The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Change from baseline Body mass index (BMI) at 6-month
研究概览
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.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
Control
Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team.
Intervention
The intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist.
干预措施: collaborative care (Behavioral)
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
Incidence of hypoglycaemia
时间窗: 6-month
Incidence of hypoglycaemia
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)
- The 5-level EQ-5D version (5Q-5D-5L)(baseline)
- The 5-level EQ-5D version (5Q-5D-5L)(6-month)
- Audit of Diabetes Dependent Quality of Life (ADDQoL)(baseline)
- Audit of Diabetes Dependent Quality of Life (ADDQoL)(6-month)
- The Problem Area in Diabetes (PAID)(baseline)
- The Problem Area in Diabetes (PAID)(6-month)
- Summary of Diabetes Self-Care Activities (SDSCA)(baseline)
- Summary of Diabetes Self-Care Activities (SDSCA)(6-month)
- Self-report Hypoglycaemia Question(baseline)
- Self-report Hypoglycaemia Question(6-month)
- Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)(6-month)
研究者
Joyce Lee, PharmD
Principle Investigator
National University of Singapore