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CIVIC-2: Improving Care for Patients With Bipolar Disorder

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT00222755
Collaborator
US Department of Veterans Affairs (U.S. Fed)
60
Enrollment
1
Location
2
Arms
13.9
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Disease Management
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Improving Care for Veterans With Bipolar Disorder
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Behavioral Care Management

Behavioral: Disease Management
Self-management, care management, guidelines
Other Names:
  • Bipolar Care Model

    		•
    No Intervention: 2

    Usual Care

    Outcome Measures

    Primary Outcome Measures

    1. Health-related quality of life (SF-12) [3 and 6 months]

    Secondary Outcome Measures

    1. Bipolar Disorder symptoms (Internal State Scale) [3 and 6 months]

    2. Functioning (WHO-DAS) [3 and 6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. =18 years old

    2. active diagnosis of bipolar disorder

    3. have an assigned primary care provider in the VA, and

    4. have been seen by a provider in the Beta Team Mood Disorders clinic.

    Exclusion Criteria:

    1. actively using substances (alcohol or drugs) at the time of enrollment

    2. 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)

    3. have a terminal medical illness with <3 years expected longevity, or

    4. unable to provide informed consent for this study. (Ineligibility to be confirmed based on registry review and Survey Coordinator's assessment)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Pittsburgh Healthcare System Pittsburgh Pennsylvania United States 15240

    Sponsors and Collaborators

    • University of Michigan
    • US Department of Veterans Affairs

    Investigators

    • Principal Investigator: Amy M Kilbourne, PhD, University of Michigan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00222755
    Other Study ID Numbers:
    • 02394
    First Posted:
    Sep 22, 2005
    Last Update Posted:
    Jan 4, 2008
    Last Verified:
    Jan 1, 2008
    Keywords provided by , ,
    Mood disorders-bipolar
    Disease management
    Quality of care
    Additional relevant MeSH terms:
    Disease
    Bipolar Disorder

    Study Results

    No Results Posted as of Jan 4, 2008