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远程患者监测和数字治疗在心力衰竭中的连续性护理中的应用:非随机试点研究。

Remote Patient Monitoring and Digital Therapeutics Enhancing the Continuum of Care in Heart Failure: Nonrandomized Pilot Study.

机构信息

Faculty of Medicine, University of Montreal, Montréal, QC, Canada.

Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.

出版信息

JMIR Form Res. 2024 Nov 6;8:e53444. doi: 10.2196/53444.

Abstract

BACKGROUND

Heart failure (HF) is the primary cause of hospitalization among Canadian patients aged ≥65 years. Care for HF requires regular clinical follow-ups to prevent readmissions and facilitate medical therapy optimization. Multiple barriers lead to therapeutic medical inertia including limited human resources and regional inequities. Remote patient monitoring (RPM) and digital therapeutics (DTx) solutions have been developed to improve HF management, but their adoption remains limited and underexplored. The Continuum project emerged as a collaborative initiative involving a health care center, a software start-up, and an industrial partner.

OBJECTIVE

We aimed to develop and test the feasibility of the Continuum intervention that seamlessly combined an RPM system with a DTx solution for HF within the same software.

METHODS

A 3-month pre-post pilot study was conducted from October 2020 to June 2021. Patients with HF who owned a smartphone or tablet (having remote patient monitoring [RPM+]), had (1) access to a self-care app where they could enter their vital signs, weight, and HF symptoms and view educational content; (2) daily monitoring of their data by a nurse; and (3) a DTx module with automated HF medication suggestions based on national guidelines, made available to their treating medical team. Bluetooth devices were offered to facilitate data recording. Nurses on RPM monitoring could call patients and arrange appointments with their medical team. Patients without a mobile device or unable to use the app were followed in another group (without remote patient monitoring [RPM-]).

RESULTS

In total, 52 patients were enrolled in this study (32 RPM+ and 20 RPM-). Among patients owning a mobile device, only 14% (5/37) could not use the app. In the RPM+ group, 47% (15/32) of the patients used the app for more than 80% (67 days) of the 12-week study period. The use of our digital solution was integrated into the regular nursing workday and only 34 calls had to be made by the nurse during the study period. Only 6% (2/32) of the patients in the RPM+ group experienced at least 1 all-cause hospitalization versus 35% (7/20) of the RPM- ones during the follow-up (6%, 2/32 vs 25%, 5/20 for HF hospitalization) and patients were more likely to have their HF therapy optimized if the DTx solution was available. Quality of life improved in patients compliant with the use of the mobile app (mean score variation +10.6, SD 14.7).

CONCLUSIONS

This pilot study demonstrated the feasibility of implementing our digital solution, within the specific context of HF. The seamless integration of Continuum into nursing workflow, mobile app accessibility, and adoption by patients, were the 3 main key learning points of this study. Further investigation is required to assess the potential impacts on hospitalizations, drug optimization, and quality of life.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05377190; https://clinicaltrials.gov/study/NCT05377190 (pilot study #21.403).

摘要

背景

心力衰竭(HF)是加拿大≥65 岁患者住院的主要原因。HF 的治疗需要定期进行临床随访,以防止再次入院,并促进药物治疗的优化。多种因素导致了治疗性医学惯性,包括有限的人力资源和区域不平等。远程患者监测(RPM)和数字疗法(DTx)解决方案已经被开发出来以改善 HF 管理,但它们的采用仍然有限且未得到充分探索。Continuum 项目是一项合作倡议,涉及一个医疗保健中心、一个软件初创公司和一个工业合作伙伴。

目的

我们旨在开发和测试 Continuum 干预措施的可行性,该干预措施将 RPM 系统与同一软件中的 DTx 解决方案无缝结合,用于 HF。

方法

从 2020 年 10 月至 2021 年 6 月进行了为期 3 个月的预-后试点研究。拥有智能手机或平板电脑(具有远程患者监测[RPM+])的 HF 患者(1)可以访问一个自我护理应用程序,在该应用程序中他们可以输入生命体征、体重和 HF 症状,并查看教育内容;(2)数据由护士每天监测;(3)根据国家指南,为他们的治疗医疗团队提供带有自动化 HF 药物建议的 DTx 模块。提供蓝牙设备以方便数据记录。进行 RPM 监测的护士可以致电患者并为他们安排与医疗团队的预约。没有移动设备或无法使用应用程序的患者在另一组(无远程患者监测[RPM-])中接受随访。

结果

共有 52 名患者参与了这项研究(RPM+组 32 名,RPM-组 20 名)。在拥有移动设备的患者中,只有 14%(5/37)无法使用该应用程序。在 RPM+组中,47%(15/32)的患者在 12 周研究期间使用应用程序超过 80%(67 天)。我们的数字解决方案的使用已整合到常规护理工作日中,在研究期间,护士只需拨打 34 个电话。与 RPM-组相比,只有 6%(2/32)的 RPM+组患者至少经历了 1 次全因住院治疗(HF 住院治疗的 25%,7/20),如果 DTx 解决方案可用,患者更有可能优化 HF 治疗。如果患者遵守使用移动应用程序的规定,生活质量会有所改善(平均评分变化+10.6,SD 14.7)。

结论

这项试点研究证明了在 HF 特定背景下实施我们的数字解决方案的可行性。Continuum 无缝融入护理工作流程、移动应用程序的可及性以及患者的采用,是本研究的 3 个主要学习要点。需要进一步调查以评估其对住院、药物优化和生活质量的潜在影响。

试验注册

ClinicalTrials.gov NCT05377190;https://clinicaltrials.gov/study/NCT05377190(试验 21.403)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e57d/11579625/c2a212835142/formative_v8i1e53444_fig1.jpg

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