Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia (CARRS Translation Trial)
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.


Options:
A: Arm Label: Multi-modal practice intervention; Type: N/A; Interventions: Behavioral: HeartAge intervention | Arm Label: Usual care; Type: N/A; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: HeartAge intervention; Assigned to Arm(s): Multi-modal practice intervention
B: Arm Label: Care coordinator + Decision Support Software; Type: EXPERIMENTAL; Interventions: Other: Care Coordinator + Decision Support Software | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual care | Intervention Type: OTHER; Name: Care Coordinator + Decision Support Software; Assigned to Arm(s): Care coordinator + Decision Support Software | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): Usual care
C: Arm Label: EDUCORE intervention; Type: EXPERIMENTAL; Interventions: Behavioral: EDUCORE intervention | Arm Label: control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Control group | Intervention Type: BEHAVIORAL; Name: EDUCORE intervention; Assigned to Arm(s): EDUCORE intervention | Intervention Type: OTHER; Name: Control group; Assigned to Arm(s): control group
D: Arm Label: COACH; Type: ACTIVE_COMPARATOR; Interventions: Other: COACH | Arm Label: Standard Care; Type: PLACEBO_COMPARATOR; Interventions: Other: No intervention for placebo | Intervention Type: OTHER; Name: COACH; Assigned to Arm(s): COACH | Intervention Type: OTHER; Name: No intervention for placebo; Assigned to Arm(s): Standard Care

Answer: B