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

NCT04335097 | Completed

• 1 other identifier: 127157
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID 19

Keywords

symptoms; biosensors; home isolation; NEWS; Outcome

Outcome Measures

Primary Outcomes (2)

• Stop home isolation

  Day during home isolation it was stopped due to hospitalization

  1 to 21 days

• NEWS score

  5 or \>3 for one organ system

  1 to 21 days

Secondary Outcomes (4)

• Clinic at hospitalization

  At admittance hospital

• Symptoms developed

  Duration of home isolation

• Relative/peers evaluation of the patient

  Duration of home isolation

• Serious of symptoms at admittance hospital

  Hospital stay

Study Arms (2)

Control

ACTIVE COMPARATOR

Follow general recommendations fram doctor and health authorities what to do and pay attention to before new contact with health service.

Device: Biosensors

Intervention

ACTIVE COMPARATOR

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

Interventions

Biosensors DEVICE

Sensor that detect vital signs

Also known as: Self reporting status

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Ti legally give consent
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lars Wik: lead
• University of Stavanger: collaborator
• Oslo University Hospital: collaborator
• Norwegian Telemedicine: collaborator
• University of the Basque Country (UPV/EHU): collaborator

Study Sites (1)

Lillestrom legevakt

Lillestrøm, Norway

Location

Related Publications (7)

• Bodapati RK, Kizer JR, Kop WJ, Kamel H, Stein PK. Addition of 24-Hour Heart Rate Variability Parameters to the Cardiovascular Health Study Stroke Risk Score and Prediction of Incident Stroke: The Cardiovascular Health Study. J Am Heart Assoc. 2017 Jul 21;6(7):e004305. doi: 10.1161/JAHA.116.004305.

  PMID: 28733431 BACKGROUND

• Seamless Healthcare Monitoring Advancements in Wearable, Attachable, and Invisible Devices. Chapter 5 Ballistocardiography.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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/

  BACKGROUND

• Samsudin MI, Liu N, Prabhakar SM, Chong SL, Kit Lye W, Koh ZX, Guo D, Rajesh R, Ho AFW, Ong MEH. A novel heart rate variability based risk prediction model for septic patients presenting to the emergency department. Medicine (Baltimore). 2018 Jun;97(23):e10866. doi: 10.1097/MD.0000000000010866.

  PMID: 29879021 RESULT

• Melillo P, Izzo R, Orrico A, Scala P, Attanasio M, Mirra M, De Luca N, Pecchia L. Automatic prediction of cardiovascular and cerebrovascular events using heart rate variability analysis. PLoS One. 2015 Mar 20;10(3):e0118504. doi: 10.1371/journal.pone.0118504. eCollection 2015.

  PMID: 25793605 RESULT

Related Links

• World Health Organization (WHO) recommendation
• Folke Helse Instituttet (FHI) recommendations
• WHO
• Omsyn Welfare Technology
• E Health

MeSH Terms

Conditions

COVID-19

Interventions

Biosensing Techniques

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Probe Techniques; Investigative Techniques

Study Officials

• Lars Wik, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Sensor monitoring can not be masked since it is the prerequisite for the measures.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Anesthesiology, senior researcher

Model Details: Two groups, control and intervention.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: April 22, 2020
• Primary Completion: April 8, 2022
• Study Completion: September 20, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)