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Depression and Congestive Heart Failure in Outpatients.

NCT ID: NCT00321269

Last Updated: 2015-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-12-31

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

Conditions

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Heart Failure Depression

Keywords

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Home Monitoring Heart Failure Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Single Illness Management

Intervention Type BEHAVIORAL

8 week nursing intervention addressing Congestive Heart Failure

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.

Group Type EXPERIMENTAL

Comorbid Illness Management

Intervention Type BEHAVIORAL

8 week nursing intervention to address Congestive Heart Failure and emotional coping

Interventions

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Single Illness Management

8 week nursing intervention addressing Congestive Heart Failure

Intervention Type BEHAVIORAL

Comorbid Illness Management

8 week nursing intervention to address Congestive Heart Failure and emotional coping

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn L Turvey, PhD MS

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Iowa City

Locations

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Iowa City VA Medical Center

Iowa City, Iowa, United States

Site Status

Harry S. Truman Memorial VA Medical Center

Columbia, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 22933480 (View on PubMed)

Other Identifiers

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IIR 06-082

Identifier Type: -

Identifier Source: org_study_id