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Recruitment Status : Withdrawn (Lost Funding)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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Health Conditions Family Caregivers||Behavioral: SHARE-CC||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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 Description:||No other parties will be masked in the trial|
|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|
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.
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.
- 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?).
- 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 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.
- 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
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
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
|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|
|Principal Investigator:||Carol Whitlatch, PhD||Benjamin Rose Institute on Aging|
|Study Director:||Silvia Orsulic-Jeras||Benjamin Rose Institute on Aging|