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临床试验/NCT03553862
NCT03553862
已完成
不适用

The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore

National University of Singapore1 个研究点 分布在 1 个国家目标入组 255 人2018年5月11日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Type2 Diabetes
发起方
National University of Singapore
入组人数
255
试验地点
1
主要终点
Change from baseline Body mass index (BMI) at 6-month
状态
已完成
最后更新
5年前

概览

简要总结

The purpose of this study is to determine the effectiveness of the collaborative care model in Singapore in which clinical pharmacists, nurses and dietitians are active participants who collaborate with physicians in caring for patients with Type 2 diabetes mellitus (DM).Since DM is a cardiovascular risk equivalent, co-morbidities such as hypertension (HTN) and dyslipidaemia (DLP) will also be evaluated to assess the holistic care provided for the investigator's patients afflicted with these top chronic diseases in Singapore.

详细描述

Specifically, this study aims to evaluate the effectiveness of an integrated collaborative care model comprising of a healthcare team (physician, clinical pharmacist, nurse, and/or dietitian) compared to the usual or conventional healthcare model (physician-centered care) mainly in the clinical, humanistic and economic outcomes.

注册库
clinicaltrials.gov
开始日期
2018年5月11日
结束日期
2020年5月2日
最后更新
5年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Joyce Lee, PharmD

Principle Investigator

National University of Singapore

入排标准

入选标准

  • Patients aged ≥ 21 years with Type 2 DM (HbA1c \> 7%) and polypharmacy (≥ 5 medications) will be eligible for this study.

排除标准

  • Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.

结局指标

主要结局

Change from baseline Body mass index (BMI) at 6-month

时间窗: baseline and 6-month

Change of BMI in kg/m\^2

Change from baseline Glycated Haemoglobin (HbA1c) at 6-month

时间窗: baseline and 6-month

Change of HbA1c in %

Changes from baseline Systolic Blood Pressure (SBP) at 6-month

时间窗: baseline and 6-month

Change of SBP in mmHg

Change from baseline Low-density lipoprotein (LDL) at 6-month

时间窗: baseline and 6-month

Change of LDL in mg/dL

Change from baseline High-density lipoprotein (HDL) at 6-month

时间窗: baseline and 6-month

Change of HDL in mg/dL

Change from baseline Total cholesterol (TC) at 6-month

时间窗: baseline and 6-month

Change of TC in mg/dL

Change from baseline Glycerides (TG) at 6-month

时间窗: baseline and 6-month

Changes of TG in mg/dL

Incidence of hypoglycaemia

时间窗: 12-month

Incidence of hypoglycaemia

Change from baseline Body mass index (BMI) at 12 months

时间窗: 12-month

Change BMI in kg/m\^2

Change from baseline Glycated Haemoglobin (HbA1c) at 12-month

时间窗: 12-month

Changes of HbA1c in %

Change from baseline Systolic Blood Pressure (SBP) at 12-month

时间窗: 12-month

Change of SBP in mmHg

Change from baseline Low-density lipoprotein (LDL) at 12-month

时间窗: 12-month

Changes of LDL in mg/dL

Change from baseline High-density lipoprotein (HDL) at 12-month

时间窗: 12-month

Changes of HDL in mg/dL

Change from baseline Total cholesterol (TC) at 12-month

时间窗: 12-month

Changes of TC in mg/dL

Change from baseline Glycerides (TG) at 12-month

时间窗: 12-month

Changes of TG in mg/dL

次要结局

  • The 5-level EQ-5D version (5Q-5D-5L)(12-month)
  • Audit of Diabetes Dependent Quality of Life (ADDQoL)(12-month)
  • The Problem Area in Diabetes (PAID)(12-month)
  • Summary of Diabetes Self-Care Activities (SDSCA)(12-month)
  • Self-report Hypoglycaemia Question(12-month)
  • Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)(12-month)

研究点 (1)

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