NCT00747201

Brief Summary

This study will determine if a version of the bipolar care model adapted for a nonresearch audience can improve patient health and correct use of the model in community-based mental health care sites.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 22, 2014

Status Verified

May 1, 2014

Enrollment Period

4.5 years

First QC Date

September 4, 2008

Last Update Submit

May 21, 2014

Conditions

Keywords

Replicating Effective ProgramsCare ManagementImplementationIntervention

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Change from Baseline in Quality of Life at 12-months.

Secondary Outcomes (1)

  • Cost-effectiveness

    Measured at 12-months

Study Arms (2)

2 Packaged intervention only

ACTIVE COMPARATOR

Patients will be seen by providers who receive the intervention package only.

Behavioral: Bipolar Care Model Package Only

1 Packaged intervention, training, and technical assistance

EXPERIMENTAL

Patients will be seen by providers who receive the packaged intervention, along with provider training and ongoing technical assistance.

Behavioral: Replicating Effective Programs Framework for the Bipolar Care Model

Interventions

Health care providers will receive adapted manuals, training, and technical assistance in the bipolar care model.

1 Packaged intervention, training, and technical assistance

Health care providers will receive only the adapted manuals.

2 Packaged intervention only

Eligibility Criteria

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

You may qualify if:

  • Currently being seen as a patient at the participating site
  • Active diagnosis or treatment plan for Bipolar I, Bipolar II, or Bipolar not otherwise specified (NOS)

You may not qualify if:

  • Serious illness that would prevent participation in the BCM components as indicated by the provider
  • Living in a nursing home or other institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Colorado-Denver

Denver, Colorado, United States

Location

Washtenaw Community Health Organization

Ann Arbor, Michigan, 48108, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Amy M. Kilbourne, PhD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 5, 2008

Study Start

September 1, 2009

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 22, 2014

Record last verified: 2014-05

Locations