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: Active Control Group (ACG); Type: OTHER; Interventions: Device: Accu-Chek Aviva Glucose Meter | Arm Label: Structured Testing Group (STG); Type: EXPERIMENTAL; Interventions: Device: Accu-Chek 360° View Blood Glucose Analysis Tool, Device: Accu-Chek Aviva Glucose Meter | Intervention Type: DEVICE; Name: Accu-Chek 360° View Blood Glucose Analysis Tool; Assigned to Arm(s): Structured Testing Group (STG) | Intervention Type: DEVICE; Name: Accu-Chek Aviva Glucose Meter; Assigned to Arm(s): Active Control Group (ACG), Structured Testing Group (STG)
B: Arm Label: online mutual management; Type: EXPERIMENTAL; Interventions: Device: Welltang App | Arm Label: online self-management; Type: EXPERIMENTAL; Interventions: Device: Welltang App | Arm Label: hospital regular management; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Welltang App; Assigned to Arm(s): online mutual management, online self-management
C: Arm Label: T2DM patients seen in routine practice; Type: N/A; Interventions: Other: No treatment given | Intervention Type: OTHER; Name: No treatment given; Assigned to Arm(s): T2DM patients seen in routine practice
D: 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

Answer: D