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Bipolar DisorderNCT00747201

Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites

A study testing Replicating Effective Programs Framework for the Bipolar Care Model and Bipolar Care Model Package Only in people with Bipolar Disorder, run by University of Michigan at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Disorder
What is being tested?
Replicating Effective Programs Framework for the Bipolar Care Model and Bipolar Care Model Package Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
384 participants
Where
3 sitesUnited States
Study dates
Sep 2009to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Washtenaw Community Health Organization

    Ann Arbor, Michigan, 48108

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Colorado-Denver

    Denver, Colorado

Other trials in United States

About this study

Official title: Implementing Chronic Care Management for Bipolar Disorder

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.

Read the detailed description

For the approximately 5.7 million Americans suffering from bipolar disorder, recurring manic and depressive symptoms, psychosis, and a high suicide risk prevent normal functioning and normal interpersonal relationships. Bipolar disorder has a high economic cost, as well, both because care for those with the disorder is expensive and because those suffering from the disorder have difficulty holding jobs. The total cost of bipolar disorder in the United States is estimated to be $45 billion. Part of this economic cost comes from poor quality of care. Only half of bipolar patients receive adequate outpatient care, and only a third receive adequate drug levels and safety monitoring. This can lead to preventable hospitalizations, emergency room use, and deaths.

Often, new results from research can take years or decades to be translated into practice in community mental health care. Even then, new methods can be less effective in practice because there is inadequate understanding of or technical support for these methods. This occurs because research is not presented in enough detail or with enough flexibility to be adapted for community settings.

The Centers for Disease Control and Prevention's (CDC's) Replicating Effective Programs (REP) project is a systematic method of replicating effective behavioral interventions for reducing HIV risk. The REP has three components:

  • Packaging, or adapting, a behavioral treatment so its scientific protocols are in nontechnical, user-friendly language
  • Providing formal training for health care professionals in implementing the package
  • Supporting the use of the package through technical assistance available to individual treatment sites

The REP framework has been effective in extending the availability of HIV behavioral interventions and ensuring proper implementation, but it has never been used for non-HIV-related interventions, nor has it been proven that wider availability of these new interventions improves patient health and quality of life. This study will examine both of these untested areas of the REP framework by packaging a new intervention for bipolar disorder, called the Bipolar Care Model (BCM). Research shows the BCM to be effective in real-world settings and across different ethnic groups. This study will determine if a packaged version of the BCM will be effective across multiple, community-based, mental health settings. Success with the packaged version of the BCM will not only make this particular treatment more available to mental health care providers, but it will create a model for transitioning all research on new behavioral interventions for mental health into effective practice.

This study will last 2 years from its first implementation to the final collection of patient data at the participating mental health care sites. The care sites that will participate in this study will be randomly assigned to receive either the BCM package, training, and technical assistance or the BCM package alone. Adherence to the BCM model and patient outcomes at each care site will be measured at baseline and after 6, 12, and 24 months. Also at these intervals, patients at each care site will be contacted for a 30-minute survey on their treatment. Care sites will be assessed on the following: adherence to the BCM model, as assessed through site records; patient clinical outcomes, as assessed through questionnaires on bipolar symptoms, functioning, and quality of life; and costs, as assessed through records of training hours, technical assistance hours, and hours spent by REP implementers. The total cost of developing the intervention according to the REP framework will also be measured.

Being tested
Replicating Effective Programs Framework for the Bipolar Care Model, Bipolar Care Model Package Only
Keywords
Replicating Effective Programs, Care Management, Implementation, Intervention
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Replicating Effective Programs Framework for the Bipolar Care ModelBehavioural

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

  • Bipolar Care Model Package OnlyBehavioural

    Health care providers will receive only the adapted manuals.

Study groups in NCT00747201
Study groupRoleWhat they receive
2 Packaged intervention onlyActive comparatorPatients will be seen by providers who receive the intervention package only.
Receives: Behavioral: Bipolar Care Model Package Only
1 Packaged intervention, training, and technical assistanceExperimentalPatients will be seen by providers who receive the packaged intervention, along with provider training and ongoing technical assistance.
Receives: Behavioral: Replicating Effective Programs Framework for the Bipolar Care Model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

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

Secondary outcomes (1)
  1. Cost-effectiveness

    Measured: Measured at 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2008 (estimated)
  2. Study startSep 2009
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00747201
Sponsor's protocol ID
R01MH079994
Other IDs
R01MH079994, DSIR 82-SEDR
Status last verified
May 2014
First submitted
4 Sep 2008
Last updated
22 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Replicating Effective Programs Framework for the Bipolar Care Model and Bipolar Care Model Package Only in people with Bipolar Disorder, run by University of Michigan at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (time frame: Change from Baseline in Quality of Life at 12-months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.

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