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

NCT05959928 | Completed

• 1 other identifier: 859/20/EC
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• Evaluate the safety, usability and comfort of Viture Device

  Through study completion, an average of 5 days

Study Arms (1)

Hospital at Home patients

Device: Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely

Interventions

Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely DEVICE

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)

Hospital at Home patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vitio Medical S.L.: lead
• Hospital of Navarra: collaborator
• NavarraBiomed Biomedical Research Center: collaborator

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

COVID-19; Communicable Diseases; Urinary Tract Infections; Bacteremia; Respiratory Tract Infections; Cellulitis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Maria Ruiz Castellano, MD

  Hospital of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 25, 2023
• Study Start: February 9, 2021
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)