Collaborative Care Model on Type 2 Diabetic Patients
- Conditions
- Type2 Diabetes
- Interventions
- Behavioral: collaborative care
- Registration Number
- NCT03553862
- Lead Sponsor
- National University of Singapore
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- Patients aged ≥ 21 years with Type 2 DM (HbA1c > 7%) and polypharmacy (≥ 5 medications) will be eligible for this study.
- Patients with Type 1 DM or who are unable to communicate independently in English, Chinese or Malay will be excluded from this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention 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.
- Primary Outcome Measures
Name Time Method Change from baseline Systolic Blood Pressure (SBP) at 12-month 12-month Change of SBP in mmHg
Change from baseline Low-density lipoprotein (LDL) at 12-month 12-month Changes of LDL in mg/dL
Change from baseline High-density lipoprotein (HDL) at 12-month 12-month Changes of HDL in mg/dL
Change from baseline Total cholesterol (TC) at 12-month 12-month Changes of TC in mg/dL
Change from baseline Glycerides (TG) at 12-month 12-month Changes of TG in mg/dL
Incidence of hypoglycaemia 12-month Incidence of hypoglycaemia
Change from baseline Body mass index (BMI) at 6-month baseline and 6-month Change of BMI in kg/m\^2
Change from baseline Glycated Haemoglobin (HbA1c) at 6-month baseline and 6-month Change of HbA1c in %
Changes from baseline Systolic Blood Pressure (SBP) at 6-month baseline and 6-month Change of SBP in mmHg
Change from baseline Body mass index (BMI) at 12 months 12-month Change BMI in kg/m\^2
Change from baseline Glycated Haemoglobin (HbA1c) at 12-month 12-month Changes of HbA1c in %
Change from baseline Low-density lipoprotein (LDL) at 6-month baseline and 6-month Change of LDL in mg/dL
Change from baseline High-density lipoprotein (HDL) at 6-month baseline and 6-month Change of HDL in mg/dL
Change from baseline Total cholesterol (TC) at 6-month baseline and 6-month Change of TC in mg/dL
Change from baseline Glycerides (TG) at 6-month baseline and 6-month Changes of TG in mg/dL
- Secondary Outcome Measures
Name Time Method The 5-level EQ-5D version (5Q-5D-5L) 12-month 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) 12-month 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) 12-month 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) 12-month 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 12-month 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) 12-month 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).
Trial Locations
- Locations (1)
Chua Chu Kang Polyclinic
🇸🇬Singapore, Singapore