Clinical trial NCT01937936: Heart Failure Caregiver Study
Official title: Stress and Health in Family Caregivers of Persons With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Depression
Keywords: caregiver stress
depression
quality of life
cognitive behavioral therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2013-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Salivary cortisol
timeFrame: 8 weeks
Secondary outcomes:
measure: Perceived stress
timeFrame: 8 weeks and 6 months
measure: Depressive symptoms
timeFrame: 8 weeks and 6 months
measure: Health-related quality of life
timeFrame: 8 weeks and 6 months
measure: Health care usage
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Santa Monica
country: United States
facility: UCLA Medical Center, Santa Monica
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Boyoung Hwang, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.