Self-Management Addressing Heart Disease Risk Trial (SMAHRT)
|ClinicalTrials.gov Identifier: NCT00499096|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : November 20, 2014
Last Update Posted : November 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Cardiovascular Disease||Behavioral: Chronic care model for Bipolar Disorder||Phase 3|
Background: Bipolar disorder is associated with significant personal and societal costs, and represents a substantial burden to the VA. Medical conditions, notably cardiovascular disease (CVD), are substantial contributors to increased morbidity and mortality in patients with bipolar disorder, in part because of behavioral and treatment factors. Despite the existence of effective medications for managing CVD-related risk factors (e.g., hypertension, hyperlipidemia, diabetes, obesity), outcomes for these conditions remain suboptimal among patients with bipolar disorder.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||Cardiovascular Risk Factors in Veterans With Bipolar Disorder|
|Study Start Date :||May 2008|
|Primary Completion Date :||May 2012|
|Study Completion Date :||November 2012|
Experimental: 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
Behavioral: 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.
No Intervention: 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.
- Systolic and Diastolic Blood Pressure (SBP, DBP) [ Time Frame: 24 months ]24-month systolic and diastolic blood pressure (mm/Hg): lower is better
- Total Cholesterol [ Time Frame: 24 months ]Total cholesterol in mg/dl- lower is better
- Physical Health-related Quality of Life Score [ Time Frame: 24 months ]Physical health-related quality of life is based on the Short Form (SF)-12 survey physical health component (PCS) score- which ranges from 0 to 50, with higher scores indicating higher quality of life
- Manic Symptoms [ Time Frame: 24 months ]Manic symptoms based on the Internal State Scale (range is 0-500; higher score indicates more severe symptoms)
- Depressive Symptom Score [ Time Frame: 24 months ]Depressive symptoms based on the Internal State Scale (Range: 0-200, higher score = more severe symptoms)
- Disability Based on WHO-DAS Score [ Time Frame: 24 months ]Disability based on the WHO Disability Assessment Scale (WHO-DAS); range = 0-24, higher score equals greater disability
- Body Mass Index (BMI) [ Time Frame: 24 months ]Body mass index (BMI) is reported in kilograms divided by meters squared (kg/m^2) with a normal (healthy) range of 18-24, in which >=25 is considered overweight, and >=30 is the definition of obesity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499096
|United States, Michigan|
|VA Ann Arbor Healthcare System|
|Ann Arbor, Michigan, United States, 48113|
|Principal Investigator:||Amy M. Kilbourne, PhD MPH||VA Ann Arbor Healthcare System|