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

NCT04335097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2022-09-21

No results posted yet for this study

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).

Conditions

  • COVID 19

Interventions

DEVICE

Biosensors

Sensor that detect vital signs

Sponsors & Collaborators

  • University of Stavanger

    collaborator OTHER
  • Oslo University Hospital

    collaborator OTHER
  • Norwegian Telemedicine

    collaborator UNKNOWN
  • University of the Basque Country (UPV/EHU)

    collaborator OTHER
  • Lars Wik

    lead OTHER

Principal Investigators

  • Lars Wik, MD · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-22
Primary Completion
2022-04-08
Completion
2022-09-20

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335097 on ClinicalTrials.gov