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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.

Tracking Information
First Submitted Date July 20, 2023
First Posted Date July 25, 2023
Last Update Posted Date July 27, 2023
Actual Study Start Date February 9, 2021
Actual Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 24, 2023)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 24, 2023)		 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • COVID-19
  • Infectious Disease
  • Tract Infection, Urinary
  • Bacteremia
  • Respiratory Infection
  • Cellulitis
Intervention 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)
Study Groups/Cohorts Hospital at Home patients
Intervention: Device: Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 24, 2023)		 209
Original Actual Enrollment Same as current
Actual Study Completion Date June 2, 2021
Actual Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT05959928
Other Study ID Numbers 859/20/EC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Vitio Medical S.L.
Original Responsible Party Same as current
Current Study Sponsor Vitio Medical S.L.
Original Study Sponsor Same as current
Collaborators
  • Hospital Universitario de Navarra
  • NAVARRABIOMED
Investigators
Principal Investigator: Maria Ruiz Castellano, MD Hospital Universitario de Navarra
PRS Account Vitio Medical S.L.
Verification Date July 2023