Long-term mortality outcome of a primary care-based mobile health intervention for stroke management: Six-year follow-up of a cluster-randomized controlled trial.

IF 15.8 1区 医学 Q1 Medicine
PLoS Medicine Pub Date : 2025-03-27 eCollection Date: 2025-03-01 DOI:10.1371/journal.pmed.1004564
Xingxing Chen, Enying Gong, Jie Tan, Elizabeth L Turner, John A Gallis, Shifeng Sun, Siran Luo, Fei Wu, Bolu Yang, Yutong Long, Yilong Wang, Zixiao Li, Yun Zhou, Shenglan Tang, Janet P Bettger, Brian Oldenburg, Xiaochen Zhang, Jianfeng Gao, Brian S Mittman, Valery L Feigin, Ruitai Shao, Shah Ebrahim, Lijing L Yan
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引用次数: 0

Abstract

Background: Despite growing evidence of primary care-based interventions for chronic disease management in resource-limited settings, long-term post-trial effects remain inconclusive. We investigated the association of a 12-month system-integrated technology-enabled model of care (SINEMA) intervention with mortality outcomes among patients experiencing stroke at 6-year post-trial.

Methods and findings: This study (clinicltiral.gov registration number: NCT05792618) is a long-term passive observational follow-up of participants and their spouse of the SINEMA trial (clinicaltrial.gov registration number: NCT03185858). The original SINEMA trial was a cluster-randomized controlled trial conducted in 50 villages (clusters) in rural China among patients experiencing stroke during July 2017-July 2018. Village doctors in the intervention arm received training, incentives, and a customized mobile health application supporting monthly follow-ups to participants who also received daily free automated voice-messages. Vital status and causes of death were ascertained using local death registry, standardized village doctor records, and verbal autopsy. The post-trial observational follow-up spanned from 13- to 70-months post-baseline (up to April 30, 2023), during which no intervention was requested or supported. The primary outcome of this study was all-cause mortality, with cardiovascular and stroke cause-specific mortality also reported. Cox proportional hazards models with cluster-robust standard errors were used to compute hazard ratios (HRs) and 95% confidence intervals (95% CIs), adjusting for town, age, and sex in the main analysis model. Analyses were conducted on an intention-to-treat basis. Of 1,299 patients experiencing stroke (mean age 65.7 years, 42.6% females) followed-up to 6 years, 276 (21.2%) died (median time-to-death 43.0 months [quantile 1-quantile 3: 26.7-56.8]). Cumulative incidence of all-cause mortality was 19.0% (121 among 637) in the intervention arm versus 23.4% (155 among 662) in the control arm (HR 0.73; 95% CI 0.59, 0.90; p = 0.004); 14.4% versus 17.7% (HR 0.73; 95% CI 0.58, 0.94; p = 0.013) for cardiovascular cause-specific mortality; and 6.0% versus 7.9% (HR 0.71; 95% CI 0.44, 1.15; p = 0.16) for stroke cause-specific mortality. Although multisource verification was used to verify the outcomes, limitations exist as the survey- and record-matching-based nature of the study, unavailability of accurate clinical diagnostic records for some cases and the potential confounders that may influence the observed association on mortality.

Conclusions: Despite no observed statistically difference on stroke cause-specific mortality, the 12-month SINEMA intervention, compared with usual care, significantly associated with reduced all-cause and cardiovascular cause-specific mortality during 6 years of follow-up, suggesting potential sustained long-term benefits to patients experiencing stroke.

以初级保健为基础的卒中管理流动健康干预的长期死亡率结果:一项为期6年的集群随机对照试验随访。
背景:尽管越来越多的证据表明,在资源有限的环境中,以初级保健为基础的干预措施可用于慢性病管理,但长期的试验后效果仍不确定。我们调查了12个月的系统集成技术支持的护理模式(SINEMA)干预与试验后6年中风患者死亡率结果的关系。方法和研究结果:本研究(clinicaltrial.gov注册号:NCT05792618)是对SINEMA试验(clinicaltrial.gov注册号:NCT03185858)参与者及其配偶的长期被动观察随访。最初的SINEMA试验是一项集群随机对照试验,于2017年7月至2018年7月在中国农村的50个村庄(集群)进行,研究对象是中风患者。干预部门的乡村医生接受了培训、奖励和定制的移动医疗应用程序,该应用程序支持每月对参与者进行随访,参与者还每天收到免费的自动语音信息。通过当地死亡登记、标准化的乡村医生记录和死因推断来确定生命状况和死亡原因。试验后观察随访时间为基线后13至70个月(截至2023年4月30日),在此期间未要求或支持干预。这项研究的主要结果是全因死亡率,心血管和中风的病因特异性死亡率也有报道。采用具有聚类稳健性标准误差的Cox比例风险模型计算风险比(hr)和95%置信区间(95% ci),并在主分析模型中调整城镇、年龄和性别。分析是在意向治疗基础上进行的。1299例卒中患者(平均年龄65.7岁,女性占42.6%)随访6年,276例(21.2%)死亡(中位死亡时间43.0个月[分位数1-分位数3:26.7-56.8])。干预组全因死亡率累积发生率为19.0%(637例中有121例),对照组为23.4%(662例中有155例)(HR 0.73;95% ci 0.59, 0.90;p = 0.004);14.4%对17.7% (HR 0.73;95% ci 0.58, 0.94;心血管原因特异性死亡率P = 0.013);6.0%对7.9% (HR 0.71;95% ci 0.44, 1.15;P = 0.16)。虽然使用了多源验证来验证结果,但由于研究基于调查和记录匹配的性质,某些病例无法获得准确的临床诊断记录,以及可能影响观察到的与死亡率相关的潜在混杂因素,因此存在局限性。结论:尽管在脑卒中病因特异性死亡率方面没有观察到统计学差异,但与常规护理相比,12个月的SINEMA干预与6年随访期间全因和心血管病因特异性死亡率的降低显著相关,表明对脑卒中患者有潜在的持续长期益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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