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Improving Care for Patients With Bipolar Disorder (CIVIC-2)

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Disease Management
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Mood disorders-bipolar, Disease management, Quality of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: >=18 years old active diagnosis of bipolar disorder have an assigned primary care provider in the VA, and have been seen by a provider in the Beta Team Mood Disorders clinic. Exclusion Criteria: actively using substances (alcohol or drugs) at the time of enrollment already enrolled in a mental health program with a mobile outreach component in which clinical caregivers deliver services to the patient in the community (e.g., Assertive Community Treatment or Intensive Case Management) have a terminal medical illness with <3 years expected longevity, or unable to provide informed consent for this study. (Ineligibility to be confirmed based on registry review and Survey Coordinator's assessment)

Sites / Locations

  • VA Pittsburgh Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Behavioral Care Management

Usual Care

Outcomes

Primary Outcome Measures

Health-related quality of life (SF-12)

Secondary Outcome Measures

Bipolar Disorder symptoms (Internal State Scale)
Functioning (WHO-DAS)

Full Information

First Posted
September 19, 2005
Last Updated
January 3, 2008
Sponsor
University of Michigan
Collaborators
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00222755
Brief Title
Improving Care for Patients With Bipolar Disorder
Acronym
CIVIC-2
Official Title
Improving Care for Veterans With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan
Collaborators
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Mood disorders-bipolar, Disease management, Quality of care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral Care Management
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Disease Management
Other Intervention Name(s)
Bipolar Care Model
Intervention Description
Self-management, care management, guidelines
Primary Outcome Measure Information:
Title
Health-related quality of life (SF-12)
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
Bipolar Disorder symptoms (Internal State Scale)
Time Frame
3 and 6 months
Title
Functioning (WHO-DAS)
Time Frame
3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: >=18 years old active diagnosis of bipolar disorder have an assigned primary care provider in the VA, and have been seen by a provider in the Beta Team Mood Disorders clinic. Exclusion Criteria: actively using substances (alcohol or drugs) at the time of enrollment already enrolled in a mental health program with a mobile outreach component in which clinical caregivers deliver services to the patient in the community (e.g., Assertive Community Treatment or Intensive Case Management) have a terminal medical illness with <3 years expected longevity, or unable to provide informed consent for this study. (Ineligibility to be confirmed based on registry review and Survey Coordinator's assessment)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M Kilbourne, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

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Improving Care for Patients With Bipolar Disorder

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