SHARE for Persons With Chronic Conditions and Their Family Caregivers

NCT03289624 | Withdrawn

• 1 other identifier: 2016-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Health Conditions; Family Caregivers

Keywords

Care Planning; Care Values and Preferences

Outcome Measures

Primary Outcomes (3)

• 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

  Measured at baseline and 4 months later

• 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?).

  Measured at baseline and 4 months later

• 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

  Measured at baseline and 4 months later

Secondary Outcomes (4)

• 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 Health Care Utilization 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

Other Outcomes (4)

• Change from Baseline Partners in Health Scale at 4 months

  Measured at baseline and 4 months later

• Change from Baseline Care Values Scale at 4 months

  Measured at baseline and 4 months later

• Change from Baseline Leisure and Healthy Behaviors Scale at 4 months

  Measured at baseline and 4 months later

Study Arms (2)

SHARE for Chronic Conditions

EXPERIMENTAL

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

Health Coaching

NO INTERVENTION

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.

Interventions

SHARE-CC BEHAVIORAL

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.

SHARE for Chronic Conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Benjamin Rose Institute on Aging: lead

Study Sites (4)

Southern Caregiver Resource Center

San Diego, California, 92123, United States

Location

Family Caregiver Alliance

San Francisco, California, 94104, United States

Location

Geriatric Care Consultant

Ridgewood, New Jersey, 07459, United States

Location

Benjamin Rose Institute on Aging

Cleveland, Ohio, 44120, United States

Location

Related Publications (17)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 9386995 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18192628 BACKGROUND

• 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.

  PMID: 15933277 BACKGROUND

• 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.

  PMID: 12184513 BACKGROUND

• 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.

  PMID: 9750575 BACKGROUND

• Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.

  PMID: 649936 BACKGROUND

• 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.

  PMID: 1427280 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 5349366 BACKGROUND

• 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.

  PMID: 10028768 BACKGROUND

• 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.

  BACKGROUND

• Radloff, L.S., & Teri, L. (1986). Use of the Center for Epidemiological Studies-Depression Scale with older adults. Clinical Gerontologist, 5, 119-136.

  BACKGROUND

• 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.

  PMID: 11166528 BACKGROUND

• 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

  BACKGROUND

Study Officials

• Carol Whitlatch, PhD

  Benjamin Rose Institute on Aging

  PRINCIPAL INVESTIGATOR

• Silvia Orsulic-Jeras

  Benjamin Rose Institute on Aging

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No other parties will be masked in the trial
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Persons with chronic conditions and their family caregivers will be randomly assigned to a treatment or control group

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: September 21, 2017
• Study Start: August 15, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

US (4)