COVID-19VitureNCT05959928
Continuous Temperature Telemonitoring of Patients With COVID-19 and Other Infectious Diseases in Hospital at Home Using Viture
An observational study of COVID-19 and Infectious Disease, run by Vitio Medical S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Infectious Disease, Tract Infection, Urinary
- What is being tested?
- Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely
- Type of treatment
- Medical device
- How many people
- 208 participants
- Where
- 1 siteSpain
- Study dates
- 9 Feb 2021to 2 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Infectious Disease, Tract Infection, Urinary, Bacteremia, Respiratory Infection, Cellulitis
- Being tested
- Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely
- 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
- Medical subject headings
- COVID-19, Communicable Diseases, Urinary Tract Infections, Bacteremia, Respiratory Tract Infections, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotelyDevice
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 group | Role | What they receive |
|---|---|---|
| Hospital at Home patients | Not described Receives: Device: Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 measurements per day
Secondary outcomes (1)
Evaluate the safety, usability and comfort of Viture Device
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.
Measured: Through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start9 Feb 2021
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitio Medical S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital of Navarra, NavarraBiomed Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Maria Ruiz Castellano, MD, Principal investigator, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959928
- Sponsor's protocol ID
- 859/20/EC
- Acronym
- Viture
- Status last verified
- Jul 2024
- First submitted
- 20 Jul 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Telemonitoring for Hospital at Home (HaH) Patients
- ClinicalTrials.gov ID
- NCT05959928
- Acronym / sponsor ID
- Viture / 859/20/EC
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Vitio Medical S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital of Navarra, NavarraBiomed Biomedical Research Center
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital at Home patients | – | Device: Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotely |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous wearable thermometer placed on patient's armpit to monitor body temperature remotelyThe 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) | Device | Hospital at Home patients |
Primary outcome
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.
1 secondary outcome
Evaluate the safety, usability and comfort of Viture Device
Time frame: Through study completion, an average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Ruiz Castellano, MD principal investigator
Hospital of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Infectious Disease, run by Vitio Medical S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 measurements per day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.