Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus) (REMOTE-COVID)
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|ClinicalTrials.gov Identifier: NCT04337489|
Recruitment Status : Completed
First Posted : April 7, 2020
Last Update Posted : February 24, 2022
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|Condition or disease||Intervention/treatment|
|Coronavirus||Device: SensiumVitals wearable sensor|
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|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|
- Device: SensiumVitals wearable sensor
A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously.
- 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)
- Hospitalisation [ Time Frame: 1 year ]Deterioration resulting in hospitalisation
- 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
- 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.
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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|
- Returning traveller from a high-risk area into a London airport.
- Have mild symptoms indicative of Covid-19
- Unable to self-isolate
- Aged 18 years or over.
- Able to provide written consent.
- 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.
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
|Imperial College London|
|London, United Kingdom|
|Principal Investigator:||Ara Darzi, Prof||Institute of Global Health Innovation|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Imperial College London|
|Other Study ID Numbers:||
|First Posted:||April 7, 2020 Key Record Dates|
|Last Update Posted:||February 24, 2022|
|Last Verified:||February 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
RNA Virus Infections