Clinical trial NCT03553862: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 255
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change from baseline Body mass index (BMI) at 6-month
timeFrame: baseline and 6-month
measure: Change from baseline Glycated Haemoglobin (HbA1c) at 6-month
timeFrame: baseline and 6-month
measure: Changes from baseline Systolic Blood Pressure (SBP) at 6-month
timeFrame: baseline and 6-month
measure: Change from baseline Low-density lipoprotein (LDL) at 6-month
timeFrame: baseline and 6-month
measure: Change from baseline High-density lipoprotein (HDL) at 6-month
timeFrame: baseline and 6-month
measure: Change from baseline Total cholesterol (TC) at 6-month
timeFrame: baseline and 6-month
measure: Change from baseline Glycerides (TG) at 6-month
timeFrame: baseline and 6-month
measure: Incidence of hypoglycaemia
timeFrame: 6-month
measure: Change from baseline Body mass index (BMI) at 12 months
timeFrame: 12-month
measure: Change from baseline Glycated Haemoglobin (HbA1c) at 12-month
timeFrame: 12-month
measure: Change from baseline Systolic Blood Pressure (SBP) at 12-month
timeFrame: 12-month
measure: Change from baseline Low-density lipoprotein (LDL) at 12-month
timeFrame: 12-month
measure: Change from baseline High-density lipoprotein (HDL) at 12-month
timeFrame: 12-month
measure: Change from baseline Total cholesterol (TC) at 12-month
timeFrame: 12-month
measure: Change from baseline Glycerides (TG) at 12-month
timeFrame: 12-month
measure: Incidence of hypoglycaemia
timeFrame: 12-month
Secondary outcomes:
measure: The 5-level EQ-5D version (5Q-5D-5L)
timeFrame: baseline
measure: The 5-level EQ-5D version (5Q-5D-5L)
timeFrame: 6-month
measure: The 5-level EQ-5D version (5Q-5D-5L)
timeFrame: 12-month
measure: Audit of Diabetes Dependent Quality of Life (ADDQoL)
timeFrame: baseline
measure: Audit of Diabetes Dependent Quality of Life (ADDQoL)
timeFrame: 6-month
measure: Audit of Diabetes Dependent Quality of Life (ADDQoL)
timeFrame: 12-month
measure: The Problem Area in Diabetes (PAID)
timeFrame: baseline
measure: The Problem Area in Diabetes (PAID)
timeFrame: 6-month
measure: The Problem Area in Diabetes (PAID)
timeFrame: 12-month
measure: Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: baseline
measure: Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: 6-month
measure: Summary of Diabetes Self-Care Activities (SDSCA)
timeFrame: 12-month
measure: Self-report Hypoglycaemia Question
timeFrame: baseline
measure: Self-report Hypoglycaemia Question
timeFrame: 6-month
measure: Self-report Hypoglycaemia Question
timeFrame: 12-month
measure: Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
timeFrame: 6-month
measure: Work Productivity and Activity Impairment questionnaire, General Health version (WPAI-GH)
timeFrame: 12-month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Chua Chu Kang Polyclinic
Study officials:
affiliation: National Healthcare Group Pharmacy
name: Wei Yan Tan
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.