Feasibility of wearable sensor signals and self-reported symptoms to prompt at-home testing for acute respiratory viruses in the USA (DETECT-AHEAD): a decentralised, randomised controlled trial.

Autor:	Quer G; Scripps Research Translational Institute, La Jolla, CA, USA. Electronic address: gquer@scripps.edu., Coughlin E; Scripps Research Translational Institute, La Jolla, CA, USA., Villacian J; Janssen Pharmaceutical Research and Development, San Diego, CA, USA., Delgado F; Scripps Research Translational Institute, La Jolla, CA, USA., Harris K; Janssen Pharmaceutical Research and Development, San Diego, CA, USA., Verrant J; Janssen Pharmaceutical Research and Development, San Diego, CA, USA., Gadaleta M; Scripps Research Translational Institute, La Jolla, CA, USA., Hung TY; Scripps Research Translational Institute, La Jolla, CA, USA., Ter Meer J; Scripps Research Translational Institute, La Jolla, CA, USA., Radin JM; Scripps Research Translational Institute, La Jolla, CA, USA., Ramos E; Scripps Research Translational Institute, La Jolla, CA, USA., Adams M; Janssen Pharmaceutical Research and Development, San Diego, CA, USA., Kim L; Janssen Pharmaceutical Research and Development, San Diego, CA, USA., Chien JW; Janssen Pharmaceutical Research and Development, San Diego, CA, USA., Baca-Motes K; Scripps Research Translational Institute, La Jolla, CA, USA., Pandit JA; Scripps Research Translational Institute, La Jolla, CA, USA., Talantov D; Janssen Pharmaceutical Research and Development, San Diego, CA, USA., Steinhubl SR; Scripps Research Translational Institute, La Jolla, CA, USA.
Jazyk:	angličtina
Zdroj:	The Lancet. Digital health [Lancet Digit Health] 2024 Aug; Vol. 6 (8), pp. e546-e554.
DOI:	10.1016/S2589-7500(24)00096-7
Abstrakt:	Background: Early identification of an acute respiratory infection is important for reducing transmission and enabling earlier therapeutic intervention. We aimed to prospectively evaluate the feasibility of home-based diagnostic self-testing of viral pathogens in individuals prompted to do so on the basis of self-reported symptoms or individual changes in physiological parameters detected via a wearable sensor. Methods: DETECT-AHEAD was a prospective, decentralised, randomised controlled trial carried out in a subpopulation of an existing cohort (DETECT) of individuals enrolled in a digital-only observational study in the USA. Participants aged 18 years or older were randomly assigned (1:1:1) with a block randomisation scheme stratified by under-represented in biomedical research status. All participants were offered a wearable sensor (Fitbit Sense smartwatch). Participants in groups 1 and 2 received an at-home self-test kit (Alveo be.well) for two acute respiratory viral pathogens: SARS-CoV-2 and respiratory syncytial virus. Participants in group 1 could be alerted through the DETECT study app to take the at-home test on the basis of changes in their physiological data (as detected by our algorithm) or due to self-reported symptoms; those in group 2 were prompted via the app to self-test only due to symptoms. Group 3 served as the control group, without alerts or home testing capability. The primary endpoints, assessed on an intention-to-treat basis, were the number of acute respiratory infections presented (self-reported) and diagnosed (electronic health record), and the number of participants using at-home testing in groups 1 and 2. This trial is registered with ClinicalTrials.gov, NCT04336020. Findings: Between Sept 28 and Dec 30, 2021, 450 participants were recruited and randomly assigned to group 1 (n=149), group 2 (n=151), or group 3 (n=150). 179 (40%) participants were male, 264 (59%) were female, and seven (2%) identified as other. 232 (52%) were from populations historically under-represented in biomedical research. 118 (39%) of the 300 participants in groups 1 and 2 were prompted to self-test, with 61 (52%) successfully completing self-testing. Participants were prompted to home-test more frequently due to symptoms (41 [28%] in group 1 and 51 [34%] in group 2) than due to detected physiological changes (26 [17%] in group 1). Significantly more participants in group 1 received alerts to test than did those in group 2 (67 [45%] vs 51 [34%]; p=0·047). Of the 61 individuals who were prompted to test and successfully did so, 19 (31%) tested positive for a viral pathogen-all for SARS-CoV-2. The individuals diagnosed as positive for SARS-CoV-2 in the electronic health record were eight (5%) in group 1, four (3%) in group 2, and two (1%) in group 3, but it was difficult to confirm if they were tied to symptomatic episodes documented in the trial. There were no adverse events. Interpretation: In this direct-to-participant trial, we showed early feasibility of a decentralised programme to prompt individuals to use a viral pathogen diagnostic test based on symptoms tracked in the study app or physiological changes detected using a wearable sensor. Barriers to adequate participation and performance were also identified, which would need to be addressed before large-scale implementation. Funding: Janssen Pharmaceuticals. Competing Interests: Declaration of interests JVi, KH, JVe, MA, LK, JWC, and DT are employed by Janssen Pharmaceuticals. JMR was supported by The Rockefeller Foundation and is now employed by Moderna. ER is employed by CareEvolution. KB-M is a consultant for CareEvolution and was on the Heartline Study Executive Committee. SRS is a consultant for PhysIQ and declares payment for being on the Heartline Study Executive Committee. All other authors declare no competing interests. (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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