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SHARE for Persons With Chronic Conditions and Their Family Caregivers (SHARE-CC)

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ClinicalTrials.gov Identifier: NCT03289624
Recruitment Status : Withdrawn (Lost Funding)
First Posted : September 21, 2017
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Health Conditions Family Caregivers Behavioral: SHARE-CC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Persons with chronic conditions and their family caregivers will be randomly assigned to a treatment or control group
Masking: Single (Participant)
Masking Description: No other parties will be masked in the trial
Primary Purpose: Other
Official Title: Support, Health, Activities, Resources, and Education for Persons With Chronic Conditions and Their Family Caregivers: SHARE-Chronic Conditions (SHARE-CC)
Actual Study Start Date : August 15, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: SHARE for Chronic Conditions
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

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.


No Intervention: Health Coaching
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.



Primary Outcome Measures :
  1. 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

  2. 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?).

  3. 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


Secondary Outcome Measures :
  1. Change from Baseline Dyadic Relationship Scale at 4 months [ Time Frame: Measured at baseline and 4 months later ]
    The Dyadic Relationship Scale includes the Positive Dyadic Interactions and Negative Dyadic Strain subscales.

  2. Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months [ Time Frame: 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

  3. Change from Baseline Health Care Utilization at 4 months [ Time Frame: 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.

  4. Change from Baseline Disagreements Scale at 4 months [ Time Frame: 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.


Other Outcome Measures:
  1. Change from Baseline Partners in Health Scale at 4 months [ Time Frame: Measured at baseline and 4 months later ]
    An 11-item scale that measures a person's perception of their level of chronic condition(s) self-management using a 9-point rating scale, with responses ranging from 0=very good to 8=very poor.

  2. Change from Baseline Care Values Scale at 4 months [ Time Frame: Measured at baseline and 4 months later ]
    A 25-item scale that measures the patient's and caregiver's perceptions of the patient's thoughts and feelings about what is most important to them should they need care in the future related to six specific care values (response options include: very important, somewhat important, not so important).

  3. Change from Baseline Leisure and Healthy Behaviors Scale at 4 months [ Time Frame: Measured at baseline and 4 months later ]
    The Leisure Scale measures how often the respondent engaged in 14 different activities (i.e., go shopping, play games). Response options range from 1 (not at all) to 3 (often). The 7-item Healthy Behaviors Scale measures how often the respondent engaged in a variety of health related behaviors (i.e., you got an adequate amount of sleep, you ate too much or too little).

  4. Change from Baseline Preferences for Care Tasks Scale at 4 months [ Time Frame: Measured at baseline and 4 months later ]
    Patients and caregiver's perceptions of the patient's preferences for who they would prefer to help them with 19 care tasks (i.e., shopping, bathing) if they needed assistance in the future. The responses options include: caregiver, other family or friends, and paid providers.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289624


Locations
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United States, California
Southern Caregiver Resource Center
San Diego, California, United States, 92123
Family Caregiver Alliance
San Francisco, California, United States, 94104
United States, New Jersey
Geriatric Care Consultant
Ridgewood, New Jersey, United States, 07459
United States, Ohio
Benjamin Rose Institute on Aging
Cleveland, Ohio, United States, 44120
Sponsors and Collaborators
Benjamin Rose Institute on Aging
Investigators
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Principal Investigator: Carol Whitlatch, PhD Benjamin Rose Institute on Aging
Study Director: Silvia Orsulic-Jeras Benjamin Rose Institute on Aging
Publications:
Whitlatch, C.J., Clark, P.A., & Schur, D. (2000). COPE: Caregiver Options Program and Evaluation. Final report to nine Cleveland foundations. Benjamin Rose Institute, Cleveland.
Battersby, M.W., Ask, A., Reece, M.M., Markwick, M.J., & Collins, J.P. (2003). The Partners in Health scale: The development and psychometric properties of a generic assessment scale for chronic condition self- management. Australian Journal of Primary Health, 9(2 & 3), 41-52.
Bass, D. M., Tausig, M. B., & Noelker, L. S. (1988). Elder impairment,social support and caregiver strain: A framework for understanding support's effects. Journal of Applied Social Sciences, 13, 80-117.
Aneshensel, C.S., Pearlin, L.I., Mullan, J.T., Zarit, S.H., & Whitlatch,C.J. (1995). Profiles in caregiving: The unexpected career. San Diego, CA: Academic Press
Radloff, L.S. (1977). The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 11, 385-401.
Radloff, L.S., & Teri, L. (1986). Use of the Center for Epidemiological Studies-Depression Scale with older adults. Clinical Gerontologist, 5, 119-136.
Lorig, K., Stewart, A., Ritter, P.L., Gonzalez, V., Laurent, D., & Lynch,J. (1996). Outcome Measures for Health Education and other Health Care Interventions. Thousand Oak, CA: Sage Publications, 24-25

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Responsible Party: Benjamin Rose Institute on Aging
ClinicalTrials.gov Identifier: NCT03289624    
Other Study ID Numbers: 2016-003
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Rose Institute on Aging:
Care Planning
Care Values and Preferences
Additional relevant MeSH terms:
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Disease
Pathologic Processes