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Heart Failure Caregiver Study

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT01937936
Collaborator
National Institute of Nursing Research (NINR) (NIH)
50
Enrollment
2
Locations
2
Arms
19.9
Duration (Months)
25
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Family caregivers are vulnerable to health problems because of the stress and demands of their role as a caregiver. With the growing incidence of heart failure (HF) and the anticipated growth in the aging population, the number of HF caregivers is expected to rise. This study will pilot test a cognitive behavioral intervention designed to reduce stress among HF caregivers, which will ultimately contribute to promoting health and quality of life among HF caregivers and their loved ones with HF.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy (CBT)
  • Behavioral: Health Education
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Stress and Health in Family Caregivers of Persons With Heart Failure
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBT

Cognitive Behavioral Therapy (CBT)

Behavioral: Cognitive Behavioral Therapy (CBT)
Family caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home.
Other Names:
  • Cognitive Therapy
  • Cognitive Behavioral Intervention
  • CBT

    		•
    Active Comparator: Education

    Health Education

    Behavioral: Health Education
    Family caregivers in the Education group will receive 8 1-hour weekly sessions of general health education on selected topics, which will take place in their home.

    Outcome Measures

    Primary Outcome Measures

    1. Salivary cortisol [8 weeks]

    Secondary Outcome Measures

    1. Perceived stress [8 weeks and 6 months]

    2. Depressive symptoms [8 weeks and 6 months]

    3. Health-related quality of life [8 weeks and 6 months]

    4. Health care usage [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Patient Inclusion Criteria:

    • 21 years or older

    • Having primary or secondary diagnosis of HF (NYHA class II-IV)

    • Having a family member or friend providing care for them at home

    • Being able to communicate in English

    Patient Exclusion Criteria:

    • Being on the transplant list

    • Having terminal illness (e.g., terminal cancer)

    Caregiver Inclusion Criteria:

    • 21 years or older

    • Having the primary responsibility for the care of the patient for at least 6 months

    • Living in the greater Los Angeles area

    • Being able to communicate in English

    Caregiver Exclusion Criteria:

    • Being a paid caregiver (an individual who is hired to provide care for the patient)

    • Having terminal illness (e.g., terminal cancer) or a serious medical condition that requires ongoing medical care (e.g., cancer requiring ongoing chemotherapy or radiation therapy)

    • Having a history of major psychiatric illness (i.e., schizophrenia, bipolar disorder, and/or any personality disorder)

    • Diagnosed with Cushing's or Addison's disease

    • Taking medication that could influence cortisol levels (e.g., steroid based anti-inflammatory drugs)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ronald Reagan UCLA Medical Center Los Angeles California United States 90095
    2 UCLA Medical Center, Santa Monica Santa Monica California United States 90404

    Sponsors and Collaborators

    • University of California, Los Angeles
    • National Institute of Nursing Research (NINR)

    Investigators

    • Principal Investigator: Boyoung Hwang, PhD, RN, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boyoung Hwang, PhD, RN, Assistant Professor, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT01937936
    Other Study ID Numbers:
    • 5K23NR013475
    • 5K23NR013475
    First Posted:
    Sep 10, 2013
    Last Update Posted:
    Oct 27, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Boyoung Hwang, PhD, RN, Assistant Professor, University of California, Los Angeles
    caregiver stress
    depression
    quality of life
    cognitive behavioral therapy
    Additional relevant MeSH terms:
    Heart Failure
    Depression

    Study Results

    No Results Posted as of Oct 27, 2016