Suspended

Depression Education Impact on Chronic Heart Failure Patients

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Study Aim

This study aims to evaluate if providing depression education materials can enhance your understanding of depression's impact on individuals with Congestive Heart Failure, as measured through a questionnaire.

What is being tested

Receiving educational material of depression care

+ Receiving educational material of depression care

Behavioral
Who is being recruted

Behavior+3

+ Behavioral Symptoms

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Placebo-Controlled
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorDuke University
Last updated: September 22, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

This study focuses on understanding the impact of depression on individuals with Chronic Heart Failure (CHF). It's known that depression can worsen the outlook and limit daily activities for people with CHF. However, depression often goes unnoticed in these patients. The study aims to evaluate how depression affects the prognosis of stable CHF patients receiving outpatient care. Additionally, it explores whether providing depression education to CHF patients can enhance their depression care. In this study, patients with chronic heart failure are enrolled and half of them are randomly selected to receive a packet of depression education materials, while the other half do not. Both participants and researchers are unaware of who receives the materials. All participants can contact the research team using a toll-free number whenever needed. Depressive symptoms and patients' understanding of depression are evaluated at the start, then 1-month and 6-months after enrollment. The study examines changes in depressive symptoms and requests for psychiatric help between the two groups.

NCT01794598
Principal SponsorDuke University
Last updated: September 22, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

270 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsCardiovascular DiseasesHeart DiseasesDepressionHeart Failure

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Receiving educational materials of depression care

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers