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OpenTrials
Completed

NCT Number: NCT01937936

Heart Failure Caregiver Study

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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Caregiver Burden Depression Stress, Psychological

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Cognitive Therapy, Cognitive Behavioral Intervention, CBT

Health Education

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.

Primary outcomes

  1. Salivary cortisol

    Time frame: 8 weeks

Secondary outcomes

  1. Perceived stress

    Time frame: 8 weeks and 6 months

  2. Depressive symptoms

    Time frame: 8 weeks and 6 months

  3. Health-related quality of life

    Time frame: 8 weeks and 6 months

  4. Health care usage

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Stress and Health in Family Caregivers of Persons With Heart Failure

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2013
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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