Clinical trial NCT03289624: SHARE for Persons With Chronic Conditions and Their Family Caregivers
Official title: Support, Health, Activities, Resources, and Education for Persons With Chronic Conditions and Their Family Caregivers: SHARE-Chronic Conditions (SHARE-CC)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Health Conditions
Family Caregivers
Keywords: Care Planning
Care Values and Preferences
Lead sponsor: Benjamin Rose Institute on Aging
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Persons with chronic conditions and their family caregivers will be randomly assigned to a treatment or control group
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from Baseline Service Availability Measure (SAM) at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Emotional-Intimacy Disruptive Behavior Scale at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months
timeFrame: Measured at baseline and 4 months later
Secondary outcomes:
measure: Change from Baseline Dyadic Relationship Scale at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Health Care Utilization at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Disagreements Scale at 4 months
timeFrame: Measured at baseline and 4 months later
Other outcomes:
measure: Change from Baseline Partners in Health Scale at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Care Values Scale at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Leisure and Healthy Behaviors Scale at 4 months
timeFrame: Measured at baseline and 4 months later
measure: Change from Baseline Preferences for Care Tasks Scale at 4 months
timeFrame: Measured at baseline and 4 months later
Locations:
city: San Diego
country: United States
facility: Southern Caregiver Resource Center
state: California
city: San Francisco
country: United States
facility: Family Caregiver Alliance
state: California
city: Ridgewood
country: United States
facility: Geriatric Care Consultant
state: New Jersey
city: Cleveland
country: United States
facility: Benjamin Rose Institute on Aging
state: Ohio
Study officials:
affiliation: Benjamin Rose Institute on Aging
name: Carol Whitlatch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Benjamin Rose Institute on Aging
name: Silvia Orsulic-Jeras
role: STUDY_DIRECTOR
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