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

July 25, 2023 updated by: Vitio Medical S.L.

Temperature Telemonitoring for Hospital at Home (HaH) Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital Universitario de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 measurements per day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitio Medical S.L.

Collaborators

Hospital Universitario de Navarra
NAVARRABIOMED

Investigators

  • Principal Investigator: Maria Ruiz Castellano, MD, Hospital Universitario de Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Actual)

June 2, 2021

Study Completion (Actual)

June 2, 2021

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 859/20/EC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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