Literature DB >> 33673868

Design of the pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV-2).

Fahad Mujtaba Iqbal1, Meera Joshi2, Gary Davies3, Sadia Khan3, Hutan Ashrafian2, Ara Darzi2.   

Abstract

BACKGROUND: The outbreak of SARS-CoV-2 (coronavirus, COVID-19), declared a pandemic by the World Health Organization (WHO), is a global health problem with ever-increasing attributed deaths. Vital sign trends are routinely used to monitor patients with changes in these parameters often preceding an adverse event. Wearable sensors can measure vital signs continuously (e.g. heart rate, respiratory rate, temperature) remotely and can be utilised to recognise early clinical deterioration.
METHODS: We describe the protocol for a pilot, proof-of-concept, observational study to be conducted in an engineered hotel near London airports, UK. The study is set to continue for the duration of the pandemic. Individuals arriving to London with mild symptoms suggestive of COVID-19 or returning from high-risk areas requiring quarantine, as recommended by the Public Health England, or healthcare professionals with symptoms suggestive of COVID-19 unable to isolate at home will be eligible for a wearable patch to be applied for the duration of their stay. Notifications will be generated should deterioration be detected through the sensor and displayed on a central monitoring hub viewed by nursing staff, allowing for trend deterioration to be noted. The primary objective is to determine the feasibility of remote monitoring systems in detecting clinical deterioration for quarantined individuals in a hotel. DISCUSSION: This trial should prove the feasibility of a rapidly implemented model of healthcare delivery through remote monitoring during a global pandemic at a hotel, acting as an extension to a healthcare trust. Potential benefits would include reducing infection risk of COVID-19 to healthcare staff, with earlier recognition of clinical deterioration through ambulatory, continuous, remote monitoring using a discrete wearable sensor. We hope our results can power future, robust randomised trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04337489 .

Entities:  

Keywords:  Ambulatory; Clinical trial; Monitoring; Patient deterioration; Protocol; Remote-sensing technology

Year:  2021        PMID: 33673868     DOI: 10.1186/s40814-021-00804-4

Source DB:  PubMed          Journal:  Pilot Feasibility Stud        ISSN: 2055-5784


  5 in total

1.  A brief measure for assessing generalized anxiety disorder: the GAD-7.

Authors:  Robert L Spitzer; Kurt Kroenke; Janet B W Williams; Bernd Löwe
Journal:  Arch Intern Med       Date:  2006-05-22

2.  SPIRIT 2013 statement: defining standard protocol items for clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Douglas G Altman; Andreas Laupacis; Peter C Gøtzsche; Karmela Krleža-Jerić; Asbjørn Hróbjartsson; Howard Mann; Kay Dickersin; Jesse A Berlin; Caroline J Doré; Wendy R Parulekar; William S M Summerskill; Trish Groves; Kenneth F Schulz; Harold C Sox; Frank W Rockhold; Drummond Rennie; David Moher
Journal:  Ann Intern Med       Date:  2013-02-05       Impact factor: 25.391

3.  Reliability of a wearable wireless patch for continuous remote monitoring of vital signs in patients recovering from major surgery: a clinical validation study from the TRaCINg trial.

Authors:  Candice Downey; Shu Ng; David Jayne; David Wong
Journal:  BMJ Open       Date:  2019-08-15       Impact factor: 2.692

4.  A tutorial on pilot studies: the what, why and how.

Authors:  Lehana Thabane; Jinhui Ma; Rong Chu; Ji Cheng; Afisi Ismaila; Lorena P Rios; Reid Robson; Marroon Thabane; Lora Giangregorio; Charles H Goldsmith
Journal:  BMC Med Res Methodol       Date:  2010-01-06       Impact factor: 4.615

5.  Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.

Authors:  Mariska Weenk; Sebastian J Bredie; Mats Koeneman; Gijs Hesselink; Harry van Goor; Tom H van de Belt
Journal:  J Med Internet Res       Date:  2020-06-10       Impact factor: 5.428

  5 in total
  3 in total

1.  Assessing the safety of home oximetry for COVID-19: a multisite retrospective observational study.

Authors:  Jonathan Clarke; Kelsey Flott; Roberto Fernandez Crespo; Hutan Ashrafian; Gianluca Fontana; Jonathan Benger; Ara Darzi; Sarah Elkin
Journal:  BMJ Open       Date:  2021-09-14       Impact factor: 3.006

2.  The pilot, proof of concept REMOTE-COVID trial: remote monitoring use in suspected cases of COVID-19 (SARS-CoV 2).

Authors:  Fahad Mujtaba Iqbal; Meera Joshi; Gary Davies; Sadia Khan; Hutan Ashrafian; Ara Darzi
Journal:  BMC Public Health       Date:  2021-04-01       Impact factor: 3.295

3.  Characteristics and predictors of acute and chronic post-COVID syndrome: A systematic review and meta-analysis.

Authors:  Fahad M Iqbal; Kyle Lam; Viknesh Sounderajah; Jonathan M Clarke; Hutan Ashrafian; Ara Darzi
Journal:  EClinicalMedicine       Date:  2021-05-24
  3 in total

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