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远程ILD 研究:一项多中心、12 个月随机对照试验的方案描述,旨在评估远程监测间质性肺疾病患者的肺量计和脉搏血氧饱和度的临床和成本效益。

REMOTE-ILD study: Description of the protocol for a multicentre, 12-month randomised controlled trial to assess the clinical and cost-effectiveness of remote monitoring of spirometry and pulse oximetry in patients with interstitial lung disease.

机构信息

Respiratory Medicine, Imperial College Healthcare NHS Trust, London, UK

National Heart and Lung Institute, Imperial College London, London, UK.

出版信息

BMJ Open Respir Res. 2024 Feb 28;11(1):e002067. doi: 10.1136/bmjresp-2023-002067.

DOI:10.1136/bmjresp-2023-002067
PMID:38418384
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10910426/
Abstract

INTRODUCTION

Remote monitoring of home physiological measurements has been proposed as a solution to support patients with chronic diseases as well as facilitating virtual consultations and pandemic preparedness for the future. Daily home spirometry and pulse oximetry have been demonstrated to be safe and acceptable to patients with interstitial lung disease (ILD) but there is currently limited evidence to support its integration into clinical practice.

AIM

Our aim is to understand the clinical utility of frequent remote physiological measurements in ILD and the impact of integrating these into clinical practice from a patient, clinical and health economic perspective.

METHODS AND ANALYSIS

132 patients with fibrotic ILD will be recruited and randomised to receive either usual care with remote digital monitoring of home spirometry and pulse oximetry or usual care alone for 12 months. All participants will complete health-related quality of life and experience questionnaires.The primary outcome compares the availability of spirometry measurements within the 2 weeks preceding planned clinic appointments. Secondary outcomes will explore other aspects of clinical and cost-effectiveness of the remote monitoring programme.

ETHICS AND DISSEMINATION

The study has been approved by the Camden and Kings Cross Research Ethics Committee (22/LO/0309). All participants will provide informed consent.This study is registered with www.

CLINICALTRIALS

gov (NCT05662124).The results of the study will be submitted for presentation at regional and national conferences and submitted for peer-reviewed publication. Reports will be prepared for study participants with the support from our public involvement representatives through the charity Action for Pulmonary Fibrosis.

摘要

简介

远程监测家庭生理测量已被提出作为一种解决方案,以支持慢性病患者,并为未来的虚拟咨询和大流行做好准备。已经证明,每日家庭肺量计和脉搏血氧饱和度测量对间质性肺疾病(ILD)患者是安全且可接受的,但目前支持将其纳入临床实践的证据有限。

目的

我们的目的是从患者、临床和健康经济的角度了解ILD 中频繁进行远程生理测量的临床实用性,以及将这些测量纳入临床实践的影响。

方法和分析

将招募 132 名纤维化ILD 患者,并将其随机分为接受常规护理加远程数字监测家庭肺量计和脉搏血氧饱和度监测组或仅接受常规护理组,为期 12 个月。所有参与者都将完成与健康相关的生活质量和体验问卷。主要结果比较在计划就诊前 2 周内提供肺量计测量的情况。次要结果将探索远程监测计划的其他临床和成本效益方面。

伦理和传播

该研究已获得卡姆登和国王十字研究伦理委员会(22/LO/0309)的批准。所有参与者都将提供知情同意。本研究在 www.clinicaltrials.gov 上注册(NCT05662124)。该研究的结果将提交给地区和国家会议,并提交给同行评审的出版物。报告将在慈善机构 Action for Pulmonary Fibrosis 的支持下,由我们的公众参与代表为研究参与者编写。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a346/10910426/7f591222dd76/bmjresp-2023-002067f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a346/10910426/7f591222dd76/bmjresp-2023-002067f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a346/10910426/7f591222dd76/bmjresp-2023-002067f01.jpg

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