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Sensor Based Vital Signs Monitoring of Covid 19 Patients During Home Isolation (HSC19)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335097
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborators:
University of Stavanger
Oslo University Hospital
Norwegian Telemedicine
University of Basque Country (UPV/EHU)
Information provided by (Responsible Party):
Lars Wik, Ullevaal University Hospital

Brief Summary:

Severe acute respiratory syndrome (SARS) SARS-Cov-2 disease (COVID-19) is an infectious disease caused by a coronavirus. The pandemic first described in Wuhan, China, has since spread across the whole world and caused dramatic strain on health care in many countries. Patients infected with the virus mostly report mild to moderate respiratory symptoms like shortness of breath and coughing, and febrile symptoms. It is of paramount importance to preserve health service capacity by identifying those with serious illness without transferring all infected patients to emergency rooms or Hospitals. In addition, it is important to identify seriously ill patients early enough and before they reach a point of deterioration where they can be extremely challenging to handle in both prehospital and hospital environment.

The present study is designed to sample biosensor data from patients treated and observed at home due to mild and moderate SARS-Cov-2 disease. Such a system would be useful, both for the treatment of individual patients as well as for assessing the efficacy and safety of care given to these patients. Investigators intend to improve quality and safety of home care by continuous monitoring and a set of rules for follow-up.

Investigators hypothesized that patients and local health system may benefit from the feedback of a simple monitoring system, which detects changes in respiration, temperature and circulation variables in combination with the patient's subjective experiences of care. Patients may be referred to hospitalization earlier. In the present study we will use live continuous and non-continuous biosensor data to monitor the development of vital parameters for Covid 19 patients compared with patients who are not monitored electronically (standard of care).


Condition or disease Intervention/treatment Phase
COVID 19 Device: Biosensors Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups, control and intervention.
Masking: None (Open Label)
Masking Description: Sensor monitoring can not be masked since it is the prerequisite for the measures.
Primary Purpose: Supportive Care
Official Title: Sensor Based Vital Signs Monitoring of Patients With Clinical Manifestation of Covid 19 Disease During Home Isolation, a Randomized Feasibility Study
Actual Study Start Date : April 22, 2020
Estimated Primary Completion Date : April 8, 2021
Estimated Study Completion Date : December 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Arm Intervention/treatment
Active Comparator: Control
Follow general recommendations fram doctor and health authorities what to do and pay attention to before new contact with health service.
Device: Biosensors
Sensor that detect vital signs
Other Name: Self reporting status

Active Comparator: Intervention
Follow general recommendations fram doctor and health authorities what to do and pay attention to before new contact with health service. I addition active reporting of clinical status and continuous vital sign monitoring based on electronic sensors (Welfare technology).
Device: Biosensors
Sensor that detect vital signs
Other Name: Self reporting status




Primary Outcome Measures :
  1. Stop home isolation [ Time Frame: 1 to 21 days ]
    Day during home isolation it was stopped due to hospitalization

  2. NEWS score [ Time Frame: 1 to 21 days ]
    5 or >3 for one organ system


Secondary Outcome Measures :
  1. Clinic at hospitalization [ Time Frame: At admittance hospital ]
    Relevant vital clinical findings

  2. Symptoms developed [ Time Frame: Duration of home isolation ]
    Symptoms developed during home isolation

  3. Relative/peers evaluation of the patient [ Time Frame: Duration of home isolation ]
    Their description of vital sign development

  4. Serious of symptoms at admittance hospital [ Time Frame: Hospital stay ]
    Referred to ICU, intubated, length of stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Ti legally give consent
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Valid informed consent.
  • All Covid 19 positive patients age ≥18 years who are under care at home for Covid 19 infection.
  • Patients with typical Covid 19 clinical symptoms where a test has not been taken may also be included if a test later is positive.
  • Able to log into internet.

Exclusion Criteria:

  • Age <18 years.
  • Covid 19 negative.
  • Internals in prison.
  • Individuals living in special homes due to need of care.
  • Refusal of participation.
  • Comorbidity that hinder the patient to run the system.

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): NCT04335097


Contacts
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Contact: Lars Wik, MD 91728966 lars.wik@medisin.uio.no

Locations
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Norway
Lillestrom legevakt Recruiting
Lillestrom, Norway
Contact: Tonje Lorem         
Sponsors and Collaborators
Lars Wik
University of Stavanger
Oslo University Hospital
Norwegian Telemedicine
University of Basque Country (UPV/EHU)
Investigators
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Principal Investigator: Lars Wik, MD Oslo University Hospital
Additional Information:
Publications of Results:
Other Publications:
Seamless Healthcare Monitoring Advancements in Wearable, Attachable, and Invisible Devices. Chapter 5 Ballistocardiography.
The Royal College of Physicians. National Early Warning Score (NEWS) 2: Standardising the assessment of acute-illness severity in the NHS. London: RCP; 2017. p. 1-77.
Williams B, Alberti G, Ball C, et al; Royal College for Physicians: National Early Warning Score (NEWS): Standardising the Assessment of Acute-Illness Severity in the NHS. 2012London, ENG, Royal College of Physicians.
Meld. St. 16 (2010-2011) Report to the Storting (white paper) Summary - National Health and Care Services Plan. https://www.regjeringen.no/en/dokumenter/meld.-st.-16-2010-2011/id639794/

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Responsible Party: Lars Wik, Consultant in Anesthesiology, senior researcher, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT04335097    
Other Study ID Numbers: 127157
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lars Wik, Ullevaal University Hospital:
symptoms
biosensors
home isolation
NEWS
Outcome