Design and rationale of a randomized controlled trial to reduce cardiovascular disease risk for patients with bipolar disorder

VA Ann Arbor Center for Clinical Management Research, Ann Arbor, MI 48105, USA.
Contemporary clinical trials (Impact Factor: 1.94). 02/2012; 33(4):666-78. DOI: 10.1016/j.cct.2012.02.010
Source: PubMed


Persons with bipolar disorder (BD) experience a disproportionate burden of medical comorbidity, notably cardiovascular disease (CVD), contributing to decreased function and premature mortality. We describe the design, rationale, and baseline findings for the Self-Management Addressing Heart Risk Trial (SMAHRT), a randomized controlled effectiveness trial of an intervention (Life Goals Collaborative Care; LGCC) designed to reduce CVD risk factors and improve physical and mental health outcomes in patients with BD.
Patients with BD and at least one CVD risk factor were recruited from a VA healthcare system and randomized to either LGCC or usual care (UC). LGCC participants attended four weekly, group-based self-management sessions followed by monthly individual contacts supportive of health behavior change and ongoing medical care management. In contrast, UC participants received monthly wellness newsletters. Physiological and questionnaire assessments measured changes in CVD outcomes and quality of life (QOL) over 24 months.
Out of the 180 eligible patients, 134 patients were enrolled (74%) and 118 started the study protocols. At baseline (mean age=54, 17% female, 5% African American) participants had a high burden of clinical risk with nearly 70% reporting at least three CVD risk factors including, smoking (41%) and physical inactivity (57%). Mean mental and physical HRQOL scores were 1.5 SD below SF-12 population averages.
SMAHRT participants experienced substantial CVD morbidity and risk factors, poor symptom control, and decreased QOL. LGCC is the first integrated intervention for BD designed to mitigate suboptimal health outcomes by combining behavioral medicine and care management strategies.

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    • "Using VA electronic medical records, the study data analyst and outcomes assessor would first use the VA electronic medical record system to identify all potentially eligible patients based on the following inclusion criteria: 1. Age 18 years or older with a diagnosis of serious mental illness in the medical record based on the presence of at least one inpatient or outpatient ICD-9-CM [17] diagnosis of schizophrenia, bipolar disorder, or major depressive disorder within the past year from the study recruitment start date (February 15, 2010). These SMI ICD-9 CM diagnoses were chosen because they were considered the most chronic and debilitating mental health diagnoses that are primarily seen in VA specialty mental health clinics [18]. 2. Having at least one of the following risk factors for CVD (cardiovascular disease) recorded in the medical record: a. Body mass index (BMI) N 28 or waist circumference of N 35 (women) or N 40 (men) inches OR. b. "
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    ABSTRACT: Background Persons with serious mental illnesses (SMI) are more likely to die earlier than the general population, primarily due to increased medical burden, particularly from cardiovascular disease (CVD). Life Goals Collaborative Care (LG-CC) is designed to improve health outcomes in SMI through self-management, care management, and provider support. This single-blind randomized controlled effectiveness study will determine whether patients with SMI receiving LG-CC compared to usual care (UC) experience improved physical health in 12 months. Methods Patients diagnosed with SMI and at least one CVD risk factor receiving care at a VA mental health clinic were randomized to LG-CC or UC. LG-CC included five self-management sessions covering mental health symptom management reinforced through health behavior change; care coordination and health monitoring via a registry, and provider feedback. The primary outcome is change in physical health-related quality of life score (VR-12) from baseline to 12 months. Secondary outcomes include changes in mental health-related quality of life, CVD risk factors (blood pressure, BMI), and physical activity from baseline to 12 months later. Results Out of 304 enrolled, 139 were randomized to LG-CC and 145 to UC. Among patients completing baseline assessments (N = 284); the mean age was 55.2 (SD = 10.9; range 28–75 years), 15.6% were women, the majority (62%) were diagnosed with depression, and the majority (63%) were diagnosed with hypertension or were overweight (BMI mean ± SD = 33.3 ± 6.3). Baseline VR-12 physical health component score was below population norms (50.0 ± SD = 10) at 33.4 ± 11.0. Conclusions Findings from this trial may inform initiatives to improve physical health for SMI patient populations.
    Contemporary Clinical Trials 09/2014; 39(1). DOI:10.1016/j.cct.2014.07.007 · 1.94 Impact Factor
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    ABSTRACT: There is growing realization that persons with bipolar disorder may exclusively be seen in primary (general medical) care settings, notably because of limited access to mental health care and stigma in seeking mental health treatment. At least two clinical practice guidelines for bipolar disorder recommend collaborative chronic care models (CCMs) to help integrate mental health care to better manage this illness. CCMs, which include provider guideline support, self-management support, care management, and measurement-based care, are well-established in primary care settings, and may help primary care practitioners manage bipolar disorder. However, further research is required to adapt CCMs to support complexities in diagnosing persons with bipolar disorder, and integrate decision-making processes regarding medication safety and tolerability in primary care. Additional implementation studies are also needed to adapt CCMs for persons with bipolar disorder in primary care, especially those seen in smaller practices with limited infrastructure and access to mental health care.
    Current Psychiatry Reports 09/2012; 14(6). DOI:10.1007/s11920-012-0325-4 · 3.24 Impact Factor
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    ABSTRACT: We examined the association between mood symptoms and 10-year CVD risk estimated by Framingham risk score in a cohort of patients with bipolar disorder. Veterans with bipolar disorder and CVD risk factors (N=118) were recruited from outpatient VA clinics. CVD risk factor data were collected from electronic medical records and patient surveys, and used to calculate patient Framingham Scores. The relationship between mood symptoms (depressive, manic) and Framingham scores was examined, as was the relationship between mental health symptoms and individual CVD risk factors (lipids, blood pressure, weight, smoking, and fasting glucose). Mean sample age was 53 years (SD=9.9), 17% were female, and 5% were African-American. Almost 70% were obese (BMI≥30), 84% had hyperlipidemia, 70% were hypertensive, and 25% had diabetes. Nineteen percent had a Framingham score of >20%, indicative of elevated 10-year risk of developing CVD. After adjusting for age, gender, diabetes diagnosis, smoking status, and mood symptoms, patients with clinically significant depressive symptoms had a 6-fold increased odds of having a Framingham score of >20% (OR=6.1, p=0.03) while clinically significant manic symptoms were not associated with the Framingham score (OR=0.6, p=0.36). Depressive symptoms were also associated with elevated BMI, fasting glucose, and blood pressure. Single-site study reliant on cross-sectional and self-reported mood measures. After controlling for physiologic correlates, depressive symptoms were associated with greater relative 10-year risk for CVD mortality among patients with bipolar disorder. Interventions that address self-management of depressive symptoms may help persons with bipolar disorder decrease CVD risk.
    Journal of Affective Disorders 02/2012; 138(3):405-8. DOI:10.1016/j.jad.2012.01.005 · 3.38 Impact Factor
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