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Randomized Controlled Trial
. 2015 Sep 1;132(9):815-24.
doi: 10.1161/CIRCULATIONAHA.115.015373. Epub 2015 Jul 17.

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

Maoyi Tian  1 , Vamadevan S Ajay  1 , Danzeng Dunzhu  1 , Safraj S Hameed  1 , Xian Li  1 , Zhong Liu  1 , Cong Li  1 , Hao Chen  1 , KaWing Cho  1 , Ruilai Li  1 , Xingshan Zhao  1 , Devraj Jindal  1 , Ishita Rawal  1 , Mohammed K Ali  1 , Eric D Peterson  1 , Jiachao Ji  1 , Ritvik Amarchand  1 , Anand Krishnan  1 , Nikhil Tandon  1 , Li-Qun Xu  1 , Yangfeng Wu  1 , Dorairaj Prabhakaran  2 , Lijing L Yan  2
Affiliations
Randomized Controlled Trial

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

Maoyi Tian et al. Circulation. .

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.

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Figures

Figure 1
Figure 1
Trial Flow Chart.
Figure 2
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<0.01). *: P-value for the net difference of pre-and-post intervention between the groups.
Figure 2
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<0.01). *: P-value for the net difference of pre-and-post intervention between the groups.
Figure 2
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<0.01). *: P-value for the net difference of pre-and-post intervention between the groups.
Figure 2
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<0.01). *: P-value for the net difference of pre-and-post intervention between the groups.
See this image and copyright information in PMC

Comment in

  • Power of the Cluster.
    Lauer MS, Mensah GA. Lauer MS, et al. Circulation. 2015 Sep 1;132(9):794-5. doi: 10.1161/CIRCULATIONAHA.115.018142. Epub 2015 Jul 17. Circulation. 2015. PMID: 26187184 Free PMC article. No abstract available.

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