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临床试验/NCT02011529
NCT02011529已完成不适用

A Team Approach to Improve the Quality of Diabetes Care for Patients With Schizophrenia

University of Washington1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年11月1日最近更新:
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
35
试验地点
1
主要终点
Hemoglobin A1c

研究概览

简要总结

This proposal aims to demonstrate the feasibility and acceptability of adapting TEAMcare for patients with schizophrenia. The aim of this innovative mental health center-based team intervention is to improve diabetes, cardiovascular and psychiatric outcomes among patients with poorly controlled type 2 diabetes. The study will be conducted in two phases over the 2-year grant period.

Phase 1. Development of the adapted TEAMcare intervention and training of team members.

Phase 2. During year 2, we will implement the intervention on the caseload of 40 outpatients at Harborview Mental Health Services with schizophrenia and poorly controlled type 2 diabetes. The intervention involves the management of subjects' diabetes, hypertension, and hyperlipidemia by a CMHC diabetes team for 6 months (advanced nurse specialist on-site at supervised in weekly meetings by a psychiatrist and a UW Diabetes Center endocrinologist).

The primary aim of this pilot research grant is to evaluate the feasibility of implementing this complex intervention, in order to guide the design of a larger scale efficacy study (R01). Both process and outcome measures will be evaluated at baseline, and at 3- and 6-month follow-up visits for the 40 subjects enrolled in this feasibility trial.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult (18-70 years);
  • •enrolled to receive mental health treatment at Harborview Mental Health Services or Downtown Emergency Services Mental Health center
  • •a diagnosis of type 2 diabetes mellitus or cardiovascular disease
  • •Hemoglobin A1c >8 or BP > 140/90

排除标准

  • •cognitive, hearing, or language impairment that would preclude a subject from providing informed consent;
  • •current suicidality, homicidality, or grave disability that requires psychiatric hospitalization;
  • •current substance abuse or dependence, as defined by SCID.

研究组 & 干预措施

TEAMcare treatment of diabetes

Active Comparator

干预措施: TEAMcare treatment of diabetes (Other)

Treatment as usual

No Intervention

Participants randomized to treatment as usual will receive their usual mental health treatment and primary care treatment

结局指标

主要结局

Hemoglobin A1c

时间窗: 6 months

次要结局

  • LDL cholesterol(6 months)
  • Blood Pressure(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lydia Chwastiak

Associate Professor

University of Washington

研究点 (1)

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