COVID-19SOY+NCT04802018
Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients
A study testing Clinical decision support system based on non-invasive multimodal monitoring in people with COVID-19, run by Increase-Tech at 1 site in Spain.
Trial summary
The aim of the study is to provide clinical decision support to healthcare professionals using a wearable for non-invasive multimodal monitoring, allowing early detection of disease progression to severe forms, as well as the detection of significant clinical events. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Clinical decision support system based on non-invasive multimodal monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2021to 28 Dec 2022
- Phase
- Interventional
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of SARS-CoV-2 disease, detected by PCR or antigen test, performed 72 h prior to patient inclusion in the study.
- Acceptance to sign the informed consent document.
- Possession of a Smartphone or Tablet with Internet connection.
- Possession of mental faculties to participate in the study.
Who cannot join
- Age below the age of health majority (16 years).
- Lack of digital skills to use the Home App.
- Cognitive impairment that prevents the patient from participating in the study.
- Disabling pathology of the upper limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients With Domiciliary Follow-up
The aim of the study is to provide clinical decision support to healthcare professionals using a wearable for non-invasive multimodal monitoring, allowing early detection of disease progression to severe forms, as well as the detection of significant clinical events.
For the development of the study, 500 individuals with COVID-19 in home confinement will be randomly assigned to form part of the control group, which will be followed conventionally by Primary Care Professionals, or to the experimental group, which will also be provided with the wearable device for non-invasive multimodal monitoring linked to an App for transfering data. Furthermore, the patient will be able to interact with the application on three times daily by indicating the symptoms contemplated and answering the decision clinical questions. In this way, alarms can be generated in the presence of symptoms or significant alterations in the parameters monitored by the device, which the health professionals of the Primary Care teams included in the study will evaluate at the appropriate time, taking the best decision in each case.
Read the detailed description
As variables to be considered in order to compare the effectiveness of the system against the conventional monitoring protocol, complemented with real-time patient notification of symptoms, certain variables will be collected, such as:
Baseline variables:
- Age, sex, date of COVID-19 positive diagnosis (PCR or antigen test).
- Stage of clinical progression of the disease: according to the Primary Care COVID-19 management
- Information collected in the telephone clinical assessment questionnaire in the home follow-up of the patient with SARS-CoV-2 infection
Variables generated by the study follow-up:
- Vital signs covered by the Bakeey E66 smartwatch device: temperature, respiration rate (RR), heart rate (HR) and oxygen saturation (SatO2)
- Clinical symptoms covered by the Home App for submission by the patient: cough, fever, chest pain, respiratory distress (dyspnoea), vomiting and diarrhoea.
- Conditions
- COVID-19
- Being tested
- Clinical decision support system based on non-invasive multimodal monitoring
- Keywords
- Telemedicine, COVID-19, wearable device, e-Health, Remote monitoring
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support system based on non-invasive multimodal monitoringDevice
Non-invasive multimodal vital signs monitoring with the wearabl to monitor for a period of 10 days after the date of positive diagnosis to COVID-19. The device will be linked to the Home App, which will allow the sending of temperature, HR and RR data to the server every 15 minutes a day and the notification of symptoms by the patient three times a day.
| Study group | Role | What they receive |
|---|---|---|
| Monitored group | Experimental | Monitoring of vital signs and following with the conventional telephone protocol Receives: Device: Clinical decision support system based on non-invasive multimodal monitoring |
| Control group | No intervention | Conventional telephone follow-up by health staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution to severe progression of COVID-19
Measured: One month after inclusion of patients in the study
Need for admission to ICU.
Measured: One month after inclusion of patients in the study
Mortality rate.
Measured: One month after inclusion of patients in the study
Secondary outcomes (6)
Hospital admission rate
Measured: One month after inclusion of patients in the study
Delay to hospital admission
Measured: One month after inclusion of patients in the study
Average hospital stay
Measured: One month after inclusion of patients in the study
Need for invasive mechanical ventilation
Measured: One month after inclusion of patients in the study
Occurrence of major vascular events
Measured: One month after inclusion of patients in the study
Economic cost of the care derived from the episode for the social and health care system.
