Depression and Congestive Heart Failure in Outpatients.

Not Applicable

Completed

• Conditions: Heart Failure; Depression
• Interventions: Behavioral: Single Illness Management; Behavioral: Comorbid Illness Management

• Registration Number: NCT00321269
• Lead Sponsor: VA Office of Research and Development

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

Study Timeline

• Study First Submitted: 2006-05-01
• Study First Submitted QC: 2006-05-01
• Study First Posted: 2006-05-03
• Study Start: 2007-10
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Results First Submitted: 2014-11-12
• Results First Submitted QC: 2015-09-21
• Results First Posted: 2015-10-21
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Illness Managment	Single Illness Management	This intervention includes standard disease self-management coaching for heart failure and helps patients set goals for fluid management, restricted salt-intake, and medication adherence.
Comorbid Illness Management	Comorbid Illness Management	This intervention includes the same self-management coaching found in the comparator arm, but also includes discussion of ways to cope and manage mood.

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory II	Depression and psychological health will be assessed at week 1, week 8	Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	Measured at week 1, week 8	Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.

Trial Locations

Locations (2)

Harry S. Truman Memorial VA Medical Center; 🇺🇸 Columbia, Missouri, United States

Iowa City VA Medical Center; 🇺🇸 Iowa City, Iowa, United States