Heart Failure Caregiver Study

N/ACompletedNCT01937936

University of California, Los Angeles50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Stress Depression

Interventions

Cognitive Behavioral Therapy (CBT)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.

Health EducationBEHAVIORAL

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

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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)

Locations (2)

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UCLA Medical Center, Santa Monica

Santa Monica, California, United States

Outcomes

Primary Outcomes

Salivary cortisol

Time frame: 8 weeks

Secondary Outcomes

Perceived stress

Time frame: 8 weeks and 6 months

Depressive symptoms

Time frame: 8 weeks and 6 months

Health-related quality of life

Time frame: 8 weeks and 6 months

Health care usage

Time frame: 6 months

Data from ClinicalTrials.gov

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