Enying Gong1, Wanbing Gu2, Cheng Sun2, Elizabeth L Turner3, Yun Zhou4, Zixiao Li4, Janet Prvu Bettger5, Brian Oldenburg6, Alba Amaya-Burns2, Yilong Wang4, Li-Qun Xu7, Jianmin Yao8, Dejin Dong9, Zhenli Xu10, Chaoyun Li2, Mobai Hou11, Lijing L Yan12. 1. Global Health Research Center, Duke Kunshan University, Jiangsu, China; School of Population and Global Health, The University of Melbourne, Victoria, Australia. 2. Global Health Research Center, Duke Kunshan University, Jiangsu, China. 3. Duke Global Health Institute, Duke University, North Carolina; Department of Biostatistics & Bioinformatics, Duke University, North Carolina. 4. Beijing Tiantan Hospital, Capital Medical University, Beijing, China. 5. Duke Global Health Institute, Duke University, North Carolina; Department of Orthopedic Surgery, Duke University, North Carolina. 6. School of Population and Global Health, The University of Melbourne, Victoria, Australia. 7. Center of Excellence for mHealth and Smart Healthcare, China Mobile Research Institute, Beijing, China. 8. Nanhe County People Hospital, Hebei, China. 9. Xingtai Center for Disease Control and Prevention, Hebei, China. 10. Nanhe Center for Disease Control and Prevention, Hebei, China. 11. Health Bureau of Nanhe County, Hebei, China. 12. Global Health Research Center, Duke Kunshan University, Jiangsu, China; Duke Global Health Institute, Duke University, North Carolina. Electronic address: Lijing.yan@duke.edu.
Abstract
BACKGROUND: Despite the significant burden of stroke in rural China, secondary prevention of stroke is suboptimal. This study aims to develop a SINEMA for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model compared with usual care. METHODS: The SINEMA model is being implemented and evaluated through a 1-year cluster-randomized controlled trial in Nanhe County, Hebei Province in China. Fifty villages from 5 townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual care) with a target to enroll 25 stroke survivors per village. Village doctors in the intervention arm (1) receive systematic cascade training by stroke specialists on clinical guidelines, essential medicines and behavior change; (2) conduct monthly follow-up visits with the support of a mobile phone application designed for this study; (3) participate in virtual group activities with other village doctors; 4) receive performance feedback and payment. Stroke survivors participate in a health education and project briefing session, receive monthly follow-up visits by village doctors and receive a voice message call daily as reminders for medication use and physical activities. Baseline and 1-year follow-up survey will be conducted in all villages by trained staff who are blinded of the randomized allocation of villages. The primary outcome will be systolic blood pressure and the secondary outcomes will include diastolic blood pressure, medication adherence, mobility, physical activity level and quality of life. Process and economic evaluation will also be conducted. DISCUSSION: This study is one of very few that aim to promote secondary prevention of stroke in resource-constrained settings and the first to incorporate mobile technologies for both healthcare providers and patients in China. The SINEMA model is innovative as it builds the capacity of primary healthcare workers in the rural area, uses mobile health technologies at the point of care, and addresses critical health needs for a vulnerable community-dwelling patient group. The findings of the study will provide translational evidence for other resource-constrained settings in developing strategies for the secondary prevention of stroke.
RCT Entities:
BACKGROUND: Despite the significant burden of stroke in rural China, secondary prevention of stroke is suboptimal. This study aims to develop a SINEMA for the secondary prevention of stroke in rural China and to evaluate the effectiveness of the model compared with usual care. METHODS: The SINEMA model is being implemented and evaluated through a 1-year cluster-randomized controlled trial in Nanhe County, Hebei Province in China. Fifty villages from 5 townships are randomized in a 1:1 ratio to either the intervention or the control arm (usual care) with a target to enroll 25 stroke survivors per village. Village doctors in the intervention arm (1) receive systematic cascade training by stroke specialists on clinical guidelines, essential medicines and behavior change; (2) conduct monthly follow-up visits with the support of a mobile phone application designed for this study; (3) participate in virtual group activities with other village doctors; 4) receive performance feedback and payment. Stroke survivors participate in a health education and project briefing session, receive monthly follow-up visits by village doctors and receive a voice message call daily as reminders for medication use and physical activities. Baseline and 1-year follow-up survey will be conducted in all villages by trained staff who are blinded of the randomized allocation of villages. The primary outcome will be systolic blood pressure and the secondary outcomes will include diastolic blood pressure, medication adherence, mobility, physical activity level and quality of life. Process and economic evaluation will also be conducted. DISCUSSION: This study is one of very few that aim to promote secondary prevention of stroke in resource-constrained settings and the first to incorporate mobile technologies for both healthcare providers and patients in China. The SINEMA model is innovative as it builds the capacity of primary healthcare workers in the rural area, uses mobile health technologies at the point of care, and addresses critical health needs for a vulnerable community-dwelling patient group. The findings of the study will provide translational evidence for other resource-constrained settings in developing strategies for the secondary prevention of stroke.
Authors: Lijing L Yan; Enying Gong; Wanbing Gu; Elizabeth L Turner; John A Gallis; Yun Zhou; Zixiao Li; Kara E McCormack; Li-Qun Xu; Janet P Bettger; Shenglan Tang; Yilong Wang; Brian Oldenburg Journal: PLoS Med Date: 2021-04-28 Impact factor: 11.069
Authors: Enying Gong; Lixin Sun; Qian Long; Hanzhang Xu; Wanbing Gu; Janet Prvu Bettger; Jingru Tan; Jixiang Ma; Tazeen Hasan Jafar; Brian Oldenburg; Lijing L Yan Journal: Front Public Health Date: 2021-11-17
Authors: Daniela C Gonçalves-Bradley; Ana Rita J Maria; Ignacio Ricci-Cabello; Gemma Villanueva; Marita S Fønhus; Claire Glenton; Simon Lewin; Nicholas Henschke; Brian S Buckley; Garrett L Mehl; Tigest Tamrat; Sasha Shepperd Journal: Cochrane Database Syst Rev Date: 2020-08-18