NCT00222755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 4, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

September 19, 2005

Last Update Submit

January 3, 2008

Conditions

Bipolar Disorder

Keywords

Mood disorders-bipolarDisease managementQuality of care

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life (SF-12)

    3 and 6 months

Secondary Outcomes (2)

  • Bipolar Disorder symptoms (Internal State Scale)

    3 and 6 months

  • Functioning (WHO-DAS)

    3 and 6 months

Study Arms (2)

1

EXPERIMENTAL

Behavioral Care Management

Behavioral: Disease Management

2

NO INTERVENTION

Usual Care

Interventions

Disease ManagementBEHAVIORAL

Self-management, care management, guidelines

Also known as: Bipolar Care Model
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>=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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • Amy M Kilbourne, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

January 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 4, 2008

Record last verified: 2008-01

Locations

US(1)