Depression and Congestive Heart Failure in Outpatients.

Study Overview
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Brief Summary
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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
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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

Official Title
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Depression and CHF in Outpatients

Conditions
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Heart Failure, Depression

Intervention / Treatment
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* Behavioral: Single Illness Management
* Behavioral: Comorbid Illness Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Illness Managment<br>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<br>* 8 week nursing intervention addressing Congestive Heart Failure<br>|
| Experimental: Comorbid Illness Management<br>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<br>* 8 week nursing intervention to address Congestive Heart Failure and emotional coping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Monitoring, Heart Failure, Depression