Self-Management Addressing Heart Disease Risk Trial

Completed · Phase 3

Conditions studied: Bipolar Disorder, Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT00499096

Run by

US Department of Veterans Affairs

People needed

118

Starts

2008-05-01

Expected to finish

2012-11-01

Last updated by the study team

2014-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• VA Ann Arbor Healthcare System — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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