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临床试验/NCT01115114
NCT01115114已完成不适用

Treatment of Metabolic Syndrome in a Community Mental Health Center

The University of Texas Health Science Center at San Antonio4 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2009年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
4
主要终点
Utilization of Care

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Treatment as Usual (TAU)

Placebo Comparator

Study Intervention 1 Treatment as usual (TAU) will be psychiatry follow-up at local Community Mental Health Clinic at least every 3 months.

干预措施: TAU (Behavioral)

结局指标

主要结局

Utilization of Care

时间窗: 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.

次要结局

  • Metabolic Indicators(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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