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Self-Management Addressing Heart Disease Risk Trial (SMAHRT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00499096
First received: July 9, 2007
Last updated: November 12, 2014
Last verified: November 2014
Results First Received: October 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions: Bipolar Disorder
Cardiovascular Disease
Intervention: Behavioral: Chronic care model for Bipolar Disorder

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Chronic Care Model for Bipolar Disorder

An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.

Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.

Enhanced Usual Care A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.

Participant Flow:   Overall Study
    Chronic Care Model for Bipolar Disorder     Enhanced Usual Care  
STARTED     58     60  
COMPLETED     35     40  
NOT COMPLETED     23     20  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Chronic Care Model for Bipolar Disorder

An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease (CVD); group will receive self-management group sessions, followed by phone contacts by the Care Manager.

Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care.

Enhanced Usual Care A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease (CVD) will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
Total Total of all reporting groups

Baseline Measures
    Chronic Care Model for Bipolar Disorder     Enhanced Usual Care     Total  
Number of Participants  
[units: participants]
  58     60     118  
Age  
[units: years]
Mean ± Standard Deviation
  53.1  ± 10.6     52.4  ± 9.2     52.8  ± 9.9  
Gender  
[units: participants]
     
Female     10     10     20  
Male     48     50     98  
Region of Enrollment  
[units: participants]
     
United States     58     60     118  



  Outcome Measures
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1.  Primary:   Systolic and Diastolic Blood Pressure (SBP, DBP)   [ Time Frame: 24 months ]

2.  Primary:   Total Cholesterol   [ Time Frame: 24 months ]

3.  Primary:   Physical Health-related Quality of Life Score   [ Time Frame: 24 months ]

4.  Secondary:   Manic Symptoms   [ Time Frame: 24 months ]

5.  Secondary:   Depressive Symptom Score   [ Time Frame: 24 months ]

6.  Secondary:   Disability Based on WHO-DAS Score   [ Time Frame: 24 months ]

7.  Secondary:   Body Mass Index (BMI)   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Amy M. Kilbourne, PhD, MPH
Organization: Department of Veterans Affairs
phone: 734-845-3502
e-mail: Amy.Kilbourne@va.gov


No publications provided by Department of Veterans Affairs

Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00499096     History of Changes
Other Study ID Numbers: MHBA-018-06F
Study First Received: July 9, 2007
Results First Received: October 17, 2014
Last Updated: November 12, 2014
Health Authority: United States: Federal Government