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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
255
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.nurses and dietitians as well as a pharmacist.
Chua Chu Kang Polyclinic
Singapore, Singapore
Change from baseline Body mass index (BMI) at 6-month
Change of BMI in kg/m\^2
Time frame: baseline and 6-month
Change from baseline Glycated Haemoglobin (HbA1c) at 6-month
Change of HbA1c in %
Time frame: baseline and 6-month
Changes from baseline Systolic Blood Pressure (SBP) at 6-month
Change of SBP in mmHg
Time frame: baseline and 6-month
Change from baseline Low-density lipoprotein (LDL) at 6-month
Change of LDL in mg/dL
Time frame: baseline and 6-month
Change from baseline High-density lipoprotein (HDL) at 6-month
Change of HDL in mg/dL
Time frame: baseline and 6-month
Change from baseline Total cholesterol (TC) at 6-month
Change of TC in mg/dL
Time frame: baseline and 6-month
Change from baseline Glycerides (TG) at 6-month
Changes of TG in mg/dL
Time frame: baseline and 6-month
Incidence of hypoglycaemia
Incidence of hypoglycaemia
Time frame: 6-month
Change from baseline Body mass index (BMI) at 12 months
Change BMI in kg/m\^2
Time frame: 12-month
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Change from baseline Glycated Haemoglobin (HbA1c) at 12-month
Changes of HbA1c in %
Time frame: 12-month
Change from baseline Systolic Blood Pressure (SBP) at 12-month
Change of SBP in mmHg
Time frame: 12-month
Change from baseline Low-density lipoprotein (LDL) at 12-month
Changes of LDL in mg/dL
Time frame: 12-month
Change from baseline High-density lipoprotein (HDL) at 12-month
Changes of HDL in mg/dL
Time frame: 12-month
Change from baseline Total cholesterol (TC) at 12-month
Changes of TC in mg/dL
Time frame: 12-month
Change from baseline Glycerides (TG) at 12-month
Changes of TG in mg/dL
Time frame: 12-month
Incidence of hypoglycaemia
Incidence of hypoglycaemia
Time frame: 12-month
The 5-level EQ-5D version (5Q-5D-5L)
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
Time frame: baseline
The 5-level EQ-5D version (5Q-5D-5L)
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
Time frame: 6-month
The 5-level EQ-5D version (5Q-5D-5L)
5Q-5D-5L is a questionnaire containing 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) with 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) for the patients to indicate their health stage.
Time frame: 12-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Time frame: baseline
Audit of Diabetes Dependent Quality of Life (ADDQoL)
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Time frame: 6-month
Audit of Diabetes Dependent Quality of Life (ADDQoL)
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Time frame: 12-month
The Problem Area in Diabetes (PAID)
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
Time frame: baseline
The Problem Area in Diabetes (PAID)
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
Time frame: 6-month
The Problem Area in Diabetes (PAID)
The PAID is a valid and reliable 20-item questionnaire measuring diabetes-related distress with a five-point Likert scale that ranges from 0 (not a problem) to 4 (serious problem).
Time frame: 12-month
Summary of Diabetes Self-Care Activities (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
Time frame: baseline
Summary of Diabetes Self-Care Activities (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
Time frame: 6-month
Summary of Diabetes Self-Care Activities (SDSCA)
The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes 14 items assessing the following aspects of the diabetes regimen: general dies, specific diet, exercise, blood-glucose testing, foot care, and smoking.
Time frame: 12-month
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Time frame: baseline
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Time frame: 6-month
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Time frame: 12-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
The WPAI-GH is a 6-item questionnaire measuring absenteeism, presenteeism, overall work productivity loss, and daily activity impairment with a 10-point scale that range from 0 (no effect on daily activities) to 10 (serious effect on daily activities).
Time frame: 6-month
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
The WPAI-GH is a 6-item questionnaire measuring absenteeism, presenteeism, overall work productivity loss, and daily activity impairment with a 10-point scale that range from 0 (no effect on daily activities) to 10 (serious effect on daily activities).
Time frame: 12-month