A Cluster-Randomized, Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India

Abstract

Background: In rural areas in China and India, the cardiovascular disease burden is high but economic and healthcare resources are limited. This study (the Simplified Cardiovascular Management Study [SimCard]) aims to develop and evaluate a simplified cardiovascular management program delivered by community health workers with the aid of a smartphone-based electronic decision support system.

Methods and results: The SimCard study was a yearlong cluster-randomized, controlled trial conducted in 47 villages (27 in China and 20 in India). Recruited for the study were 2086 individuals with high cardiovascular risk (aged ≥40 years with self-reported history of coronary heart disease, stroke, diabetes mellitus, and/or measured systolic blood pressure ≥160 mm Hg). Participants in the intervention villages were managed by community health workers through an Android-powered app on a monthly basis focusing on 2 medication use and 2 lifestyle modifications. In comparison with the control group, the intervention group had a 25.5% (P<0.001) higher net increase in the primary outcome of the proportion of patient-reported antihypertensive medication use pre- and post-intervention. There were also significant differences in certain secondary outcomes: aspirin use (net difference: 17.1%; P<0.001) and systolic blood pressure (-2.7 mm Hg; P=0.04). However, no significant changes were observed in the lifestyle factors. The intervention was culturally tailored, and country-specific results revealed important differences between the regions.

Conclusions: The results indicate that the simplified cardiovascular management program improved quality of primary care and clinical outcomes in resource-poor settings in China and India. Larger trials in more places are needed to ascertain the potential impacts on mortality and morbidity outcomes.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01503814.

Keywords: China; India; cardiovascular diseases; community; decision support techniques; prevention & control.

© 2015 American Heart Association, Inc.

Figures

Figure 1

Trial Flow Chart.

Figure 2

Effect of the simplified management program on the primary outcome among high risk individuals. ^: Anti-hypertensive medication use in the past month is defined as self-reported use of community healthcare workers-prescribed anti-hypertensive medication for ≥ 25 days in the past month. #: The interaction between China and India was significant (P

Figure 2

Effect of the simplified management program on the primary outcome among high risk individuals. ^: Anti-hypertensive medication use in the past month is defined as self-reported use of community healthcare workers-prescribed anti-hypertensive medication for ≥ 25 days in the past month. #: The interaction between China and India was significant (P

Figure 2

Effect of the simplified management program on the primary outcome among high risk individuals. ^: Anti-hypertensive medication use in the past month is defined as self-reported use of community healthcare workers-prescribed anti-hypertensive medication for ≥ 25 days in the past month. #: The interaction between China and India was significant (P

Figure 2

Effect of the simplified management program on the primary outcome among high risk individuals. ^: Anti-hypertensive medication use in the past month is defined as self-reported use of community healthcare workers-prescribed anti-hypertensive medication for ≥ 25 days in the past month. #: The interaction between China and India was significant (P