Preliminary Study Examining Heart Failure Patients Responses to Depression Education

Chronic Heart Failure Clinical Trial

Official title:

HF-ACTION Depression Education Substudy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01794598
• Other study ID #: 5132
• Secondary ID: 5132-03-8R0ER
• Status: Terminated
• Phase: N/A
• First received: February 17, 2012
• Last updated: September 19, 2014
• Start date: May 2004
• Est. completion date: December 2006

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 270
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Chronic Heart Failure
• Depression
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in recognition of study participant to depression care	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	No
Secondary	Change in response of study participant to depression care	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	No