Depression and Congestive Heart Failure in Outpatients.

Depression Clinical Trial

Official title:

Depression and CHF in Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321269
• Other study ID #: IIR 06-082
• Status: Completed
• Phase: N/A
• First received: May 1, 2006
• Last updated: November 23, 2015
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: November 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Heart Failure

Intervention

Behavioral:
• Single Illness Management
8 week nursing intervention addressing Congestive Heart Failure
• Comorbid Illness Management
8 week nursing intervention to address Congestive Heart Failure and emotional coping

Locations

Country	Name	City	State
United States	Harry S. Truman Memorial VA Medical Center	Columbia	Missouri
United States	Iowa City VA Medical Center	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory II	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.	Depression and psychological health will be assessed at week 1, week 8	No
Secondary	Health-Related Quality of Life	Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.	Measured at week 1, week 8	No