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使用PAHcare™数字平台评估肺动脉高压患者的临床获益、安全性及患者报告结局:一项试点研究。

Assessing the clinical benefit, safety, and patient-reported outcomes with the use of the PAHcare™ digital platform in pulmonary arterial hypertension: a pilot study.

作者信息

Peñate Gregorio Pérez, Parra Nuria Ochoa, Morera Juan Antonio Domingo, Meñaca Amaya Martínez, Ramón Marta López, Menéndez Sergio Cadenas, Marrero Fernando León, de la Cal Sara Gómara, Ghadban-Garrido Cristina, Tolosana Patricia Royo, Puentes Javier Martín, Aguayo Rebeca Aldonza, Mahdavi Hadis, Jeanneret Gabriela Bacchini, Subías Pilar Escribano

机构信息

Unidad Multidisciplinar Vascular Pulmonar, Servicio de Neumología, Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria, Spain.

Centro de Investigación Biomédica en Red Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.

出版信息

Front Public Health. 2024 Feb 16;12:1335072. doi: 10.3389/fpubh.2024.1335072. eCollection 2024.

Abstract

INTRODUCTION

Digital health interventions, particularly mobile health platforms, have shown promise in supporting patients with respiratory conditions, but their application in pulmonary arterial hypertension (PAH) remains limited. We aimed to assess the feasibility, acceptability, and potential clinical benefit of the novel PAHcare™ digital platform as a patient-centred intervention for PAH management through a prospective, single-arm, multicenter pilot study conducted on 53 patients diagnosed with PAH who used the platform for 6 months.

METHODS

The primary objective was to assess the impact on Health-Related Quality of Life (HRQoL) through questionnaires. Secondary objectives included evaluating clinical outcomes, including disease progression, PAH signs and symptoms, the 6-min walking test, and the patient's symptom perception. Additionally, we assessed patient satisfaction and engagement with the PAHcare™ platform, interaction with health coaches, retention, costs and healthcare resource utilisation (HCRU), and safety through monitoring device incidents.

RESULTS

Minimal changes in HRQoL and clinical outcomes were observed over 6 months. A noteworthy 92.4% of patients actively used the platform in the first month, maintaining high usage throughout the study. Patient satisfaction was substantial, with more than half of the patients expressing excellence in service quality, willingness to reuse the platform, and fulfilment of their needs. Health coach interaction was high, with 76% of patients initiating contact within the first week. User retention rates were 70%, with prevalent ongoing usage and interaction with healthcare professionals even after the study. In terms of HCRU and costs, the study showed no significant changes in PAH-related hospital admissions, clinical visits, or tests. Finally, the low number of device-related incidents indicated platform safety.

CONCLUSION

This pilot study provides compelling evidence supporting the feasibility and acceptability of the PAHcare™ digital platform to empower patients to manage their disease and significantly enhance their overall experience with PAH.

摘要

引言

数字健康干预措施,尤其是移动健康平台,已显示出在支持呼吸系统疾病患者方面的潜力,但其在肺动脉高压(PAH)中的应用仍然有限。我们旨在通过一项前瞻性、单臂、多中心试点研究,评估新型PAHcare™数字平台作为以患者为中心的PAH管理干预措施的可行性、可接受性和潜在临床益处。该研究对53名诊断为PAH的患者进行,他们使用该平台6个月。

方法

主要目标是通过问卷调查评估对健康相关生活质量(HRQoL)的影响。次要目标包括评估临床结果,包括疾病进展、PAH体征和症状、6分钟步行试验以及患者的症状感知。此外,我们评估了患者对PAHcare™平台的满意度和参与度、与健康教练的互动、留存率、成本和医疗资源利用(HCRU),并通过监测设备事件评估安全性。

结果

在6个月内,HRQoL和临床结果的变化极小。值得注意的是,92.4%的患者在第一个月积极使用该平台,在整个研究过程中保持高使用率。患者满意度很高,超过一半的患者表示服务质量卓越、愿意再次使用该平台以及满足了他们的需求。与健康教练的互动频繁,76%的患者在第一周内就开始联系。用户留存率为70%,即使在研究结束后,仍普遍持续使用该平台并与医疗专业人员互动。在HCRU和成本方面,研究表明与PAH相关的住院、临床就诊或检查没有显著变化。最后,与设备相关的事件数量较少表明平台安全。

结论

这项试点研究提供了有力证据,支持PAHcare™数字平台的可行性和可接受性,该平台能够使患者有能力管理自己的疾病,并显著提升他们在PAH方面的整体体验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e51/10904626/1cdacf6ad2ae/fpubh-12-1335072-g001.jpg

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