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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337489
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : February 24, 2022
Sponsor:
Collaborator:
CW+ Charity
Information provided by (Responsible Party):
Imperial College London

Study Description
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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.

Condition or disease Intervention/treatment
Coronavirus Device: SensiumVitals wearable sensor

Study Design
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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: REmote MOniToring usE in Suspected Cases of COVID-19 (Coronavirus): REMOTE-COVID Trial
Actual Study Start Date : July 28, 2020
Actual Primary Completion Date : March 26, 2021
Actual Study Completion Date : March 26, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: SensiumVitals wearable sensor
    A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously.

Outcome Measures
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Primary Outcome Measures :
  1. Deterioration resulting in healthcare review [ Time Frame: 1 year ]
    Detection of clinical deterioration using wearable sensors resulting in healthcare review (e.g. GP telephone consultation)


Secondary Outcome Measures :
  1. Hospitalisation [ Time Frame: 1 year ]
    Deterioration resulting in hospitalisation

  2. Participant anxiety [ Time Frame: 1 year ]
    General Anxiety Disorder (GAD-7) questionnaire (responses noted on Likert scales); min score 0 and max score 21. Higher score associated with greater anxiety

  3. Participant depression [ Time Frame: 1 year ]
    Patient Health Questionnaire (PHQ-9) questionnaire (responses noted on Likert scales); min score 0 and max score 27. Higher score associated with greater depression.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337489


Locations
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United Kingdom
Imperial College London
London, United Kingdom
Sponsors and Collaborators
Imperial College London
CW+ Charity
Investigators
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Principal Investigator: Ara Darzi, Prof Institute of Global Health Innovation
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04337489    
Other Study ID Numbers: REMOTE-COVID
First Posted: April 7, 2020    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Imperial College London:
coronavirus
remote monitoring
deterioration
escalation
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Infections