Clinical trial NCT00321269: Depression and Congestive Heart Failure in Outpatients.
Official title: Depression and CHF in Outpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Depression
Keywords: Home Monitoring
Heart Failure
Depression
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-05-03
Enrollment: 134
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM group). Participants in the standard illness management program will receive an 8-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. This intervention will be conducted in a combination of home visits and phone visits. They will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness. The comorbid illness management home monitoring will include a twice-monthly screen for depression. Major Variables: The major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure.

Detailed description: Background:

Between 4 and 5% of patients seen at Veterans Affairs Medical Centers suffer heart failure. HF is the number one discharge diagnosis within the VHA. One of the most significant comorbidities in heart failure is depression. Depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators. This HSR\&D study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure.

Objectives:

To demonstrate better depression, health-related quality-of-life, and adherence outcomes for an illness management combined with psychotherapy intervention (COMBO) as compared to an illness management alone program (IMO).

Methods:

This was a two-site, two-arm, randomized controlled trial comparing COMBO to IMO. The total number of patients recruited for the study was 148. Retention was comparable between groups, though depression severity predicted drop out in the IMO condition but not the COMBO condition. Patients completed study assessments at baseline, week 4, week 8 (post-intervention) and at 26- and 52-week follow-up.

Status:

The main study analyses have been conducted. The project team is conducting analysis of secondary hypotheses

Eligibility criteria: Inclusion Criteria:

* Receiving treatment for NYHA Class 2-4 heart failure.
* Patients of the Iowa City, IA or Columbia, MO Veterans Affairs Medical Center Primary Care or Cardiac Care Clinics.
* Life expectancy greater than 6 months.
* Must speak English.
* Must possess a working telephone.

Exclusion Criteria:

* Presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (PTSD patients are eligible).
* Life expectancy less than 3 months.
* Planned relocation to a nursing home.
* Marked visual or hearing impairment.

Primary outcomes:
measure: Beck Depression Inventory II
timeFrame: Depression and psychological health will be assessed at week 1, week 8
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Measured at week 1, week 8
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa City VA Medical Center
state: Iowa
city: Columbia
country: United States
facility: Harry S. Truman Memorial VA Medical Center
state: Missouri
Study officials:
affiliation: VA Medical Center, Iowa City
name: Carolyn L Turvey, PhD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turvey C, Sheeran T, Dindo L, Wakefield B, Klein D. Validity of the Patient Health Questionnaire, PHQ-9, administered through interactive-voice-response technology. J Telemed Telecare. 2012 Sep;18(6):348-51. doi: 10.1258/jtt.2012.120220. Epub 2012 Aug 29.