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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00847132 |
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:
Condition | Intervention |
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Coronary Artery Disease Congestive Heart Failure Arrhythmia Depression |
Behavioral: Collaborative care vs. usual care |
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 |
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 |
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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
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Behavioral: Collaborative care vs. usual care
depression education, treatment recommendations, coordination of care
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Usual care: Active Comparator
Primary medical providers are informed that the patient has depression and that treatment is recommended.
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Behavioral: Collaborative care vs. usual care
depression education, treatment recommendations, coordination of care
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeff C Huffman, MD | 617-724-2910 | jhuffman@partners.org |
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 |
Principal Investigator: | Jeff C Huffman, MD | Massachusetts General Hospital |
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 |
Collaborative Care |
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 |
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 |