Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321269
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2006-05-01
Brief Title:
Depression and Congestive Heart Failure in Outpatients
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Depression and CHF in Outpatients
Status:
COMPLETED
Status Verified Date:
2015-11
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:
Patients with a diagnosis of CHF NYHA class II III or IV will be recruited for a study comparing a nursing intervention addressing CHF SIM group or CHF and depression CIM group Participants in the standard illness management program will receive an 8-week 8-session intervention designed to help them improve daily weighing salt-restriction medication management etc This intervention will be conducted in a combination of home visits and phone visits They will also receive interactive telephone-based daily monitoring that assesses daily weight dyspnea fatigue and medication compliance Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness The comorbid illness management home monitoring will include a twice-monthly screen for depression Major Variables The major outcomes will be depressive symptoms health-related quality of life functional status heart failure symptom severity and self-care behaviors in heart failure
Detailed Description:
Background
Between 4 and 5 of patients seen at Veterans Affairs Medical Centers suffer heart failure HF is the number one discharge diagnosis within the VHA One of the most significant comorbidities in heart failure is depression Depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators This HSRD study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure
Objectives
To demonstrate better depression health-related quality-of-life and adherence outcomes for an illness management combined with psychotherapy intervention COMBO as compared to an illness management alone program IMO
Methods
This was a two-site two-arm randomized controlled trial comparing COMBO to IMO The total number of patients recruited for the study was 148 Retention was comparable between groups though depression severity predicted drop out in the IMO condition but not the COMBO condition Patients completed study assessments at baseline week 4 week 8 post-intervention and at 26- and 52-week follow-up
Status
The main study analyses have been conducted The project team is conducting analysis of secondary hypotheses
Between 4 and 5 of patients seen at Veterans Affairs Medical Centers suffer heart failure HF is the number one discharge diagnosis within the VHA One of the most significant comorbidities in heart failure is depression Depression predicts increased hospitalization and mortality even after controlling for key prognostic indicators This HSRD study aimed to test the effectiveness of a psychotherapy intervention for depression combined with illness management to illness management alone in veterans with heart failure
Objectives
To demonstrate better depression health-related quality-of-life and adherence outcomes for an illness management combined with psychotherapy intervention COMBO as compared to an illness management alone program IMO
Methods
This was a two-site two-arm randomized controlled trial comparing COMBO to IMO The total number of patients recruited for the study was 148 Retention was comparable between groups though depression severity predicted drop out in the IMO condition but not the COMBO condition Patients completed study assessments at baseline week 4 week 8 post-intervention and at 26- and 52-week follow-up
Status
The main study analyses have been conducted The project team is conducting analysis of secondary hypotheses
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