Clinical trial NCT01794598: Preliminary Study Examining Heart Failure Patients Responses to Depression Education
Official title: HF-ACTION Depression Education Substudy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Heart failure
depression
depression care education
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in recognition of study participant to depression care
timeFrame: Baseline, 1 month and 6 months
Secondary outcomes:
measure: Change in response of study participant to depression care
timeFrame: Baseline, 1 month, and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Wei Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: