Background: Cardiovascular diseases (CVD) are currently the leading cause of death globally and Asian Indians will account for between 40-60% of the global CVD burden within the next 10-15 years. Risk factor control and preventive care are effective in reducing CVD events and mortality. The greatest gains in CVD prevention have been seen when early and target-driven interventions address multiple risk factors together. However, achieving control of even individual risk factors (blood glucose, blood pressure, or blood lipid targets) is poor, globally. Quality improvement schemes, like the proposed intervention, have shown promise in high-income countries, but are untested in South Asia; a region with a population at extraordinarily high CVD risk. Objective: To test whether a clinic-based case management intervention (consisting of guidelines based treatment, care coordinator assistance and decision support software) to reduce cardiovascular disease (CVD) risk among Type 2 diabetes patients in South Asia, is more effective and sustainable compared to existing care. Trial subjects and methods: The study will involve a total of 1120 patients attending 8 established out-patient clinics in South Asia (140 patients at each clinic). Patients enrolled in the trial will be randomly assigned to either the control (existing care) or the intervention group and will be followed up for an average of 30 months. The total trial duration is about 3.5 years, from mid-August 2010 to December 31, 2013.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,120
Care coordinator + Decision Support Software (Experimental Arm): The patients will receive integrated diabetes care management consisting of current diabetes management guidelines + Non-Physician care coordinator assistance + Electronic Health Records- Decision Support Software (EHR-DSS) (The software will generate diabetes management prompts for the treating physician and reminders for clinic visits for the intervention arm patients.)
Usual care (Active Comparator Arm): Patients will continue with the usual diabetes care with no care coordinator assistance and no decision support software - management prompt.
Bangalore Endocrinology and Diabetes Research Centre,
#35, 5th Cross,Malleswaram Circle,, Bangalore, Karnataka, India
RECRUITINGSt. John's Medical College & Hospital,
Sarjapur Road, Koramangala,, Bangalore, India
RECRUITINGDiabetes Research Centre & MV Hospital for Diabetes,
No 4 West Madha Church Street, Royapuram, Chennai, India
RECRUITINGEndocrine Division, Department of Medicine, Goa Medical College,
Bambolim, Goa, India
NOT_YET_RECRUITINGDepartment of Endocrinology, CARE Hospital,
Road No 1, Banjara Hills,, Hyderabad,, India
RECRUITINGOsmania General Hospital,
2nd Floor, Golden Jubilee Block, Afzalgunj,, Hyderabad, India
RECRUITINGAmrita Institute of Medical Sciences
Kochi, Kerala, India
RECRUITINGTopiwala National Medical College & BYL Nair Ch. Hospital,
Dr. A. L. Nair Road, Mumbai Central,, Mumbai, India
RECRUITINGPublic Health Foundation of India
New Delhi, National Capital Territory of Delhi, India
RECRUITINGDepartment of CHS, The Aga Khan, University,
P.O. BOx. 3500 Stadium, Road,, Karachi, Pakistan
RECRUITINGMultiple CVD risk factor control targets
The study has one primary outcome of interest, multiple CVD risk factor control targets: at least two targets including Hemoglobin A1c (HbA1c) \< 7.0% and at least one of: Blood Pressure (BP) \< 130/80 mmHg or Low Density Lipoprotein (LDL)-cholesterol \< 100 mg/dl (LDL cholesterol \< 70 mg/dl for those with history of CVD event)
Time frame: 42 months after randomization
Single risk factor control of at least one target either HbA1c or blood pressure or LDL-Cholesterol
Single risk factor control 1. absolute 10% point greater proportion of participants in the intervention group achieving good glycemic control (HbA1c \< 7%) 2. systolic BP \< 130 and diastolic BP \< 80 mmHg 3. LDL-cholesterol \< 100 mg/dl, \< 70 mg/dl for those with history of CVD event)
Time frame: 42 months after randomization
The cost effectiveness analysis of the intervention compared to the usual care.
Time frame: 42 months after randomization
Quality of life
Time frame: 42 months after randomization
Prescriber and patient acceptability of the Digital Support software and care coordinator with management guidelines.
Time frame: 42 months after randomization
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