Bin Peng1, Jun Ni, Craig S Anderson, Yicheng Zhu, Yongjun Wang, Chuanqiang Pu, Jiang Wu, Jianming Wang, Lixin Zhou, Ming Yao, Jia He, Guangliang Shan, Shan Gao, Weihai Xu, Liying Cui. 1. From the Department of Neurology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China (B.P., J.N., Y.Z., J. Wang, L.Z., M.Y., S.G., W.X., L.C.); The George Institute for Global Health, Royal Prince Alfred Hospital and University of Sydney, Sydney, Australia (C.S.A.); Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China (Y.W.); Department of Neurology, People's Liberation Army General Hospital, Beijing, China (C.P.); Department of Neurology, Jilin University, Changchun, China (J. Wu); Department of Health Statistics, Second Military Medical University (J.H.); Department of Epidemiology, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences; and School of Basic Medicine, Peking Union Medical College, Beijing, China (G.S.).
Abstract
BACKGROUND AND PURPOSE: High rates of ischemic stroke and poor adherence to secondary prevention measures are observed in the Chinese population. METHODS: We used a national, multicenter, cluster-randomized controlled trial in which 47 hospitals were randomized to either a structured care program group (n=23) or a usual care group (n=24). The structured care program consisted of a specialist-administered, guideline-recommended pharmaceutical treatment and a lifestyle modification algorithm associated with written and Internet-accessed educational material for patients for the secondary prevention of ischemic stroke. The primary efficacy outcome was the proportion of patients who adhered to the recommended measures at 12-month postdischarge. This trial is registered with ClinicalTrial.gov (NCT00664846). RESULTS: At 12 months, 1287 (72.1%) patients in the Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART) group and 1430 (72%) patients in the usual care group had completed the 12-month follow-up (P=0.342). Compared with the usual care group, those in the SMART group showed higher adherence to statins (56% versus 33%; P=0.006) but no difference in adherence to antiplatelet (81% versus 75%; P=0.088), antihypertensive (67% versus 69%; P=0.661), or diabetes mellitus drugs (73% versus 67%; P=0.297). No significant difference in the composite end point (new-onset ischemic stroke, hemorrhagic stroke, acute coronary syndrome, and all-cause death) was observed (3.56% versus 3.59%; P=0.921). CONCLUSIONS: The implementation of a program to improve adherence to secondary ischemic stroke prevention efforts in China is feasible, but these programs had only a limited impact on adherence and no impact on 1-year outcomes. Further development of a structured program to reduce vascular events after stroke is needed. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00664846.
RCT Entities:
BACKGROUND AND PURPOSE: High rates of ischemic stroke and poor adherence to secondary prevention measures are observed in the Chinese population. METHODS: We used a national, multicenter, cluster-randomized controlled trial in which 47 hospitals were randomized to either a structured care program group (n=23) or a usual care group (n=24). The structured care program consisted of a specialist-administered, guideline-recommended pharmaceutical treatment and a lifestyle modification algorithm associated with written and Internet-accessed educational material for patients for the secondary prevention of ischemic stroke. The primary efficacy outcome was the proportion of patients who adhered to the recommended measures at 12-month postdischarge. This trial is registered with ClinicalTrial.gov (NCT00664846). RESULTS: At 12 months, 1287 (72.1%) patients in the Standard Medical Management in Secondary Prevention of Ischemic Stroke in China (SMART) group and 1430 (72%) patients in the usual care group had completed the 12-month follow-up (P=0.342). Compared with the usual care group, those in the SMART group showed higher adherence to statins (56% versus 33%; P=0.006) but no difference in adherence to antiplatelet (81% versus 75%; P=0.088), antihypertensive (67% versus 69%; P=0.661), or diabetes mellitus drugs (73% versus 67%; P=0.297). No significant difference in the composite end point (new-onset ischemic stroke, hemorrhagic stroke, acute coronary syndrome, and all-cause death) was observed (3.56% versus 3.59%; P=0.921). CONCLUSIONS: The implementation of a program to improve adherence to secondary ischemic stroke prevention efforts in China is feasible, but these programs had only a limited impact on adherence and no impact on 1-year outcomes. Further development of a structured program to reduce vascular events after stroke is needed. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT00664846.
Authors: Peter M Hession; Cynthia J Millward; Joyce E Gottesfeld; Thomas F Rehring; Kevin B Miller; Paul M Chetham; S Kel Muckleroy; Christopher A Bates; Harris W Hollis Journal: Perm J Date: 2016-08-17
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