Heart Failure Caregiver Study

Not Applicable

Completed

• Conditions: Depression; Stress
• Interventions: Behavioral: Health Education; Behavioral: Cognitive Behavioral Therapy (CBT)

• Registration Number: NCT01937936
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Health Education	Health Education
CBT	Cognitive Behavioral Therapy (CBT)	Cognitive Behavioral Therapy (CBT)

Primary Outcome Measures

Name	Time	Method
Salivary cortisol	8 weeks

Secondary Outcome Measures

Name	Time	Method
Health care usage	6 months
Perceived stress	8 weeks and 6 months
Depressive symptoms	8 weeks and 6 months
Health-related quality of life	8 weeks and 6 months

Trial Locations

Locations (2)

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Medical Center, Santa Monica; 🇺🇸 Santa Monica, California, United States