Heart Failure Caregiver Study

Depression Clinical Trial

Official title:

Stress and Health in Family Caregivers of Persons With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937936
• Other study ID #: 5K23NR013475
• Secondary ID: 5K23NR013475
• Status: Completed
• Phase: N/A
• First received: September 4, 2013
• Last updated: October 26, 2016
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Heart Failure
• Stress

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA Medical Center, Santa Monica	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary cortisol		8 weeks	No
Secondary	Perceived stress		8 weeks and 6 months	No
Secondary	Depressive symptoms		8 weeks and 6 months	No
Secondary	Health-related quality of life		8 weeks and 6 months	No
Secondary	Health care usage		6 months	No