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Clinical Trials/NCT03289624
NCT03289624
Withdrawn
Not Applicable

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

Benjamin Rose Institute on Aging4 sites in 1 countryAugust 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Health Conditions
Sponsor
Benjamin Rose Institute on Aging
Locations
4
Primary Endpoint
Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2017
End Date
August 31, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Change from Baseline Dyadic Relationship Scale at 4 months(Measured at baseline and 4 months later)
  • Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months(Measured at baseline and 4 months later)
  • Change from Baseline Disagreements Scale at 4 months(Measured at baseline and 4 months later)
  • Change from Baseline Health Care Utilization at 4 months(Measured at baseline and 4 months later)

Study Sites (4)

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