Clinical trial NCT05959928: Continuous Temperature Telemonitoring of Patients With COVID-19 and Other Infectious Diseases in Hospital at Home Using Viture
Official title: Temperature Telemonitoring for Hospital at Home (HaH) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Infectious Disease
Tract Infection, Urinary
Bacteremia
Respiratory Infection
Cellulitis
Keywords: Continuous body temperature monitoring
Hospital at Home
Telemonitoring
Remote Patient Monitoring
Virtual wards
Fever detection
Infectious diseases
Telemedicine
Telehealth
COVID-19
Real-time data
Lead sponsor: Vitio Medical S.L.
Sponsor class: INDUSTRY
Collaborators: name: Hospital of Navarra
name: NavarraBiomed Biomedical Research Center
First posted: 2023-07-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: 3 measurements per day
Secondary outcomes:
measure: Evaluate the safety, usability and comfort of Viture Device
timeFrame: Through study completion, an average of 5 days
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
Study officials:
affiliation: Hospital of Navarra
name: Maria Ruiz Castellano, MD
role: PRINCIPAL_INVESTIGATOR
References: