Division of Intramural Research, National Institute on Minority Health and Health Disparities, National Institutes of Health, Rockville, MD, United States.
Biostrap USA, LLC, Lakeway, TX, United States.
JMIR Res Protoc. 2024 Aug 16;13:e57382. doi: 10.2196/57382.
Postacute sequelae of COVID-19 (PASC) remain understudied in nonhospitalized patients. Digital wearables allow for a continuous collection of physiological parameters such as respiratory rate and oxygen saturation that have been predictive of disease trajectories in hospitalized patients.
This protocol outlines the design and procedures of a prospective, longitudinal, observational study of PASC that aims to identify wearables-collected physiological parameters that are associated with PASC in patients with a positive diagnosis.
This is a single-arm, prospective, observational study of a cohort of 550 patients, aged 18 to 65 years, male or female, who own a smartphone or a tablet that meets predetermined Bluetooth version and operating system requirements, speak English, and provide documentation of a positive COVID-19 test issued by a health care professional within 5 days before enrollment. The primary end point is long COVID-19, defined as ≥1 symptom at 3 weeks beyond the first symptom onset or positive diagnosis, whichever comes first. The secondary end point is chronic COVID-19, defined as ≥1 symptom at 12 weeks beyond the first symptom onset or positive diagnosis. Participants must be willing and able to consent to participate in the study and adhere to study procedures for 6 months.
The first patient was enrolled in October 2021. The estimated year for publishing the study results is 2025.
This is a fully decentralized study investigating PASC using wearable devices to collect physiological parameters and patient-reported outcomes. The study will shed light on the duration and symptom manifestation of PASC in nonhospitalized patient subgroups and is an exemplar of the use of wearables as population-level monitoring health tools for communicable diseases.
ClinicalTrials.gov NCT04927442; https://clinicaltrials.gov/study/NCT04927442.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57382.
COVID-19 的急性后期（PASC）在非住院患者中仍研究不足。数字可穿戴设备可以连续收集呼吸频率和血氧饱和度等生理参数，这些参数已可预测住院患者的疾病轨迹。
本方案概述了一项针对 COVID-19 阳性患者 PASC 的前瞻性、纵向、观察性研究的设计和程序，旨在确定与 PASC 相关的可穿戴设备收集的生理参数。
这是一项针对 550 名年龄在 18 至 65 岁之间的患者的单臂、前瞻性、观察性队列研究，这些患者拥有满足预定蓝牙版本和操作系统要求的智能手机或平板电脑，会讲英语，并提供由医疗保健专业人员在入组前 5 天内签发的 COVID-19 阳性检测证明。主要终点是长 COVID-19，定义为首次症状发作或阳性诊断后 3 周以上出现≥1 个症状。次要终点是慢性 COVID-19，定义为首次症状发作或阳性诊断后 12 周以上出现≥1 个症状。参与者必须愿意并能够同意参与研究，并在 6 个月内遵守研究程序。
第一名患者于 2021 年 10 月入组。预计发表研究结果的年份为 2025 年。
这是一项使用可穿戴设备收集生理参数和患者报告结果来研究 PASC 的完全去中心化研究。该研究将阐明非住院患者亚组中 PASC 的持续时间和症状表现，并展示可穿戴设备作为传染病人群水平监测健康工具的应用范例。
ClinicalTrials.gov NCT04927442；https://clinicaltrials.gov/study/NCT04927442。
国际注册报告标识符（IRRID）：DERR1-10.2196/57382。
