Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222755
Status:
COMPLETED
Last Update Posted:
2008-01-04
First Post:
2005-09-19
Brief Title:
Improving Care for Patients With Bipolar Disorder
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Improving Care for Veterans With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2008-01
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:
CIVIC-2
Brief Summary:
The purpose of this research study is to learn whether or not a coordinated medical and psychiatric care program can improve outcomes of care for patients with bipolar disorder We hypothesize that coordinated care via a Care Manager will improve physical and mental health-related quality of life improve functioning and reduce symptoms
Detailed Description:
Bipolar disorder is a chronic illness associated with significant personal and societal costs Patients with bipolar disorder also experience more general medical comorbidities than the general population Potential disparities exist in the receipt of medical and preventive care for individuals with serious mental illness compared to those without serious mental illness The goal of this study is to pilot test an adapted version of the Wagner Chronic Care Model CCM Our target population will be all adult patients with a diagnosis of bipolar disorder bipolar I II NOS receiving care in the VA Pittsburgh Healthcare System We plan on consenting and enrolling 60 patients in which 30 will be randomized to receive the intervention and 30 will receive usual care Key components of the intervention include 1 access to a Care Manager who will help patients make and keep appointments for general medical care by contacting patients on a regular basis 2 a self-management program which is education on adherence and self-management for patients by the Care Manager including information on side-effects bipolar disorder illness and tips on communicating with general medical providers that will be provided during group sessions during the first 3 months of the study and 3 a registry that tracks patient progress maintained by the Care Manager Both groups will receive practice guidelines for the treatment of medical conditions tailored to the needs of patients with bipolar disorder Patients in the intervention arm will meet with the Care Manager after the baseline assessment who will initially set up regular visits or contacts with the patients and work with them to connect with a primary care clinician A Survey Coordinator will have patients complete a baseline assessment and then a follow up assessment at 3 and 6 months later Our primary outcome is changes in physical and mental health related quality of life Secondary outcomes include changes in symptoms and functioning Findings from this study will inform our long-term goal of implementing a larger scale version of the adapted CCM for veterans with bipolar disorder
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