Public Health Foundation of India (PHFI), All India Institute of Medical Sciences (AIIMS), Madras Diabetes Research Foundation (MDRF) and EMORY University of USA are working together and have established a Centre of Excellence (COE) in cardiometabolic diseases namely 'Center of Excellence - Center for cArdio-metabolic Risk Reduction in South Asia (CARRS)' with support from the National Heart, Lung and Blood Institute (NHLBI) of USA. The COE-CARRS housed at PHFI is one of eleven centers in the world that is supported through the Global Health Initiative of NHLBI and the UnitedHealth Chronic Disease Initiative.

As part of COE-CARRS, two major studies are being conducted:

1. CARRS - Surveillance Study (Development & Evaluation of a Model Sentinel Surveillance System in South Asia)

This is a cohort-modelled surveillance study. While the primary study design for the surveillance model is cross-sectional, a cohort study design will be used to follow-up the participants for three years subsequently. The study aims to develop a model surveillance system for Cardio Metabolic Diseases (CMD) and its risk factors which can be adopted for continuing surveillance both within and across countries in South Asia and to measure the incidence of CMD risk factors and disease events, as well as the associated morbidity and mortality.

Objectives of the study:

Primary objectives

• To implement and evaluate a model surveillance system in two study sites in India namely; Delhi and Chennai and one study site in Pakistan; Karachi, which is collaborating with Emory University.
• To assess the prevalence of CMD risk factors and diseases among adults aged 20 years and above, permanently residing in well-defined urban communities in the three study sites
• Ascertain factors that influence knowledge, attitudes, and practice (KAP) of the sample population regarding CMD and their risk factors

Secondary objectives

• Determine the incidence of intermediate risk factors (in previously risk-free individuals), new-onset complications, and the associated morbidity and mortality
• To derive cost and health-utilization indices which can be used to model projected burdens of CMD in order to formulate cost-effective and timely interventions

2. CARRS - Translation Trial (Developing and Testing Integrated, Multi-factorial Cardiovascular Disease Risk Reduction Strategies in South Asia)

The study is a multi-site, individually randomized, controlled translation trial of a cardiovascular risk reduction intervention in 1,120 Type 2 diabetes patients attending 8 established out-patient clinics in South Asia, for a mean follow-up of 30 months. Half of the patients will be randomized to the intervention, which utilizes a combination of health care management strategies: (1) a web-enhanced decision-support software that serves to store patient health records; provide patient management advice; and prompt and remind care providers and participants of recommended care processes; and (2) a non-physician care coordinator to facilitate physician adherence to evidence-based management guidelines and aid in patient self-management.

Objective of the study:

• To test the effectiveness and sustainability of a comprehensive cardiovascular disease (CVD) risk reduction intervention, using clinical decision-support software and non-physician care coordinators, in Type 2 diabetes patients attending out-patient clinics in South Asia, compared to standard care.

COE-CARRS is accredited as a Fogarty International Clinical Research (FICR) Fellows and Scholars site. It consists of a carefully-constructed consortium of world-class investigators and institutions, and aims to build a global research hub. In addition to the India collaborators, National Center for Chronic Diseases (NCCD) of the U.S. Centers for Disease Control and Prevention (CDC) is a strategic partner. The experience and breadth of knowledge of the investigators, combined with rich traditions of research and training among partner institutions, will enable this COE to contribute to enhancing CMD research capacity in the region, and generate new collaborative relationships.