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Depression and Congestive Heart Failure in Outpatients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00321269
First received: May 1, 2006
Last updated: November 23, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Heart Failure
Depression
Behavioral: Single Illness Management
Behavioral: Comorbid Illness Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Depression and CHF in Outpatients

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Beck Depression Inventory II [ Time Frame: Depression and psychological health will be assessed at week 1, week 8 ] [ Designated as safety issue: No ]
    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:
  • Health-Related Quality of Life [ Time Frame: Measured at week 1, week 8 ] [ Designated as safety issue: No ]
    Medical Outcomes Study SF-36 Physical Function Subscale- 10 Items Range 0 to 100, Higher Scores indicate higher functioning.


Enrollment: 134
Study Start Date: October 2007
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single Illness Managment
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.
Behavioral: Single Illness Management
8 week nursing intervention addressing Congestive Heart Failure
Experimental: 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.
Behavioral: Comorbid Illness Management
8 week nursing intervention to address Congestive Heart Failure and emotional coping

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

Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321269

Locations
United States, Iowa
Iowa City VA Medical Center
Iowa City, Iowa, United States, 52246
United States, Missouri
Harry S. Truman Memorial VA Medical Center
Columbia, Missouri, United States, 65201-5297
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Carolyn L Turvey, PhD MS VA Medical Center, Iowa City
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00321269     History of Changes
Other Study ID Numbers: IIR 06-082 
Study First Received: May 1, 2006
Results First Received: November 12, 2014
Last Updated: November 23, 2015
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Home Monitoring
Heart Failure
Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016