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Heart Failure Caregiver Study

Primary Purpose

Stress, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Health Education
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring caregiver stress, depression, quality of life, cognitive behavioral therapy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ronald Reagan UCLA Medical Center
  • UCLA Medical Center, Santa Monica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT

Education

Arm Description

Cognitive Behavioral Therapy (CBT)

Health Education

Outcomes

Primary Outcome Measures

Salivary cortisol

Secondary Outcome Measures

Perceived stress
Depressive symptoms
Health-related quality of life
Health care usage

Full Information

First Posted
September 4, 2013
Last Updated
October 26, 2016
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01937936
Brief Title
Heart Failure Caregiver Study
Official Title
Stress and Health in Family Caregivers of Persons With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Depression
Keywords
caregiver stress, depression, quality of life, cognitive behavioral therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy (CBT)
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Health Education
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Other Intervention Name(s)
Cognitive Therapy, Cognitive Behavioral Intervention, CBT
Intervention Description
Family caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Salivary cortisol
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Perceived stress
Time Frame
8 weeks and 6 months
Title
Depressive symptoms
Time Frame
8 weeks and 6 months
Title
Health-related quality of life
Time Frame
8 weeks and 6 months
Title
Health care usage
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boyoung Hwang, PhD, RN
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Medical Center, Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35382758
Citation
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.
Results Reference
derived

Learn more about this trial

Heart Failure Caregiver Study

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