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

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT04337489
Collaborator
CW+ Charity (Other)
14
1
7.9
1.8

Study Details

Study Description

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 Phase
  • Device: SensiumVitals wearable sensor

Study Design

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 :
Jul 28, 2020
Actual Primary Completion Date :
Mar 26, 2021
Actual Study Completion Date :
Mar 26, 2021

Outcome Measures

Primary Outcome Measures

  1. Deterioration resulting in healthcare review [1 year]

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

Secondary Outcome Measures

  1. Hospitalisation [1 year]

    Deterioration resulting in hospitalisation

  2. Participant anxiety [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 [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

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Imperial College London London United Kingdom

Sponsors and Collaborators

  • Imperial College London
  • CW+ Charity

Investigators

  • Principal Investigator: Ara Darzi, Prof, Institute of Global Health Innovation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT04337489
Other Study ID Numbers:
  • REMOTE-COVID
First Posted:
Apr 7, 2020
Last Update Posted:
Feb 24, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Imperial College London
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 24, 2022