Improving Care for Patients With Bipolar Disorder

Bipolar Disorder Clinical Trial

— CIVIC-2  

Official title:

Improving Care for Veterans With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00222755
• Other study ID #: 02394
• Status: Completed
• Phase: N/A
• First received: September 19, 2005
• Last updated: January 3, 2008
• Start date: January 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2008
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Disease Management
Self-management, care management, guidelines

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life (SF-12)		3 and 6 months	No
Secondary	Bipolar Disorder symptoms (Internal State Scale)		3 and 6 months	No
Secondary	Functioning (WHO-DAS)		3 and 6 months	No