Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus)

NCT04337489 | Completed Results FDA Device

• 1 other identifier: REMOTE-COVID
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.

Conditions

Coronavirus

Keywords

coronavirus; remote monitoring; deterioration; escalation

Outcome Measures

Primary Outcomes (1)

• Deterioration Resulting in Healthcare Review

  Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation)

  1 year

Secondary Outcomes (1)

• Hospitalisation

  1 year

Interventions

SensiumVitals wearable sensor DEVICE

A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Returning traveller from a high-risk area into a London airport. * Have mild symptoms indicative of Covid-19 * Unable to self-isolate

You may qualify if:

• Aged 18 years or over.
• Able to provide written consent.

You may not qualify if:

• Any participants that withdraw their consent.
• A skin condition/reaction preventing wearing the wearable sensor.
• The presence of a permanent pacemaker or cardiac defibrillator.
• Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
• Inability to cooperate or communicate with the research team.

Sponsors & Collaborators

• Imperial College London: lead
• CW+ Charity: collaborator

Study Sites (1)

Imperial College London

London, United Kingdom

Location

Related Publications (2)

• Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2). BMC Public Health. 2021 Apr 1;21(1):638. doi: 10.1186/s12889-021-10660-9.

  PMID: 33794832 RESULT

• Iqbal FM, Joshi M, Davies G, Khan S, Ashrafian H, Darzi A. Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2). Pilot Feasibility Stud. 2021 Mar 5;7(1):62. doi: 10.1186/s40814-021-00804-4.

  PMID: 33673868 DERIVED

Related Links

• Trial Protocol
• Published article

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Fahad Iqbal
• Organization: Imperial College London

f.iqbal@imperial.ac.uk

020 3312 6666

Study Officials

• Ara Darzi, Prof

  Institute of Global Health Innovation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 7, 2020
• Study Start: July 28, 2020
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Locations

GB (1)