Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Public Health Foundation of India
- Enrollment
- 1120
- Locations
- 10
- Primary Endpoint
- Multiple CVD risk factor control targets
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 35 years and older
- •Confirmed diagnosis of diabetes based on documented evidence from oral glucose tolerance test or two venous fasting blood sugar levels or known diabetes patient on medication or insulin
- •Poor glycemic control (as evidenced by HbA1c \>=8.0%) and one or both of: dyslipidemia \[Low density Lipoprotein (LDL) \>=130 mg/dl\] or systolic hypertension \[Systolic Blood Pressure (SBP) \>=140 mmHg\], irrespective of lipid- or BP-lowering medication use, respectively
- •Receiving diabetes care in the same clinic for at least 3 months OR even earlier if in the investigator's assessment the patient is likely to follow-up regularly as required by the protocol.
- •Willingness to consent to randomization.
Exclusion Criteria
- •Individuals will be excluded from participation if any of the following are present during screening:
- •Known type 1 diabetes mellitus
- •Diabetes secondary to chronic pancreatitis
- •Pregnant OR trying to become pregnant OR of child-bearing potential and not actively practicing birth control (including natural methods)
- •Evidence of pre-existing well-controlled blood glucose, blood pressure or LDL-cholesterol (as evidenced by HbA1c \< 7.0%, SBP \< 130 mmHg, LDL-cholesterol \< 100 mg/dl \[LDL-cholesterol \< 70 mg/dl with history of CVD event\]) obtained from screening within a period not exceeding 28 days (4 weeks) prior to randomization
- •Documented cardiovascular event (coronary revascularization, stroke, MI, unstable angina) in past 12 months
- •Current symptomatic Congestive Heart Failure (CHF) or New York Heart Association (NYHA) Class 3 or 4 effort intolerance
- •Documented non-diabetic kidney disease OR pre-existing end -stage renal disease (on renal replacement therapy \[dialysis or transplant\])
- •Transaminase \>3 times upper limit of normal OR active liver disease within past 2 years
- •Malignancy or life-threatening disease with death probable in 4 years
Outcomes
Primary Outcomes
Multiple CVD risk factor control targets
Time Frame: 42 months after randomization
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)
Secondary Outcomes
- Single risk factor control of at least one target either HbA1c or blood pressure or LDL-Cholesterol(42 months after randomization)
- The cost effectiveness analysis of the intervention compared to the usual care.(42 months after randomization)
- Quality of life(42 months after randomization)
- Prescriber and patient acceptability of the Digital Support software and care coordinator with management guidelines.(42 months after randomization)