Clinical trial NCT00499096: Self-Management Addressing Heart Disease Risk Trial
Official title: Cardiovascular Risk Factors in Veterans With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Cardiovascular Disease
Keywords: Chronic Illness
Disease management
Health Behaviors
Mood Disorders-Bipolar
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-07-11
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Systolic and Diastolic Blood Pressure (SBP, DBP)
timeFrame: 24 months
measure: Total Cholesterol
timeFrame: 24 months
measure: Physical Health-related Quality of Life Score
timeFrame: 24 months
Secondary outcomes:
measure: Manic Symptoms
timeFrame: 24 months
measure: Depressive Symptom Score
timeFrame: 24 months
measure: Disability Based on WHO-DAS Score
timeFrame: 24 months
measure: Body Mass Index (BMI)
timeFrame: 24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System
name: Amy M. Kilbourne, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.