Self-Management Addressing Heart Disease Risk Trial

Bipolar Disorder Clinical Trial

— SMAHRT  

Official title:

Cardiovascular Risk Factors in Veterans With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00499096
• Other study ID #: MHBA-018-06F
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2007
• Last updated: November 12, 2014
• Start date: May 2008
• Est. completion date: November 2012

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to learn whether or not people with bipolar disorder can reduce their risk of heart disease and related conditions by having a Care Manager provide self management and care management.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: November 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of bipolar disorder (I, II, not otherwise specified, or schizoaffective-bipolar subtype)

• 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:

• Have unresolved substance intoxication or withdrawal, such as appearing to be intoxicated (e.g., incoherent, slurred speech), or experiencing withdrawal symptoms from substance abuse at the time of enrollment.

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Bipolar Disorder
• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and Diastolic Blood Pressure (SBP, DBP)	24-month systolic and diastolic blood pressure (mm/Hg): lower is better	24 months	No
Primary	Total Cholesterol	Total cholesterol in mg/dl- lower is better	24 months	No
Primary	Physical Health-related Quality of Life Score	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	24 months	No
Secondary	Manic Symptoms	Manic symptoms based on the Internal State Scale (range is 0-500; higher score indicates more severe symptoms)	24 months	No
Secondary	Depressive Symptom Score	Depressive symptoms based on the Internal State Scale (Range: 0-200, higher score = more severe symptoms)	24 months	No
Secondary	Disability Based on WHO-DAS Score	Disability based on the WHO Disability Assessment Scale (WHO-DAS); range = 0-24, higher score equals greater disability	24 months	No
Secondary	Body Mass Index (BMI)	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	24 months	No