SHARE for Persons With Chronic Conditions and Their Family Caregivers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Support, Health, Activities, Resources, and Education for Persons With Chronic Conditions and Their Family Caregivers: SHARE-Chronic Conditions (SHARE-CC)

Conditions
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Chronic Health Conditions, Family Caregivers

Intervention / Treatment
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* Behavioral: SHARE-CC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Persons with chronic conditions and their family caregivers will be randomly assigned to a treatment or control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHARE for Chronic Conditions<br>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. | Behavioral: SHARE-CC<br>* Each of the 6 SHARE-CC sessions are structured similarly, starting with the dyad reviewing goals of the session, the CG & PWCC meeting jointly or separately with the SHARE-CC Counselor around session-specific material, & ending with a review of material, addressing questions, & previewing the next session. Sessions titles are: Communication & Health Education; Care Values; Care Preferences; Family, Friends, & Community Resources; Taking care of yourself-taking care of each other; & Take Action Now. The SHARE plan will be developed throughout the sessions and reflects the consensus achieved because of participating in SHARE-CC. It is intended to ensure that the PWCC's values & preferences are supported when decisions have to be in the future.<br>|
| No Intervention: Health Coaching<br>Six 30-minute weekly telephone calls to provide information and education related to the PWCC's conditions and information about services and care options will be conducted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Service Availability Measure (SAM) at 4 months | 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 | Measured at baseline and 4 months later | 
| Change from Baseline Emotional-Intimacy Disruptive Behavior Scale at 4 months | 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?). | Measured at baseline and 4 months later | 
| Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months | 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 | Measured at baseline and 4 months later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Dyadic Relationship Scale at 4 months | The Dyadic Relationship Scale includes the Positive Dyadic Interactions and Negative Dyadic Strain subscales. | Measured at baseline and 4 months later | 
| Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months | 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 | Measured at baseline and 4 months later | 
| Change from Baseline Health Care Utilization at 4 months | Four single items that measure self-reported physician visits, hospital emergency room visits, and overnight hospital stays in the past four months. | Measured at baseline and 4 months later | 
| Change from Baseline Disagreements Scale at 4 months | 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. | Measured at baseline and 4 months later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Care Planning, Care Values and Preferences