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Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA) study protocol.
International Journal of Stroke ( IF 6.3 ) Pub Date : 2019-12-18 , DOI: 10.1177/1747493019895653
Mahesh Pundlik Kate 1 , Deepti Arora 1 , Shweta Jain Verma 1 , P N Sylaja 2 , Vishnu Renjith 2 , Meenakshi Sharma 3 , Jeyaraj Durai Pandian 1 ,
Affiliation  

RATIONALE Recurrent stroke, cardiovascular morbidity, and mortality are important causes of poor outcome in patients with index stroke. Despite the availability of best medical management recurrent stroke occur in up to 15-20% of patients with stroke in India. Education for stroke prevention could be a strategy to prevent recurrent strokes. HYPOTHESIS We hypothesize that a structured semi-interactive stroke prevention package can reduce the risk of recurrent strokes, acute coronary artery syndrome, and death in patients with sub-acute stroke at the end of one year. DESIGN Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in INDIA (SPRINT INDIA) is a multi-center stroke trial involving 25 centers under the Indian Stroke Clinical Trial Network. Patients with first ever sub-acute stroke within two days to three months of onset, age 18-85 years, mRS <5, showing recent stroke in imaging are included. Participants or caregivers able to read and complete tasks suggested in a stroke prevention workbook and have a cellular device for receiving short message service and watching videos. A total of 5830 stroke patients speaking 11 different languages are being randomized to intervention or control arm. Patients in the intervention arm are receiving a stroke prevention workbook, regular educational short messages, and videos. All patients in the control arm are receiving standard of care management. SUMMARY Structured semi-interactive stroke prevention package may reduce the risk of recurrent strokes, acute coronary artery syndrome, and death in patients with sub-acute stroke. TRIAL REGISTRATION This trial is registered with clinicaltrials.gov (NCT03228979) and CTRI (Clinical Trial Registry India; CTRI/2017/09/009600).

中文翻译:


印度结构化半交互式中风预防包(SPRINT INDIA)研究方案的二级预防。



基本原理 复发性卒中、心血管发病率和死亡率是中风患者预后不良的重要原因。尽管有最好的医疗管理,印度仍有高达 15-20% 的中风患者会复发中风。中风预防教育可能是预防中风复发的策略。假设我们假设结构化半交互式中风预防方案可以降低亚急性中风患者一年后复发中风、急性冠状动脉综合征和死亡的风险。印度的结构化半交互式中风预防包设计二级预防 (SPRINT INDIA) 是一项多中心中风试验,涉及印度中风临床试验网络下的 25 个中心。包括发病后两天至三个月内首次亚急性卒中、年龄18-85岁、mRS <5、影像学显示近期卒中的患者。参与者或护理人员能够阅读并完成中风预防工作簿中建议的任务,并拥有用于接收短信服务和观看视频的蜂窝设备。共有 5830 名讲 11 种不同语言的中风患者被随机分配到干预组或对照组。干预组的患者正在收到中风预防工作簿、定期教育短信和视频。对照组的所有患者都正在接受标准的护理管理。摘要 结构化半交互式中风预防包可以降低亚急性中风患者复发中风、急性冠状动脉综合征和死亡的风险。试验注册 该试验已在 ClinicalTrials.gov (NCT03228979) 和 CTRI(印度临床试验注册中心;CTRI/2017/09/009600)注册。
更新日期:2020-02-04
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