Collaborative Care Model on Type 2 Diabetic Patients

Type2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553862
• Other study ID #: 2017/01191
• Status: Completed
• Phase: N/A
• Start date: May 11, 2018
• Est. completion date: May 2, 2020

Study information

• Verified date: March 2021
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: May 2, 2020
• Est. primary completion date: March 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Singapore	Chua Chu Kang Polyclinic	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Body mass index (BMI) at 6-month	Change of BMI in kg/m^2	baseline and 6-month
Primary	Change from baseline Glycated Haemoglobin (HbA1c) at 6-month	Change of HbA1c in %	baseline and 6-month
Primary	Changes from baseline Systolic Blood Pressure (SBP) at 6-month	Change of SBP in mmHg	baseline and 6-month
Primary	Change from baseline Low-density lipoprotein (LDL) at 6-month	Change of LDL in mg/dL	baseline and 6-month
Primary	Change from baseline High-density lipoprotein (HDL) at 6-month	Change of HDL in mg/dL	baseline and 6-month
Primary	Change from baseline Total cholesterol (TC) at 6-month	Change of TC in mg/dL	baseline and 6-month
Primary	Change from baseline Glycerides (TG) at 6-month	Changes of TG in mg/dL	baseline and 6-month
Primary	Incidence of hypoglycaemia	Incidence of hypoglycaemia	6-month
Primary	Change from baseline Body mass index (BMI) at 12 months	Change BMI in kg/m^2	12-month
Primary	Change from baseline Glycated Haemoglobin (HbA1c) at 12-month	Changes of HbA1c in %	12-month
Primary	Change from baseline Systolic Blood Pressure (SBP) at 12-month	Change of SBP in mmHg	12-month
Primary	Change from baseline Low-density lipoprotein (LDL) at 12-month	Changes of LDL in mg/dL	12-month
Primary	Change from baseline High-density lipoprotein (HDL) at 12-month	Changes of HDL in mg/dL	12-month
Primary	Change from baseline Total cholesterol (TC) at 12-month	Changes of TC in mg/dL	12-month
Primary	Change from baseline Glycerides (TG) at 12-month	Changes of TG in mg/dL	12-month
Primary	Incidence of hypoglycaemia	Incidence of hypoglycaemia	12-month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Self-report Hypoglycaemia Question	It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.	baseline
Secondary	Self-report Hypoglycaemia Question	It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.	6-month
Secondary	Self-report Hypoglycaemia Question	It is 5-item questionnaire for the patients with diabetes to self-assess their symptoms of hypoglycaemia.	12-month
Secondary	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
Secondary	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