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

January 3, 2008 updated by: University of Michigan

Improving Care for Veterans With Bipolar Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Usual Care
Experimental: 1
Behavioral Care Management
Behavioral: Disease Management
Self-management, care management, guidelines
Other Names:
  • Bipolar Care Model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health-related quality of life (SF-12)
Time Frame: 3 and 6 months
3 and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Bipolar Disorder symptoms (Internal State Scale)
Time Frame: 3 and 6 months
3 and 6 months
Functioning (WHO-DAS)
Time Frame: 3 and 6 months
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

US Department of Veterans Affairs

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 19, 2005

First Submitted That Met QC Criteria

September 19, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 4, 2008

Last Update Submitted That Met QC Criteria

January 3, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02394

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bipolar Disorder

Clinical Trials on Disease Management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe