Preliminary Study Examining Heart Failure Patients Responses to Depression Education

September 19, 2014 updated by: Duke University

HF-ACTION Depression Education Substudy

Purpose of the Study: The significant impact of depression on the poor prognosis and functional restrain, recognition and successful treatment of depression in patients with Chronic Heart Failure (CHF) may result in improvement of overall outcome of those patients. However, depression comorbid with CHF has been overlooked in the real practice. Therefore, the investigators are proposing a study to 1) assess the prognostic impact of depression in patients with stable CHF who have been managed as outpatients, and 2) assess whether provision of depression education to CHF patients will improve the care of depression.

Patients with chronic heart failure are enrolled into this study with a half of them are randomly assigned to receive a packet of depression education materials and then other half not. Participants and investigators both are blinded to the assignment. All the participants are provided a toll free phone number to contact the research team as needed. Depressive symptoms and patients knowledge of depression are assessed at baseline prior to randomization and at 1-month and 6-month following the enrollment.

Responses of the study participants, such as change of depressive symptoms, and requests for psychiatric help are examined between two groups.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion Criteria

  • LVEF ≤ 35%.
  • NYHA class II, III, or IV heart failure for the previous three months despite a minimum of 6 weeks of treatment.
  • Must be on optimal heart failure therapy according to AHA/ACC and HFSA heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation, including intolerance, contraindication, patient preference, or personal physician's judgment.

Exclusion Criteria:

  • Age less than 18.
  • Currently pregnant or intending to become pregnant in the next year.
  • Cardiovascular procedure or hospitalization for any reason planned in the next 6 months.
  • Expectation of receiving a cardiac transplant in the next six months.
  • Unable to provide the study consent.
  • Participation another clinical trial(s) that may interfere with follow-up or data collection for this study, or that may affect cardiovascular mortality.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational materials
Receiving educational materials of depression care
Behavioral: Receiving educational material of depression care
The educational material provides patients about depression management
Sham Comparator: No educational materials
Receiving an envelope but no inclusion of educational materials of depression care
Behavioral: Receiving educational material of depression care
The educational material provides patients about depression management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in recognition of study participant to depression care
Time Frame: Baseline, 1 month and 6 months
To assess whether the provision of depression education materials will increase knowledge of the impact depression has on Congestive Heart Failure patients. This will be measured through study participants completion of a questionnaire to record their views on depression and depression care in a non-psychiatric setting.
Baseline, 1 month and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in response of study participant to depression care
Time Frame: Baseline, 1 month, and 6 months
Response of participants to depression care was measured by use of the Beck Depression Inventory scale (BDI), PHQ-9 (the 9 items of the depression scale of the Patient Health Questionnaire) and an anxiety questionnaire and a toll-free contact number to access free psychiatric consultants at the coordinating center. A contact log was kept documenting subject ID, reason for call, number of contacts and duration of the call.
Baseline, 1 month, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Wei Jiang, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

February 17, 2012

First Submitted That Met QC Criteria

February 15, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Estimate)

September 22, 2014

Last Update Submitted That Met QC Criteria

September 19, 2014

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5132
  • 5132-03-8R0ER (Other Identifier: Duke legacy protocol ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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