Hypertension Clinical Trial
Official title:
Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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