Collaborative Care Model on Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: collaborative care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 21 years with Type 2 DM (HbA1c > 7%) and polypharmacy (≥ 5 medications) will be eligible for this study. Exclusion Criteria: Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team. | |
| Experimental: Intervention<br>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. | Behavioral: collaborative care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Body mass index (BMI) at 6-month | Change of BMI in kg/m^2 | baseline and 6-month | 
| Change from baseline Glycated Haemoglobin (HbA1c) at 6-month | Change of HbA1c in % | baseline and 6-month | 
| Changes from baseline Systolic Blood Pressure (SBP) at 6-month | Change of SBP in mmHg | baseline and 6-month | 
| Change from baseline Low-density lipoprotein (LDL) at 6-month | Change of LDL in mg/dL | baseline and 6-month | 
| Change from baseline High-density lipoprotein (HDL) at 6-month | Change of HDL in mg/dL | baseline and 6-month | 
| Change from baseline Total cholesterol (TC) at 6-month | Change of TC in mg/dL | baseline and 6-month | 
| Change from baseline Glycerides (TG) at 6-month | Changes of TG in mg/dL | baseline and 6-month | 
| Incidence of hypoglycaemia | Incidence of hypoglycaemia | 6-month | 
| Change from baseline Body mass index (BMI) at 12 months | Change BMI in kg/m^2 | 12-month | 
| Change from baseline Glycated Haemoglobin (HbA1c) at 12-month | Changes of HbA1c in % | 12-month | 
| Change from baseline Systolic Blood Pressure (SBP) at 12-month | Change of SBP in mmHg | 12-month | 
| Change from baseline Low-density lipoprotein (LDL) at 12-month | Changes of LDL in mg/dL | 12-month | 
| Change from baseline High-density lipoprotein (HDL) at 12-month | Changes of HDL in mg/dL | 12-month | 
| Change from baseline Total cholesterol (TC) at 12-month | Changes of TC in mg/dL | 12-month | 
| Change from baseline Glycerides (TG) at 12-month | Changes of TG in mg/dL | 12-month | 
| Incidence of hypoglycaemia | Incidence of hypoglycaemia | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 12-month | 
| Self-report Hypoglycaemia Question | It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia. | baseline | 
| Self-report Hypoglycaemia Question | It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia. | 6-month | 
| Self-report Hypoglycaemia Question | It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia. | 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). | 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). | 12-month |