Preliminary Study Examining Heart Failure Patients Responses to Depression Education

Overview

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.

Full Title of Study: “HF-ACTION Depression Education Substudy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2006

Interventions

  • Behavioral: Receiving educational material of depression care
    • The educational material provides patients about depression management

Arms, Groups and Cohorts

  • Experimental: Educational materials
    • Receiving educational materials of depression care
  • Sham Comparator: No educational materials
    • Receiving an envelope but no inclusion of educational materials of depression care

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wei Jiang, MD, Principal Investigator, Duke University

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