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.
<h4>Background</h4>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...
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Public Library of Science (PLoS)
2025-03-01
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| Online Access: | https://doi.org/10.1371/journal.pmed.1004564 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Xingxing Chen |
| collection | DOAJ |
| description | <h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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. |
| format | Article |
| id | doaj-art-3bc1a53b4d634588a3761dfce1d1f04b |
| institution | DOAJ |
| issn | 1549-1277 1549-1676 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Medicine |
| spelling | doaj-art-3bc1a53b4d634588a3761dfce1d1f04b2025-08-20T03:17:51ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762025-03-01223e100456410.1371/journal.pmed.1004564Long-term mortality outcome of a primary care-based mobile health intervention for stroke management: Six-year follow-up of a cluster-randomized controlled trial.Xingxing ChenEnying GongJie TanElizabeth L TurnerJohn A GallisShifeng SunSiran LuoFei WuBolu YangYutong LongYilong WangZixiao LiYun ZhouShenglan TangJanet P BettgerBrian OldenburgXiaochen ZhangJianfeng GaoBrian S MittmanValery L FeiginRuitai ShaoShah EbrahimLijing L Yan<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.https://doi.org/10.1371/journal.pmed.1004564 |
| spellingShingle | 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 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. PLoS Medicine |
| title | 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. |
| title_full | 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. |
| title_fullStr | 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. |
| title_full_unstemmed | 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. |
| title_short | 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. |
| title_sort | 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 |
| url | https://doi.org/10.1371/journal.pmed.1004564 |
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