Heart Failure Caregiver Study

October 26, 2016 updated by: Boyoung Hwang, PhD, RN, University of California, Los Angeles

Stress and Health in Family Caregivers of Persons With Heart Failure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Santa Monica, California, United States, 90404
        • UCLA Medical Center, Santa Monica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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:
  • CBT
  • Cognitive Therapy
  • Cognitive Behavioral Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Salivary cortisol
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Perceived stress
Time Frame: 8 weeks and 6 months
8 weeks and 6 months
Depressive symptoms
Time Frame: 8 weeks and 6 months
8 weeks and 6 months
Health-related quality of life
Time Frame: 8 weeks and 6 months
8 weeks and 6 months
Health care usage
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Nursing Research (NINR)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5K23NR013475 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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