NCT01794598

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2004

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2012

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
Last Updated

September 22, 2014

Status Verified

February 1, 2013

Enrollment Period

2.6 years

First QC Date

February 17, 2012

Last Update Submit

September 19, 2014

Conditions

Chronic Heart Failure

Keywords

Heart failuredepressiondepression care education

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change in response of study participant to depression care

    Baseline, 1 month, and 6 months

Study Arms (2)

Educational materials

EXPERIMENTAL

Receiving educational materials of depression care

Behavioral: Receiving educational material of depression care

No educational materials

SHAM COMPARATOR

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

Behavioral: Receiving educational material of depression care

Interventions

Receiving educational material of depression careBEHAVIORAL

The educational material provides patients about depression management

Educational materialsNo educational materials

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureDepression

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Study Officials

  • Wei Jiang, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2012

First Posted

February 20, 2013

Study Start

May 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 22, 2014

Record last verified: 2013-02