Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 15, 2024
Date Accepted: Jun 14, 2024
A prospective natural history study of post-acute sequelae of COVID-19 using digital wearables: Study protocol
ABSTRACT
Background:
Post-acute sequelae of COVID-19 (PASC) remains 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.
Objective:
This protocol outlines the design and procedures of a natural history study of PASC that aims to identify wearables collected physiological parameters that are associated with PASC in patients with a positive diagnosis.
Methods:
This is a single-arm, prospective, natural history study of a cohort of 550 patients, ages 18 to 65 years old, males or females who own a smartphone and/or a tablet that meets pre-determined Bluetooth version and operating system requirements, speak English, and provide documentation of a positive COVID-19 test issued by a healthcare professional within 5 days before enrollment. The primary endpoint is long COVID-19, defined as ≥1 symptom at 3 weeks beyond first symptom onset or positive diagnosis, whichever comes first. The secondary endpoint is chronic COVID-19, defined as ≥1 symptom at 12 weeks beyond 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 six months.
Results:
The first patient was enrolled in October 2021.
Conclusions:
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 use of wearables as population-level monitoring health tools for communicable diseases. Clinical Trial: ClinicalTrials.gov NCT04927442
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