Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2008-05-31
2012-11-30
Brief Summary
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Detailed Description
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Objectives: The immediate objective of this study is to determine whether a manual-based Chronic Care Model (CCM) intervention compared to usual VA care improves control of intermediate physiological measures that represent risk factors of CVD for veterans with bipolar disorder. We hypothesize that, within 12 months of the intervention initiation, patients receiving the CCM intervention will be more likely to demonstrate improved control of CVD-related risk factors (blood pressure, fasting cholesterol) and report improved physical health-related quality of life.
Methods: This is a prospective, randomized, controlled, single-blind, single-site behavioral intervention trial of adult patients with a diagnosis of bipolar disorder receiving care in the VA Ann Arbor Healthcare System. Up to 300 subjects will be enrolled, of which 150 will be randomized to receive the intervention and 150 will receive usual VA care. All subjects will complete a baseline clinical assessment and then subsequent follow-up assessments at 3, 6, 12, and 24 months. The intervention's three core components will be implemented by a nurse Care Manager and include: 1) self-management behavioral sessions for patients addressing the reduction of CVD risk factors through symptom control and behavior change based on Social Cognitive Theory, 2) care management to promote patient behavior change and coordinate care, and 3) implementation of practice guidelines for providers on management of CVD risk factors in patients with bipolar disorder. Medical and psychiatric care, including medications, will continue to be provided by the patient's usual providers. Usual VA care will be enhanced and consist of guideline implementation and general patient education (attention control), but will not include self-management sessions or Care Manager contacts. Primary clinical outcomes include changes in cholesterol, and health-related quality of life (SF-12 physical health summary score). Linear regression models will be used to determine the effect of the intervention on each outcome. Mediators of treatment effect including symptoms and health behaviors will also be assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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. This is the chronic care model for bipolar disorder
Chronic care model for Bipolar Disorder
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.
No interventions assigned to this group
Interventions
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Chronic care model for Bipolar Disorder
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.
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis or be at risk for arteriosclerotic cardiovascular disease (ASCVD).
We define this as a patient having a current diagnosis of or receiving treatment for at least one of the following medical conditions:
* hyperlipidemia or dyslipidemia (documented diagnosis or low-density lipoprotein \>=160, or receiving statin or other treatment)
* hypertension (documented diagnosis or blood pressure of \>=140/90 on 2 occasions)
* diabetes mellitus (documented diagnosis or HbA1C \>=7%, or receiving treatment)
* obesity (documented diagnosis or BMI \>30), based on medical record review of current problems
* current ASCVD diagnosis
Exclusion Criteria
* Are 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). These patients may be receiving similar services to those offered in the intervention.
* Are unwilling or unable to provide informed consent or comply with study requirements at the time of enrollment (e.g., unable to complete forms or attend scheduled sessions due to serious illness or substantial functional limitations).
18 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Amy M. Kilbourne, PhD MPH
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System
Locations
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VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Countries
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References
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Kilbourne AM, Goodrich DE, Lai Z, Post EP, Schumacher K, Nord KM, Bramlet M, Chermack S, Bialy D, Bauer MS. Randomized controlled trial to assess reduction of cardiovascular disease risk in patients with bipolar disorder: the Self-Management Addressing Heart Risk Trial (SMAHRT). J Clin Psychiatry. 2013 Jul;74(7):e655-62. doi: 10.4088/JCP.12m08082.
Other Identifiers
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MHBA-018-06F
Identifier Type: -
Identifier Source: org_study_id