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A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, February 2009
First Received: February 17, 2009   No Changes Posted
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00847132
  Purpose

Depression in cardiac patients is common, persistent, and deadly. However, the vast majority of cardiac patients with depression go unrecognized and untreated, despite the existence of treatments that clearly improve depressive symptoms and may favorably impact survival. Our research group and others have found that depression recognition and treatment appears particularly limited among patients with acute cardiac illness, though this population may be the most vulnerable to the deleterious effects of depression. We propose a project, building on successful collaborative care depression management programs in outpatient settings, to address this important issue.

The specific hypotheses behind the proposed research are that a collaborative care depression management program can be successfully adapted to inpatient cardiac units, and that such a program will lead to greater rates of adequate depression treatment and improvements in secondary outcomes.

The following specific aims capture the stepwise goals of this program:

  1. To determine whether a collaborative care depression management program ('Enhanced Care') leads to significantly increased rates of adequate depression treatment compared to usual care (screening and feedback) (Primary Aim).
  2. To assess whether this Enhanced Care program has a lasting impact on adequate depression treatment, depressive symptoms, health-related quality of life, and adherence to medical recommendations at 1, 3, 6, and 12 months, compared to usual care.

Condition Intervention
Coronary Artery Disease
Congestive Heart Failure
Arrhythmia
Depression
Behavioral: Collaborative care vs. usual care

Genetics Home Reference related topics: Brugada syndrome short QT syndrome
MedlinePlus related topics: Arrhythmia Coronary Artery Disease Depression Heart Failure
U.S. FDA Resources
Study Type: Interventional
Study Design: Health Services Research, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Rates of adequate depression treatment at discharge [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depressive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: July 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Collaborative care: Experimental
A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations
Behavioral: Collaborative care vs. usual care
depression education, treatment recommendations, coordination of care
Usual care: Active Comparator
Primary medical providers are informed that the patient has depression and that treatment is recommended.
Behavioral: Collaborative care vs. usual care
depression education, treatment recommendations, coordination of care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inpatient admission for cardiac diagnosis
  • Positive depression evaluation (PHQ-2>2, PHQ-9>9)
  • Ability to provide informed consent

Exclusion Criteria:

  • Active suicidal ideation
  • Bipolar disorder, psychotic disorder, active substance use disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847132

Contacts
Contact: Jeff C Huffman, MD 617-724-2910 jhuffman@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeff Huffman, MD     617-724-2910     jhuffman@partners.org    
Sub-Investigator: James L Januzzi, MD            
Sub-Investigator: Curtis Wittmann, MD            
Sub-Investigator: Carol Mastromauro, LICSW            
Sub-Investigator: Felicia A Smith, MD            
Sub-Investigator: Gregory L Fricchione, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jeff C Huffman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: American Heart Association ( Jacqueline French )
Study ID Numbers: 0735530T
Study First Received: February 17, 2009
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00847132     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Collaborative Care

Study placed in the following topic categories:
Arterial Occlusive Diseases
Heart Failure
Depression
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Arteriosclerosis
Depressive Disorder
Behavioral Symptoms
Coronary Disease
Mental Disorders
Mood Disorders
Coronary Artery Disease
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Heart Failure
Depression
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Depressive Disorder
Behavioral Symptoms
Coronary Disease
Pathologic Processes
Mental Disorders
Mood Disorders
Cardiovascular Diseases
Coronary Artery Disease
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009