Back to resultsSHARE for Persons With Chronic Conditions and Their Family Caregivers (SHARE-CC)
Primary Purpose
Chronic Health Conditions, Family Caregivers
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHARE-CC
Sponsored by
About this trial
This is an interventional other trial for Chronic Health Conditions focused on measuring Care Planning, Care Values and Preferences
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).
Sites / Locations
- Southern Caregiver Resource Center
- Family Caregiver Alliance
- Geriatric Care Consultant
- Benjamin Rose Institute on Aging
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SHARE for Chronic Conditions
Health Coaching
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from Baseline Service Availability Measure (SAM) at 4 months
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
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
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
Change from Baseline Dyadic Relationship Scale at 4 months
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
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
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
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.
Full Information
NCT ID
NCT03289624
First Posted
August 18, 2017
Last Updated
August 24, 2020
Sponsor
Benjamin Rose Institute on Aging
1. Study Identification
Unique Protocol Identification Number
NCT03289624
Brief Title
SHARE for Persons With Chronic Conditions and Their Family Caregivers
Acronym
SHARE-CC
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lost Funding
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benjamin Rose Institute on Aging
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Health Conditions, Family Caregivers
Keywords
Care Planning, Care Values and Preferences
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Persons with chronic conditions and their family caregivers will be randomly assigned to a treatment or control group
Masking
Participant
Masking Description
No other parties will be masked in the trial
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHARE for Chronic Conditions
Arm Type
Experimental
Arm Description
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.
Arm Title
Health Coaching
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SHARE-CC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Service Availability Measure (SAM) at 4 months
Description
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
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Emotional-Intimacy Disruptive Behavior Scale at 4 months
Description
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?).
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Positive Affect and Negative Affect scales (DQoL) at 4 months
Description
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
Time Frame
Measured at baseline and 4 months later
Secondary Outcome Measure Information:
Title
Change from Baseline Dyadic Relationship Scale at 4 months
Description
The Dyadic Relationship Scale includes the Positive Dyadic Interactions and Negative Dyadic Strain subscales.
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Center for Epidemiological Studies Depression Scale (CES-D) at 4 months
Description
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
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Health Care Utilization at 4 months
Description
Four single items that measure self-reported physician visits, hospital emergency room visits, and overnight hospital stays in the past four months.
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Disagreements Scale at 4 months
Description
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.
Time Frame
Measured at baseline and 4 months later
Other Pre-specified Outcome Measures:
Title
Change from Baseline Partners in Health Scale at 4 months
Description
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.
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Care Values Scale at 4 months
Description
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).
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Leisure and Healthy Behaviors Scale at 4 months
Description
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).
Time Frame
Measured at baseline and 4 months later
Title
Change from Baseline Preferences for Care Tasks Scale at 4 months
Description
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.
Time Frame
Measured at baseline and 4 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Whitlatch, PhD
Organizational Affiliation
Benjamin Rose Institute on Aging
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Orsulic-Jeras
Organizational Affiliation
Benjamin Rose Institute on Aging
Official's Role
Study Director
Facility Information:
Facility Name
Southern Caregiver Resource Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Family Caregiver Alliance
City
San Francisco
State/Province
California
ZIP/Postal Code
94104
Country
United States
Facility Name
Geriatric Care Consultant
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07459
Country
United States
Facility Name
Benjamin Rose Institute on Aging
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
9386995
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18192628
Citation
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.
Results Reference
background
PubMed Identifier
15933277
Citation
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.
Results Reference
background
PubMed Identifier
12184513
Citation
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.
Results Reference
background
PubMed Identifier
9750575
Citation
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.
Results Reference
background
PubMed Identifier
649936
Citation
Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
Results Reference
background
PubMed Identifier
1427280
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
5349366
Citation
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.
Results Reference
background
PubMed Identifier
10028768
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Radloff, L.S., & Teri, L. (1986). Use of the Center for Epidemiological Studies-Depression Scale with older adults. Clinical Gerontologist, 5, 119-136.
Results Reference
background
PubMed Identifier
11166528
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
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SHARE for Persons With Chronic Conditions and Their Family Caregivers
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