Collaborative Care Model on Type 2 Diabetic Patients

NCT03553862 | Completed

• 1 other identifier: 2017/01191
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (17)

• The 5-level EQ-5D version (5Q-5D-5L)

  baseline

• The 5-level EQ-5D version (5Q-5D-5L)

  6-month

• The 5-level EQ-5D version (5Q-5D-5L)

  12-month

• Audit of Diabetes Dependent Quality of Life (ADDQoL)

  baseline

• Audit of Diabetes Dependent Quality of Life (ADDQoL)

  6-month

Study Arms (2)

Control

NO INTERVENTION

Patients randomly assigned to the control arm will receive the usual or conventional care not interfered by the study team.

Intervention

EXPERIMENTAL

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

Interventions

collaborative care BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 21 years with Type 2 DM (HbA1c \> 7%) and polypharmacy (≥ 5 medications) will be eligible for this study.

You may not qualify if:

• Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

Chua Chu Kang Polyclinic

Singapore, Singapore

Location

Related Publications (4)

• 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.

  PMID: 28449205 BACKGROUND

• 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.

  PMID: 22971205 BACKGROUND

• 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.

  PMID: 17057049 BACKGROUND

• 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.

  PMID: 15583361 BACKGROUND

Study Officials

• Wei Yan Tan

  National Healthcare Group Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 12, 2018
• Study Start: May 11, 2018
• Primary Completion: March 14, 2020
• Study Completion: May 2, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)