Schizophrenia Clinical Trial
Official title:
Life Goals Behavioral Change to Improve Outcomes for Veterans With SMI
Verified date | June 2017 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Persons with serious mental illness are at increased risk of cardiovascular disease. The goals of this study are to test a treatment, Life Goals Collaborative Care to help promote health behavior change and to get feedback from patients and providers on what is needed to help better coordinate and physical and mental health care of these patients.
Status | Completed |
Enrollment | 55 |
Est. completion date | March 6, 2015 |
Est. primary completion date | August 13, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of serious mental illness (schizophrenia, bipolar disorder, other psychosis, major depressive disorder, or other recurrent depression or affective disorder) - Have at least one of the following risk factors for CVD (cardiovascular disease): Body mass index (BMI) >28 or waist circumference of >35 (women) or >40 (men) inches OR Self-reported diagnosis of hypertension ("high blood pressure"), dyslipidemia ("high cholesterol") or diabetes or high blood sugar OR Documentation in the medical record of a diagnosis of or treatment for hypertension (defined as documented diagnosis or blood pressure of >140/90 on 2 occasions or prescription for an antihypertensive medication), dyslipidemia (documented diagnosis or LDL>160 or prescription for a lipid-lowering medication) or diabetes mellitus (documented diagnosis or HbA1C >7% or current prescription for oral hypoglycemic therapy) 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 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 sessions due to substantial functional limitations). - Active suicidal ideation at time of enrollment (focused interventions are more appropriate for this group) |
Country | Name | City | State |
---|---|---|---|
United States | VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Goodrich DE, Lai Z, Lasky E, Burghardt AR, Kilbourne AM. Access to weight loss counseling services among patients with bipolar disorder. J Affect Disord. 2010 Oct;126(1-2):75-9. doi: 10.1016/j.jad.2010.02.138. Epub 2010 Apr 8. — View Citation
Kilbourne AM, Bramlet M, Barbaresso MM, Nord KM, Goodrich DE, Lai Z, Post EP, Almirall D, Verchinina L, Duffy SA, Bauer MS. SMI life goals: description of a randomized trial of a collaborative care model to improve outcomes for persons with serious mental — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall health-related quality of life | 6 months | ||
Secondary | Framingham risk score | 6 months | ||
Secondary | total cholesterol | 6 months | ||
Secondary | systolic blood pressure | 6 months |
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