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

doi:10.1161/CIRCULATIONAHA.115.015373

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

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

Authors

Maoyi Tian¹, Vamadevan S Ajay¹, Danzeng Dunzhu¹, Safraj S Hameed¹, Xian Li¹, Zhong Liu¹, Cong Li¹, Hao Chen¹, KaWing Cho¹, Ruilai Li¹, Xingshan Zhao¹, Devraj Jindal¹, Ishita Rawal¹, Mohammed K Ali¹, Eric D Peterson¹, Jiachao Ji¹, Ritvik Amarchand¹, Anand Krishnan¹, Nikhil Tandon¹, Li-Qun Xu¹, Yangfeng Wu¹, Dorairaj Prabhakaran², Lijing L Yan²

Affiliations

¹ From The George Institute for Global Health at Peking University Health Science Center, Beijing, China (M.T., X.L., C.L., R.L., J.J., Y.W., L.L.Y.); Public Health Foundation of India, New Delhi, India (V.S.A., S.S.H., D.P.); Centre for Chronic Disease Control, New Delhi, India (V.S.A., D.J., I.R., D.P.); Tibet University, Lhasa, China (D.D., Z.L.); Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China (C.L., Y.W.); Department of Cardiology, Beijing Hospital, China (H.C.); Children's Hospital Los Angeles, CA (K.W.C.); Department of Cardiology, Jishuitan Hospital, Beijing, China (X.Z.); Rollins School of Public Health, Emory University, Atlanta, GA (M.K.A.); Duke Clinical Research Institute, Duke University, Durham, NC (E.D.P.); Department of Community Medicine, All India Institute of Medical Sciences, New Delhi, India (R.A., A.K.); Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India (N.T.); China Mobile Research Institute, Beijing, China (L.X.); and Duke Global Health Institute, and Global Health Research Center, Duke Kunshan University, Kunshan, China (L.L.Y.).
² From The George Institute for Global Health at Peking University Health Science Center, Beijing, China (M.T., X.L., C.L., R.L., J.J., Y.W., L.L.Y.); Public Health Foundation of India, New Delhi, India (V.S.A., S.S.H., D.P.); Centre for Chronic Disease Control, New Delhi, India (V.S.A., D.J., I.R., D.P.); Tibet University, Lhasa, China (D.D., Z.L.); Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China (C.L., Y.W.); Department of Cardiology, Beijing Hospital, China (H.C.); Children's Hospital Los Angeles, CA (K.W.C.); Department of Cardiology, Jishuitan Hospital, Beijing, China (X.Z.); Rollins School of Public Health, Emory University, Atlanta, GA (M.K.A.); Duke Clinical Research Institute, Duke University, Durham, NC (E.D.P.); Department of Community Medicine, All India Institute of Medical Sciences, New Delhi, India (R.A., A.K.); Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India (N.T.); China Mobile Research Institute, Beijing, China (L.X.); and Duke Global Health Institute, and Global Health Research Center, Duke Kunshan University, Kunshan, China (L.L.Y.). [email protected] [email protected].

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.

Publication types

Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Cardiovascular Diseases / diagnosis
Cardiovascular Diseases / ethnology*
Cardiovascular Diseases / therapy*
China / ethnology
Cluster Analysis
Disease Management*
Female
Follow-Up Studies
Humans
India / ethnology
Internationality*
Male
Middle Aged
Patient Education as Topic / methods
Risk Factors
Rural Population*
Single-Blind Method
Tibet / ethnology

Associated data

ClinicalTrials.gov/NCT01503814

Abstract

Publication types

MeSH terms

Associated data

Grants and funding