Skip to main content
Clinical Trials/NCT01115114
NCT01115114
Completed
Not Applicable

Treatment of Metabolic Syndrome in a Community Mental Health Center

The University of Texas Health Science Center at San Antonio2 sites in 1 country130 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Serious Mental Illness
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
130
Locations
2
Primary Endpoint
Utilization of Care
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to learn if patients being treated with second generation antipsychotics and with clinically meaningful elevations/levels in any metabolic syndrome elements will have better access to medical treatment more quickly if they are randomized to one of the following conditions: 1) a primary care provider located in the community mental health center where mental health treatment is provided (IMBED), 2) a medical care manager to help coordinate treatment with an outside primary care provider (Liaison) or 3) the standard practice of advising the patient to see a primary care doctor (Treatment as Usual).

Detailed Description

Individuals will be identified for participation based upon baseline laboratory values obtained at the local Community Mental Health Clinic (CMHC) as part of the standard monitoring procedures for individuals on Second Generation Antipsychotics (SGAs). Following randomization, a research assistant will be assigned to obtain information on primary care provider visits, medications and lab tests conducted outside of the CMHC using a signed release for from the patient. Variables collected include: date and time of all physician or practitioner visits, type of practitioner, all medication prescriptions, and all laboratory values and vital signs related to metabolic syndrome parameters. Data will be put into an access data base for analysis. Data from private pharmacies will be obtained using a separate signed consent form.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
January 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Males and Females 18 years and older
  • Active CMHC consumers
  • Currently taking an atypical antipsychotic
  • Identified as having clinically meaningful elevations/levels in metabolic indicators; i.e. fasting blood glucose (≥ 110), HDL ≤ 40mg/dl for males or ≤ 50mg/dl for females, blood pressure (≥ 130/85)
  • Able to give informed consent
  • Recipient of private or publicly-financed health insurance that includes medication coverage

Exclusion Criteria

  • Legally declared mentally incompetent (guardians will not be approached about study)

Outcomes

Primary Outcomes

Utilization of Care

Time Frame: 9 months

We will compare the efficacy of IMBED, Liaison and Treatment as Usual for improving utilization of care. The primary outcome variables are time to contact with primary care practitioner, number of primary care visits, receiving appropriate medications, receiving appropriate labs, and receiving dietary and life style counseling.

Secondary Outcomes

  • Metabolic Indicators(9 months)

Study Sites (2)

Loading locations...

Similar Trials