Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091962
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2004-09-20
Brief Title:
Effectiveness of Depression Treatment Following Coronary Artery Bypass Surgery
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Treatment of Depression Following Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to treat depression in patients who have undergone coronary artery bypass graft CABG
Detailed Description:
BACKGROUND
Cardiovascular disease morbidity and mortality is an important health issue Depression has emerged as a risk factor for increased morbidity and mortality in patients with coronary heart disease CABG is a surgical procedure that is specifically directed to improvement in quality of life for patients with severe coronary artery disease though its impact on mortality is questionable Patients with depression after CABG are found to not demonstrate sufficient improvement in quality of life resulting in a significantly higher level of healthcare costs
DESIGN NARRATIVE
In this randomized study 300 patients who show elevated levels of depressive symptoms at 3 to 5 days following CABG and at 2 weeks after hospital discharge will be recruited They will be randomized to receive either 1 their physicians usual care for depression or 2 a stepped collaborative care program involving a telephone-based nurse care manager The nurse care manager will contact patients at regular intervals to assess treatment preferences for depression eg counseling self-management workbook pharmacotherapy or specialty referral promote adherence with care and monitor the therapeutic response in concert with patients primary care physicians and under the supervision of a study clinician One hundred and fifty nondepressed post-CABG patients will be randomly selected to serve as a control cohort to facilitate comparisons with the depressed patients on various baseline and follow-up measures and to better understand the benefits derived from depression treatment total N450 Blinded telephone assessments will be conducted at 2 4 8 and 12 months post CABG and then every 6 months until the last patient completes hisher 8-month assessment range 8-44 months follow-up Intent-to-treat analyses will be used to test the primary hypothesis that the intervention will produce at least a clinically meaningful 05 effect size improvement in health related quality of life HRQoL at 8 months post CABG as measured by the SF-36 Mental Component Summary score compared to patients who receive their primary care physicians usual care for depression The secondary hypotheses are that compared to usual care patients intervention patients will 1 experience higher levels of functional status and lower levels of depressive symptoms risk for future cardiovascular events and health services costs and 2 report similar levels of HRQoL as nondepressed post-CABG patients Providing evidence-based stepped collaborative care treatment for post-CABG depression may be an ideal method for organized health care delivery systems to improve outcomes The focus on HRQoL and health services costs will facilitate comparisons of the benefits derived from the intervention to that of other established treatments of cardiovascular risk factors and care for other chronic conditions
Cardiovascular disease morbidity and mortality is an important health issue Depression has emerged as a risk factor for increased morbidity and mortality in patients with coronary heart disease CABG is a surgical procedure that is specifically directed to improvement in quality of life for patients with severe coronary artery disease though its impact on mortality is questionable Patients with depression after CABG are found to not demonstrate sufficient improvement in quality of life resulting in a significantly higher level of healthcare costs
DESIGN NARRATIVE
In this randomized study 300 patients who show elevated levels of depressive symptoms at 3 to 5 days following CABG and at 2 weeks after hospital discharge will be recruited They will be randomized to receive either 1 their physicians usual care for depression or 2 a stepped collaborative care program involving a telephone-based nurse care manager The nurse care manager will contact patients at regular intervals to assess treatment preferences for depression eg counseling self-management workbook pharmacotherapy or specialty referral promote adherence with care and monitor the therapeutic response in concert with patients primary care physicians and under the supervision of a study clinician One hundred and fifty nondepressed post-CABG patients will be randomly selected to serve as a control cohort to facilitate comparisons with the depressed patients on various baseline and follow-up measures and to better understand the benefits derived from depression treatment total N450 Blinded telephone assessments will be conducted at 2 4 8 and 12 months post CABG and then every 6 months until the last patient completes hisher 8-month assessment range 8-44 months follow-up Intent-to-treat analyses will be used to test the primary hypothesis that the intervention will produce at least a clinically meaningful 05 effect size improvement in health related quality of life HRQoL at 8 months post CABG as measured by the SF-36 Mental Component Summary score compared to patients who receive their primary care physicians usual care for depression The secondary hypotheses are that compared to usual care patients intervention patients will 1 experience higher levels of functional status and lower levels of depressive symptoms risk for future cardiovascular events and health services costs and 2 report similar levels of HRQoL as nondepressed post-CABG patients Providing evidence-based stepped collaborative care treatment for post-CABG depression may be an ideal method for organized health care delivery systems to improve outcomes The focus on HRQoL and health services costs will facilitate comparisons of the benefits derived from the intervention to that of other established treatments of cardiovascular risk factors and care for other chronic conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070000 | NIH | None | httpsreporternihgovquickSearchR01HL070000 |