WAVE. Wearable-based COVID-19 Markers for Prediction of Clinical Trajectories

NCT ID: NCT04357834

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-22

Study Completion Date

2021-06-30

Brief Summary

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The aim is to develop a wearable-based ICU (intensive care unit) prediction algorithm for inpatients contracted with SARS-CoV-2. Inpatients with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participants will be equipped with a smartwatch, which gathers physiological data throughout hospitalisation.

Detailed Description

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The SARS-CoV-2 pandemic puts an unprecedented burden on the healthcare system, specifically its healthcare providers and the resource demands for intensive care units (ICUs). To support effective care despite large case numbers, hospital operations urgently need improved decision support in early identification of patients at risk of an acute COVID-19 deterioration that requires ICU.

The investigators aim at developing a wearable-based ICU algorithm for inpatients contracted with SARS-CoV-2. Inpatients on the general ward with suspicion of COVID-19 or with confirmed SARS-CoV-2 infection will be included. The participant will be equipped with a smartwatch and wear the device throughout the hospital stay until the patient (1) is discharged home, (2) is transferred to the ICU, or (3) palliative care is initiated. The smartwatch collects several physiological parameters (e.g. heart rate, heart rate variability, respiration rate, oxygen saturation). The collected data will be used to develop an ICU prediction algorithm to detect patients at risk of an acute COVID-19 deterioration that requires ICU.

Conditions

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COVID COVID 19 SARS-CoV 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Smartwatch group

Equipment with smartwatch throughout hospital stay on the general ward

Intervention Type OTHER

Participants with confirmed SARS-CoV-2 infection or suspicion of COVID-19 will be equipped with a smartwatch and wear the device throughout the hospital stay on the general ward.

Interventions

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Equipment with smartwatch throughout hospital stay on the general ward

Participants with confirmed SARS-CoV-2 infection or suspicion of COVID-19 will be equipped with a smartwatch and wear the device throughout the hospital stay on the general ward.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent as documented by signature
* Age \>= 18 years
* Suspicion of COVID-19 or patient tested positive for SARS-CoV-2
* Hospitalisation on the general ward

Exclusion Criteria

* Smartwatch cannot be attached around the wrist of the patient
* Direct transfer from the emergency department or external institution to ICU (i.e. no hospitalization on the general ward)
* Known allergies to components of the smartwatch
* Rejection of ICU transfer in the patient decree
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ETH Zurich

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aristomenis Extradaktylos, Prof. MD

Role: STUDY_CHAIR

University Hospital Bern - Department of Emergency Medicine

Locations

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Emergency Department, University Hospital Bern, Inselspital

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Foll S, Lison A, Maritsch M, Klingberg K, Lehmann V, Zuger T, Srivastava D, Jegerlehner S, Feuerriegel S, Fleisch E, Exadaktylos A, Wortmann F. A Scalable Risk-Scoring System Based on Consumer-Grade Wearables for Inpatients With COVID-19: Statistical Analysis and Model Development. JMIR Form Res. 2022 Jun 21;6(6):e35717. doi: 10.2196/35717.

Reference Type DERIVED
PMID: 35613417 (View on PubMed)

Other Identifiers

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WAVE

Identifier Type: -

Identifier Source: org_study_id

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