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Continuous Temperature Telemonitoring of Patients With COVID-19 and Other Infectious Diseases in Hospital at Home Using Viture (Viture)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05959928
Recruitment Status : Completed
First Posted : July 25, 2023
Last Update Posted : July 27, 2023
Sponsor:
Collaborators:
Hospital Universitario de Navarra
NAVARRABIOMED
Information provided by (Responsible Party):
Vitio Medical S.L.

Study Description
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Brief Summary:
The aim of this cohort study is to validate Viture®, a continuous temperature telemonitoring system, evaluating the level of agreement with a standard commercially available digital axillary thermometer. The study also aims to evaluate the safety and comfort of the system and to evaluate the impact that the introduction of Viture has on the health care practice of a HaH unit. Furthermore, the advantages of Viture compared to the standard method will be evaluated.

Condition or disease Intervention/treatment
COVID-19 Infectious Disease Tract Infection, Urinary Bacteremia Respiratory Infection Cellulitis Device: Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely

Detailed Description:

Body temperature is a key vital sign in the follow-up of patients admitted to Hospital at Home (HaH) units with COVID-19 and other infectious diseases. Continuous telemonitoring of temperature can lead to earlier detection of fever and patient deterioration that facilitates early decision making.

In the first day of the study, the patients will be given a study kit of Viture System with the following content:

  • Viture Device.
  • Digital reference thermometer for control Spot Temperature Measurements (STMs)
  • Smartphone with Viture Mobile App installed.
  • Device user manual in quick guide format.
  • Home data collection notebook (HDCN)

The HaH team will place Viture Device on the patient and train the patient and/or caregiver. They will ask patients to complete control STMs between 3 and 6 times a day on the same arm where the Viture Device is placed and record the measuring data in the HDCN.

In the case that the bracelet is removed, or the patient experience discomfort, they will be asked to fill in the incident in the HDCN. Mild incidents are considered skin alterations such as redness and chafing and severe incidents are considered hematomas and ulcers.

The HaH team on duty will collect all Viture notifications, registering the date, time, and follow-up for each febrile episode. The patient and/or caregiver could be contacted to request a control STM.

A statistical analysis of agreement between the digital reference thermometer (Gold standard) and Viture will be carried out. The non-parametric Wilcoxon signed rank test will be used to evaluate the average agreement between the two methods, and the Bland Altman method will be used to evaluate the agreement between individual measurements. Both analyses will be validated with a 95% confidence interval.

To explore the true potential of Viture, an analysis of the febrile episodes experienced by patients during the clinical study will be performed. Febrile episodes will be characterized by their maximum temperature and duration. To assess the impact of Viture notifications, the data registered on the follow-up of febrile episodes will be analyzed.

Study Design
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Study Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temperature Telemonitoring for Hospital at Home (HaH) Patients
Actual Study Start Date : February 9, 2021
Actual Primary Completion Date : June 2, 2021
Actual Study Completion Date : June 2, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Hospital at Home patients Device: Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely
The HaH team will place Viture Device on the patient's armpit and train the patient and/or caregiver. They will ask to complete control STMs between 3 and 6 times a day on the same arm where the Viture Device is placed and record the measuring data in the Home data collection notebook (HDCN)


Outcome Measures
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Primary Outcome Measures :
  1. Verify that, under normal conditions of use, the performance of Viture for body temperature measurement is equivalent to the devices used in the standard practice. [ Time Frame: 3 measurements per day ]
    Comparison between the temperatures recorded remotely by Viture and a control digital thermometer used in the follow-up of patients in Hospital at Home, both COVID-19 patients and patients with other diseases who benefit from body temperature monitoring.


Secondary Outcome Measures :
  1. Evaluate the safety, usability and comfort of Viture Device [ Time Frame: Through study completion, an average of 5 days ]
    Record usability experience and negative sensations expressed by users due to the use of Viture, such as discomfort or skin irritation in the area where the device is placed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients older than 18 years old who have been admitted to Hospital at Home (HaH) units with COVID-19 and other infectious diseases.
Criteria

Inclusion Criteria:

  • be more than 18 years old.
  • to be able to legally give informed consent.
  • not to have limitations to the use of the Viture Device due to their physical conditions or interference with other devices.

Exclusion Criteria:

  • To be monitored for less than 2 days.
  • To have less than 4 valid control Spot Temperature Measurements (STM). A valid control STM is considered a temperature measured with the reference thermometer that has a simultaneous (within 1 minute) Viture Temperature Measurement (VTM)
Contacts and Locations
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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): NCT05959928


Locations
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Spain
Hospital Universitario de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Vitio Medical S.L.
Hospital Universitario de Navarra
NAVARRABIOMED
Investigators
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Principal Investigator: Maria Ruiz Castellano, MD Hospital Universitario de Navarra
More Information
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Responsible Party: Vitio Medical S.L.
ClinicalTrials.gov Identifier: NCT05959928    
Other Study ID Numbers: 859/20/EC
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023
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 Vitio Medical S.L.:
Continuous body temperature monitoring
Hospital at Home
Telemonitoring
Remote Patient Monitoring
Virtual wards
Fever detection
 Infectious diseases
Telemedicine
Telehealth
COVID-19
Real-time data
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Bacteremia
Cellulitis
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Skin Diseases, Infectious
Suppuration
Connective Tissue Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases