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View Clinical Trial (Medical Research Study)
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Adapting the Bipolar Care Model for Chronic Care Management in Community-based Health Care Sites - NCT00747201-48109 (Clinical Trial 240463)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy240463.aspx
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| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48109 |
| Conditions: |
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Bipolar Disorder |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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Inclusion Criteria:
- 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)
Exclusion Criteria:
- Serious illness that would prevent participation in the BCM components as indicated
by the provider
- Living in a nursing home or other institution |
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| Study is available at: |
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University of Michigan
Ann Arbor, MI 48109
United States
Primary Contact:
Amy M. Kilbourne, PhD, MPH
Email: amykilbo@umich.edu
Phone: 734-845-5046
Secondary Contact:
Amy R. Burghardt, MPH
Email: aburghar@umich.edu
Phone: 734-615-7001 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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