- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03289624
SHARE for Persons With Chronic Conditions and Their Family Caregivers (SHARE-CC)
Support, Health, Activities, Resources, and Education for Persons With Chronic Conditions and Their Family Caregivers: SHARE-Chronic Conditions (SHARE-CC)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92123
- Southern Caregiver Resource Center
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San Francisco, California, United States, 94104
- Family Caregiver Alliance
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New Jersey
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Ridgewood, New Jersey, United States, 07459
- Geriatric Care Consultant
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Ohio
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Cleveland, Ohio, United States, 44120
- Benjamin Rose Institute on Aging
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Measured at baseline and 4 months later
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Change from Baseline Emotional-Intimacy Disruptive Behavior Scale at 4 months
Time Frame: Measured at baseline and 4 months later
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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?).
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Measured at baseline and 4 months later
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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
|
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
Time Frame: Measured at baseline and 4 months later
|
The Dyadic Relationship Scale includes the Positive Dyadic Interactions and Negative Dyadic Strain subscales.
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Measured at baseline and 4 months later
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Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months
Time Frame: Measured at baseline and 4 months later
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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
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Measured at baseline and 4 months later
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Change from Baseline Health Care Utilization at 4 months
Time Frame: Measured at baseline and 4 months later
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Four single items that measure self-reported physician visits, hospital emergency room visits, and overnight hospital stays in the past four months.
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Measured at baseline and 4 months later
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Change from Baseline Disagreements Scale at 4 months
Time Frame: Measured at baseline and 4 months later
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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.
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Measured at baseline and 4 months later
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Measured at baseline and 4 months later
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Change from Baseline Care Values Scale at 4 months
Time Frame: Measured at baseline and 4 months later
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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).
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Measured at baseline and 4 months later
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Change from Baseline Leisure and Healthy Behaviors Scale at 4 months
Time Frame: Measured at baseline and 4 months later
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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).
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Measured at baseline and 4 months later
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Change from Baseline Preferences for Care Tasks Scale at 4 months
Time Frame: Measured at baseline and 4 months later
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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.
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Measured at baseline and 4 months later
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carol Whitlatch, PhD, Benjamin Rose Institute on Aging
- Study Director: Silvia Orsulic-Jeras, Benjamin Rose Institute on Aging
Publications and helpful links
General Publications
- Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.
- Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.
- Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
- Ritter PL, Stewart AL, Kaymaz H, Sobel DS, Block DA, Lorig KR. Self-reports of health care utilization compared to provider records. J Clin Epidemiol. 2001 Feb;54(2):136-41. doi: 10.1016/s0895-4356(00)00261-4.
- 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.
- Druley JA, Stephens MA, Coyne JC. Emotional and physical intimacy in coping with lupus: women's dilemmas of disclosure and approach. Health Psychol. 1997 Nov;16(6):506-14. doi: 10.1037//0278-6133.16.6.506.
- 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.
- Whitlatch CJ, Feinberg LF, Tucke SS. Measuring the values and preferences for everyday care of persons with cognitive impairment and their family caregivers. Gerontologist. 2005 Jun;45(3):370-80. doi: 10.1093/geront/45.3.370.
- Feinberg LF, Whitlatch CJ. Decision-making for persons with cognitive impairment and their family caregivers. Am J Alzheimers Dis Other Demen. 2002 Jul-Aug;17(4):237-44. doi: 10.1177/153331750201700406.
- Zarit SH, Stephens MA, Townsend A, Greene R. Stress reduction for family caregivers: effects of adult day care use. J Gerontol B Psychol Sci Soc Sci. 1998 Sep;53(5):S267-77. doi: 10.1093/geronb/53b.5.s267.
- Mullan JT. The bereaved caregiver: a prospective study of changes in well-being. Gerontologist. 1992 Oct;32(5):673-83. doi: 10.1093/geront/32.5.673.
- 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
- Brod M, Stewart AL, Sands L, Walton P. Conceptualization and measurement of quality of life in dementia: the dementia quality of life instrument (DQoL). Gerontologist. 1999 Feb;39(1):25-35. doi: 10.1093/geront/39.1.25.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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