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Chronic Health ConditionsSHARE-CCNCT03289624

SHARE for Persons With Chronic Conditions and Their Family Caregivers

A study testing SHARE-CC in people with Chronic Health Conditions and Family Caregivers, run by Benjamin Rose Institute on Aging at 4 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Health Conditions, Family Caregivers
What is being tested?
SHARE-CC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
4 sitesUnited States
Study dates
15 Aug 2017to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Benjamin Rose Institute on Aging

    Cleveland, Ohio, 44120

  • Geriatric Care Consultant

    Ridgewood, New Jersey, 07459

  • Southern Caregiver Resource Center

    San Diego, California, 92123

  • Family Caregiver Alliance

    San Francisco, California, 94104

Other trials in United States

About this study

Official title: Support, Health, Activities, Resources, and Education for Persons With Chronic Conditions and Their Family Caregivers: SHARE-Chronic Conditions (SHARE-CC)

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.

Read the 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.

Being tested
SHARE-CC
Keywords
Care Planning, Care Values and Preferences

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHARE-CCBehavioural

    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.

Study groups in NCT03289624
Study groupRoleWhat they receive
SHARE for Chronic ConditionsExperimentalSix 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.
Receives: Behavioral: SHARE-CC
Health CoachingNo interventionSix 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured at baseline and 4 months later

  2. 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: Measured at baseline and 4 months later

  3. 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: Measured at baseline and 4 months later

Secondary outcomes (4)

  1. Change from Baseline Dyadic Relationship Scale at 4 months

    The Dyadic Relationship Scale includes the Positive Dyadic Interactions and Negative Dyadic Strain subscales.

    Measured: Measured at baseline and 4 months later

  2. 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

    Measured: Measured at baseline and 4 months later

  3. 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.

    Measured: Measured at baseline and 4 months later

  4. 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.

    Measured: Measured at baseline and 4 months later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start15 Aug 2017
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Why it stopped: Lost Funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Persons with chronic conditions and their family caregivers will be randomly assigned to a treatment or control group
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03289624
Sponsor's protocol ID
2016-003
Acronym
SHARE-CC
Status last verified
Aug 2020
First submitted
18 Aug 2017
Last updated
26 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

  • 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.

    PubMed 9386995

  • 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.

  • 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.

    PubMed 18192628

  • 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.

    PubMed 15933277

  • 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.

    PubMed 12184513

  • 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.

    PubMed 9750575

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

    PubMed 649936

  • 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.

    PubMed 1427280

  • 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

  • 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.

    PubMed 5349366

  • 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.

    PubMed 10028768

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing SHARE-CC in people with Chronic Health Conditions and Family Caregivers, run by Benjamin Rose Institute on Aging at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Service Availability Measure (SAM) at 4 months (time frame: Measured at baseline and 4 months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03289624, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.

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