Heart Failure Caregiver Study

NCT ID: NCT01937936

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stress Depression

Keywords

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caregiver stress depression quality of life cognitive behavioral therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CBT

Cognitive Behavioral Therapy (CBT)

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

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

Education

Health Education

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Therapy Cognitive Behavioral Intervention CBT

Eligibility Criteria

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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


* 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

Exclusion Criteria

* Being on the transplant list
* Having terminal illness (e.g., terminal cancer)


* 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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Boyoung Hwang, PhD, RN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Boyoung Hwang, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

UCLA Medical Center, Santa Monica

Santa Monica, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35382758 (View on PubMed)

Other Identifiers

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5K23NR013475

Identifier Type: NIH

Identifier Source: secondary_id

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5K23NR013475

Identifier Type: NIH

Identifier Source: org_study_id

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