Preliminary Study Examining Heart Failure Patients Responses to Depression Education

NCT ID: NCT01794598

Last Updated: 2014-09-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2006-12-31

Brief Summary

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.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

Educational materials

Receiving educational materials of depression care

Group Type: EXPERIMENTAL

Receiving educational material of depression care

Intervention Type: BEHAVIORAL

The educational material provides patients about depression management

No educational materials

Receiving an envelope but no inclusion of educational materials of depression care

Group Type: SHAM_COMPARATOR

Receiving educational material of depression care

Intervention Type: BEHAVIORAL

The educational material provides patients about depression management

Interventions

Receiving educational material of depression care

The educational material provides patients about depression management

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

5132-03-8R0ER

Identifier Type: OTHER

Identifier Source: secondary_id

5132

Identifier Type: -

Identifier Source: org_study_id