Chronic Conditions and Their Family Caregivers
- Conditions
- Family CaregiversChronic Health Conditions
- Interventions
- Behavioral: SHARE-CC
- Registration Number
- NCT03289624
- Lead Sponsor
- Benjamin Rose Institute on Aging
- Brief Summary
SHARE-CC is an intervention for families facing the challenges of chronic conditions. SHARE-CC (Support, Help, Activities, Resources, and Education) addresses the need for both members of a care dyad to be actively involved in current and future care planning. This intervention aims to increase knowledge of services, improve communication skills and well-being, and facilitate the understanding of care values and preferences in order to create a mutually agreed upon care plan. This intervention will be tested in a randomized control trial.
- Detailed Description
This project offers a unique and timely opportunity to evaluate the feasibility, acceptability, and efficacy of the SHARE-Chronic Conditions psycho-social intervention. The project will adapt the SHARE intervention, for use with dyads facing the challenges of chronic conditions. The six-session SHARE-CC program will be implemented and evaluated using a randomized controlled trial with 240 participants in northern Ohio, the San Diego and San Francisco Bay areas in California, and New Jersey.
The SHARE-CC intervention addresses the need for a structured approach that targets both members of a care dyad and empowers them to be actively involved in current and future care planning. It has great potential to not only improve psychosocial outcomes for families, but to also impact healthcare decision-making and utilization.
Persons with chronic conditions and their caregivers will be interviewed prior to (Time 1) and after participating (approximately 4 months post-Time 1) in the SHARE-CC intervention or PWCC control group.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
PWCC:
- Living in geographic area of organizations delivering service
- Living at home rather than in an institutional setting
- Have a family CG as defined below
- Confirmed diagnosis of at least one chronic illness (e.g., heart disease, diabetes, COPD, arthritis, kidney disease, stroke, HIV-AIDS, etc.)
- Require assistance with two or more activities of daily living (e.g., shopping, managing medications, dressing) or receives help with complex medical care tasks (e.g., wound care, preparing special meals); and
- Short Blessed error score between 0 and 6 demonstrating normal cognitive function.
For CGs to be eligible
• must be the PWCC's spouse/partner, adult child, in-law, grandchild, step-child, or other close family member who has or will have primary responsibility for providing assistance to the PWCC
- Out of geographic areas
- a primary diagnosis of a neurocognitive disorder (e.g. Alzheimer's Disease or related dementia)
- a mental health condition (e.g., schizophrenia, bipolar disorder, major depression)
- a traumatic brain injury,
- intellectual or developmental disability
- individuals experiencing extreme difficulty adjusting and coping to the diagnosis
- individuals in the terminal phase of a chronic condition (i.e., eligible for Hospice).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHARE for Chronic Conditions SHARE-CC Six weekly "SHARE for Chronic Conditions (SHARE-CC)" sessions will be conducted in the dyad's home or another location preferred by the participants. A care plan (the SHARE plan) is created that reflects the mutual decisions made by the dyad as a result of their participation in the SHARE-CC program. The SHARE plan is intended to help the caregiver (CG) ensure the PWCC's values and preferences are supported when decisions have to be made in an emergency or in the end stages of the disease. SHARE plans will be documented in a notebook that also contains information on key topics and provides links to local and online resources and services.
- Primary Outcome Measures
Name Time Method Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months Measured at baseline and 4 months later To measures affect, we will use the Positive Affect (6 items) and Negative Affect (9 items) scales of the Dementia Quality of Life Instrument (DQoL; Brod et al., 1999), modified to include only the positive and negative affect subscales in order to reduce response burden
Change from Baseline Service Availability Measure (SAM) at 4 months Measured at baseline and 4 months later Asks caregiver if they or their care partner have used any of the 14 services listed (i.e., counseling, support group, respite). If a caregiver has not used a service then their knowledge of the availability of that service is measured
Change from Baseline Emotional-Intimacy Disruptive Behavior Scale at 4 months Measured at baseline and 4 months later Assesses the extent to which a person engaged in eight behaviors during the past month related to withholding or distorting information about their symptoms and feelings to protect their partner from worrying (i.e., how often have you acted more cheerful than you feel?).
- Secondary Outcome Measures
Name Time Method Change from Baseline Dyadic Relationship Scale at 4 months Measured at baseline and 4 months later The Dyadic Relationship Scale includes the Positive Dyadic Interactions and Negative Dyadic Strain subscales.
Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months Measured at baseline and 4 months later A 20-item measure that asks the respondent to rate how often they experienced symptoms of depression in the past week (i.e., restless sleep). Scores range from 0-60, with scores of 16 or more indicating risk for clinical depression
Change from Baseline Disagreements Scale at 4 months Measured at baseline and 4 months later The Disagreements Scale asks respondents five questions about whether they agree or disagree with their care partner about planning, finances, deciding where to go, planning for care, etc.
Change from Baseline Health Care Utilization at 4 months Measured at baseline and 4 months later Four single items that measure self-reported physician visits, hospital emergency room visits, and overnight hospital stays in the past four months.
Trial Locations
- Locations (4)
Benjamin Rose Institute on Aging
🇺🇸Cleveland, Ohio, United States
Southern Caregiver Resource Center
🇺🇸San Diego, California, United States
Family Caregiver Alliance
🇺🇸San Francisco, California, United States
Geriatric Care Consultant
🇺🇸Ridgewood, New Jersey, United States