Collaborative Care Model on Type 2 Diabetic Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Behavioral: collaborative care

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.

• Study Type: Interventional
• Enrollment (Actual): 255
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Chua Chu Kang Polyclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team.
EXPERIMENTAL: 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.	Behavioral: collaborative care; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: Wei Yan Tan, National Healthcare Group Pharmacy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2018
• Primary Completion (ACTUAL): March 14, 2020
• Study Completion (ACTUAL): May 2, 2020

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (ACTUAL): June 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2017/01191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No