Official Title
Sensor Based Vital Signs Monitoring of Patients With Clinical Manifestation of Covid 19 Disease During Home Isolation, a Randomized Feasibility Study
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).

Detailed Description

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.
The virus spreads primarily through droplets of saliva or discharge from the nose when an
infected person coughs or sneezes.1 Patients infected with the virus mostly report mild to
moderate respiratory symptoms like shortness of breath and coughing, and febrile symptoms.
Most recover without requiring special treatment. However, older people, and those with
underlying medical problems (cardiovascular disease, diabetes, chronic respiratory disease,
and cancer) are more likely to develop serious illness.1 Younger patients have been reported
with serious illness as well. In the present situation, 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 number of subjects with positive test of the virus is increasing and so does the number
of patients hospitalized.2 In parallel, most patients with positive test result or typical
clinical symptoms are at home with information what to do if their clinical symptom status
deteriorates.2 The Norwegian Interaction Reform was implemented in 2012.3 Key elements of the
reform are guidance of the health care in the future and identify new directions. Prevention
and early efforts are important and this will be achieved by creating co-working arenas for
different parts of our health system. More health services must be moved closer to where the
inhabitants live and simultaneously strengthening the community health system. New tools for
monitoring the well-being of the patients must be developed in order to act early enough to
avoid severe deterioration of health status and avoid new hospitalization. This goal has
become even more important during the Covid 19 pandemic because the healthcare system is not
prepared or built to take care of all these patients in hospitals.

In the local community's wearable and wireless biosensors collecting continuous physiological
data (CPD) in real time in order to generate information reflecting the patients' current
state is established. This is recognized as welfare technology, and it is a generic term for
a heterogeneous group of technologies.4 There are few studies documenting their efficacy,
effectiveness and efficiency. One key driver for the development of wearable biosensors is
the potential to use CPD to generate real-time, clinically actionable insights from
predictive analytics that include early warnings of clinical deterioration and prompts for
behavioral changes. The advent of machine learning methods that can detect subtle patterns
from large sets of CPD may make this achievable.

Using CPD to guide clinical decisions may be a major advance for patients with chronic
diseases and at present time when our health system is put on an extreme stretch. This may
drive the evolution from episodic to continuous patient care.

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 investigators 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).

Completed
COVID 19

Device: Biosensors

Sensor that detect vital signs
Other Name: Self reporting status

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Norway
Locations

Lillestrom legevakt
Lillestrom, Norway

Lars Wik, MD, Principal Investigator
Oslo University Hospital

NCT Number
Keywords
symptoms
biosensors
home isolation
NEWS
Outcome
MeSH Terms
COVID-19