Heart Failure Caregiver Study
Stress and Health in Family Caregivers of Persons With Heart Failure
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedOctober 27, 2016
October 1, 2016
1.7 years
September 4, 2013
October 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Salivary cortisol
8 weeks
Secondary Outcomes (4)
Perceived stress
8 weeks and 6 months
Depressive symptoms
8 weeks and 6 months
Health-related quality of life
8 weeks and 6 months
Health care usage
6 months
Study Arms (2)
CBT
EXPERIMENTALCognitive Behavioral Therapy (CBT)
Education
ACTIVE COMPARATORHealth Education
Interventions
Family caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Being on the transplant list
- Having terminal illness (e.g., terminal cancer)
- 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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404, United States
Related Publications (1)
Hwang B, Granger DA, Brecht ML, Doering LV. Cognitive behavioral therapy versus general health education for family caregivers of individuals with heart failure: a pilot randomized controlled trial. BMC Geriatr. 2022 Apr 5;22(1):281. doi: 10.1186/s12877-022-02996-7.
PMID: 35382758DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boyoung Hwang, PhD, RN
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 4, 2013
First Posted
September 10, 2013
Study Start
September 1, 2013
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
October 27, 2016
Record last verified: 2016-10