Collaborative Care Model on Type 2 Diabetic Patients
Primary Purpose
Type2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
collaborative care
Sponsored by

About this trial
This is an interventional health services research trial for Type2 Diabetes
Eligibility Criteria
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.
Sites / Locations
- Chua Chu Kang Polyclinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team.
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.
Outcomes
Primary Outcome Measures
Change from baseline Body mass index (BMI) at 6-month
Change of BMI in kg/m^2
Change from baseline Glycated Haemoglobin (HbA1c) at 6-month
Change of HbA1c in %
Changes from baseline Systolic Blood Pressure (SBP) at 6-month
Change of SBP in mmHg
Change from baseline Low-density lipoprotein (LDL) at 6-month
Change of LDL in mg/dL
Change from baseline High-density lipoprotein (HDL) at 6-month
Change of HDL in mg/dL
Change from baseline Total cholesterol (TC) at 6-month
Change of TC in mg/dL
Change from baseline Glycerides (TG) at 6-month
Changes of TG in mg/dL
Incidence of hypoglycaemia
Incidence of hypoglycaemia
Change from baseline Body mass index (BMI) at 12 months
Change BMI in kg/m^2
Change from baseline Glycated Haemoglobin (HbA1c) at 12-month
Changes of HbA1c in %
Change from baseline Systolic Blood Pressure (SBP) at 12-month
Change of SBP in mmHg
Change from baseline Low-density lipoprotein (LDL) at 12-month
Changes of LDL in mg/dL
Change from baseline High-density lipoprotein (HDL) at 12-month
Changes of HDL in mg/dL
Change from baseline Total cholesterol (TC) at 12-month
Changes of TC in mg/dL
Change from baseline Glycerides (TG) at 12-month
Changes of TG in mg/dL
Incidence of hypoglycaemia
Incidence of hypoglycaemia
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Self-report Hypoglycaemia Question
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
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).
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).
Full Information
NCT ID
NCT03553862
First Posted
May 9, 2018
Last Updated
March 2, 2021
Sponsor
National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT03553862
Brief Title
Collaborative Care Model on Type 2 Diabetic Patients
Official Title
The Impact of Collaborative Care Model in the Management of Primary Care Patients With Type 2 Diabetes Mellitus in Singapore
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2018 (Actual)
Primary Completion Date
March 14, 2020 (Actual)
Study Completion Date
May 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
collaborative care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Body mass index (BMI) at 6-month
Description
Change of BMI in kg/m^2
Time Frame
baseline and 6-month
Title
Change from baseline Glycated Haemoglobin (HbA1c) at 6-month
Description
Change of HbA1c in %
Time Frame
baseline and 6-month
Title
Changes from baseline Systolic Blood Pressure (SBP) at 6-month
Description
Change of SBP in mmHg
Time Frame
baseline and 6-month
Title
Change from baseline Low-density lipoprotein (LDL) at 6-month
Description
Change of LDL in mg/dL
Time Frame
baseline and 6-month
Title
Change from baseline High-density lipoprotein (HDL) at 6-month
Description
Change of HDL in mg/dL
Time Frame
baseline and 6-month
Title
Change from baseline Total cholesterol (TC) at 6-month
Description
Change of TC in mg/dL
Time Frame
baseline and 6-month
Title
Change from baseline Glycerides (TG) at 6-month
Description
Changes of TG in mg/dL
Time Frame
baseline and 6-month
Title
Incidence of hypoglycaemia
Description
Incidence of hypoglycaemia
Time Frame
6-month
Title
Change from baseline Body mass index (BMI) at 12 months
Description
Change BMI in kg/m^2
Time Frame
12-month
Title
Change from baseline Glycated Haemoglobin (HbA1c) at 12-month
Description
Changes of HbA1c in %
Time Frame
12-month
Title
Change from baseline Systolic Blood Pressure (SBP) at 12-month
Description
Change of SBP in mmHg
Time Frame
12-month
Title
Change from baseline Low-density lipoprotein (LDL) at 12-month
Description
Changes of LDL in mg/dL
Time Frame
12-month
Title
Change from baseline High-density lipoprotein (HDL) at 12-month
Description
Changes of HDL in mg/dL
Time Frame
12-month
Title
Change from baseline Total cholesterol (TC) at 12-month
Description
Changes of TC in mg/dL
Time Frame
12-month
Title
Change from baseline Glycerides (TG) at 12-month
Description
Changes of TG in mg/dL
Time Frame
12-month
Title
Incidence of hypoglycaemia
Description
Incidence of hypoglycaemia
Time Frame
12-month
Secondary Outcome Measure Information:
Title
The 5-level EQ-5D version (5Q-5D-5L)
Description
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
Title
The 5-level EQ-5D version (5Q-5D-5L)
Description
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
Title
The 5-level EQ-5D version (5Q-5D-5L)
Description
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
Title
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Description
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Time Frame
baseline
Title
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Description
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Time Frame
6-month
Title
Audit of Diabetes Dependent Quality of Life (ADDQoL)
Description
The ADDQoL is a 19-item questionnaire measuring the effects of diabetes and its treatment on individuals' quality of life.
Time Frame
12-month
Title
The Problem Area in Diabetes (PAID)
Description
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
Title
The Problem Area in Diabetes (PAID)
Description
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
Title
The Problem Area in Diabetes (PAID)
Description
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
Title
Summary of Diabetes Self-Care Activities (SDSCA)
Description
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
Title
Summary of Diabetes Self-Care Activities (SDSCA)
Description
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
Title
Summary of Diabetes Self-Care Activities (SDSCA)
Description
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
Title
Self-report Hypoglycaemia Question
Description
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Time Frame
baseline
Title
Self-report Hypoglycaemia Question
Description
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Time Frame
6-month
Title
Self-report Hypoglycaemia Question
Description
It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.
Time Frame
12-month
Title
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
Description
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
Title
Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Yan Tan
Organizational Affiliation
National Healthcare Group Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chua Chu Kang Polyclinic
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28449205
Citation
Siaw MYL, Ko Y, Malone DC, Tsou KYK, Lew YJ, Foo D, Tan E, Chan SC, Chia A, Sinaram SS, Goh KC, Lee JY. Impact of pharmacist-involved collaborative care on the clinical, humanistic and cost outcomes of high-risk patients with type 2 diabetes (IMPACT): a randomized controlled trial. J Clin Pharm Ther. 2017 Aug;42(4):475-482. doi: 10.1111/jcpt.12536. Epub 2017 Apr 27.
Results Reference
background
PubMed Identifier
22971205
Citation
Jarab AS, Alqudah SG, Mukattash TL, Shattat G, Al-Qirim T. Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan. J Manag Care Pharm. 2012 Sep;18(7):516-26. doi: 10.18553/jmcp.2012.18.7.516.
Results Reference
background
PubMed Identifier
17057049
Citation
Scott DM, Boyd ST, Stephan M, Augustine SC, Reardon TP. Outcomes of pharmacist-managed diabetes care services in a community health center. Am J Health Syst Pharm. 2006 Nov 1;63(21):2116-22. doi: 10.2146/ajhp060040.
Results Reference
background
PubMed Identifier
15583361
Citation
Taylor KI, Oberle KM, Crutcher RA, Norton PG. Promoting health in type 2 diabetes: nurse-physician collaboration in primary care. Biol Res Nurs. 2005 Jan;6(3):207-15. doi: 10.1177/1099800404272223.
Results Reference
background
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Collaborative Care Model on Type 2 Diabetic Patients
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