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| Sponsor: | 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:
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease Congestive Heart Failure Arrhythmia Depression |
Behavioral: Collaborative care vs. usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | A Collaborative Care Program to Improve Depression Treatment in Cardiac Patients |
| Enrollment: | 175 |
| Study Start Date: | July 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Collaborative care
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
|
|
Active Comparator: Usual care
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Jeff C Huffman, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Jeff C Huffman, MD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00847132 History of Changes |
| Other Study ID Numbers: | 2007P-001152 |
| Study First Received: | February 17, 2009 |
| Last Updated: | November 29, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Collaborative Care |
|
Arrhythmias, Cardiac Coronary Artery Disease Myocardial Ischemia Coronary Disease Depression Depressive Disorder Heart Failure Heart Diseases |
Cardiovascular Diseases Pathologic Processes Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Behavioral Symptoms Mood Disorders Mental Disorders |