Measured: One month after inclusion of patients in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start9 Mar 2021
- Primary completion28 Sep 2022
- Study completion28 Dec 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, controlled, randomised clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Increase-Tech
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid, University of Valladolid, Sanidad de Castilla y León
- Responsible party
- Principal investigator, Juan Francisco Arenillas Lara, Increase-Tech
- Investigators
- Juan Francisco Arenillas Lara, PhD, Principal investigator, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802018
- Sponsor's protocol ID
- CASVE-NM-21-508
- Acronym
- SOY+
- Status last verified
- Feb 2023
- First submitted
- 16 Mar 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients With Domiciliary Follow-up
- ClinicalTrials.gov ID
- NCT04802018
- Acronym / sponsor ID
- SOY+ / CASVE-NM-21-508
- Conditions
- COVID-19
- Keywords
- Telemedicine, COVID-19, wearable device, e-Health, Remote monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Increase-TechUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valladolid, University of Valladolid, Sanidad de Castilla y León
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 17 Mar 2021 (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 the study is to provide clinical decision support to healthcare professionals using a wearable for non-invasive multimodal monitoring, allowing early detection of disease progression to severe forms, as well as the detection of significant clinical events.
For the development of the study, 500 individuals with COVID-19 in home confinement will be randomly assigned to form part of the control group, which will be followed conventionally by Primary Care Professionals, or to the experimental group, which will also be provided with the wearable device for non-invasive multimodal monitoring linked to an App for transfering data. Furthermore, the patient will be able to interact with the application on three times daily by indicating the symptoms contemplated and answering the decision clinical questions. In this way, alarms can be generated in the presence of symptoms or significant alterations in the parameters monitored by the device, which the health professionals of the Primary Care teams included in the study will evaluate at the appropriate time, taking the best decision in each case.
Detailed description
As variables to be considered in order to compare the effectiveness of the system against the conventional monitoring protocol, complemented with real-time patient notification of symptoms, certain variables will be collected, such as:
Baseline variables:
- Age, sex, date of COVID-19 positive diagnosis (PCR or antigen test).
- Stage of clinical progression of the disease: according to the Primary Care COVID-19 management
- Information collected in the telephone clinical assessment questionnaire in the home follow-up of the patient with SARS-CoV-2 infection
Variables generated by the study follow-up:
- Vital signs covered by the Bakeey E66 smartwatch device: temperature, respiration rate (RR), heart rate (HR) and oxygen saturation (SatO2)
- Clinical symptoms covered by the Home App for submission by the patient: cough, fever, chest pain, respiratory distress (dyspnoea), vomiting and diarrhoea.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, controlled, randomised clinical trial
| Arm | Type | Receives |
|---|---|---|
| Monitored group | Experimental | Device: Clinical decision support system based on non-invasive multimodal monitoringMonitoring of vital signs and following with the conventional telephone protocol |
| Control group | No intervention | –Conventional telephone follow-up by health staff |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of SARS-CoV-2 disease, detected by PCR or antigen test, performed 72 h prior to patient inclusion in the study.
- Acceptance to sign the informed consent document.
- Possession of a Smartphone or Tablet with Internet connection.
- Possession of mental faculties to participate in the study.
Key exclusion criteria (4 listed)
- Age below the age of health majority (16 years).
- Lack of digital skills to use the Home App.
- Cognitive impairment that prevents the patient from participating in the study.
- Disabling pathology of the upper limb.
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 |
|---|---|---|
| Clinical decision support system based on non-invasive multimodal monitoringNon-invasive multimodal vital signs monitoring with the wearabl to monitor for a period of 10 days after the date of positive diagnosis to COVID-19. The device will be linked to the Home App, which will allow the sending of temperature, HR and RR data to the server every 15 minutes a day and the notification of symptoms by the patient three times a day. | Device | Monitored group |
Primary outcome
Evolution to severe progression of COVID-19
Time frame: One month after inclusion of patients in the study
Need for admission to ICU.
Time frame: One month after inclusion of patients in the study
Mortality rate.
Time frame: One month after inclusion of patients in the study
6 secondary outcomes
Hospital admission rate
Time frame: One month after inclusion of patients in the study
Delay to hospital admission
Time frame: One month after inclusion of patients in the study
Average hospital stay
Time frame: One month after inclusion of patients in the study
Need for invasive mechanical ventilation
Time frame: One month after inclusion of patients in the study
Occurrence of major vascular events
Time frame: One month after inclusion of patients in the study
Economic cost of the care derived from the episode for the social and health care system.
Time frame: One month after inclusion of patients in the study
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 2 Mar 2023.
- 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.
Juan Francisco Arenillas Lara, PhD principal investigator
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support system based on non-invasive multimodal monitoring in people with COVID-19, run by Increase-Tech 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 4 inclusion and 4 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 2 Mar 2023. 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?
Evolution to severe progression of COVID-19 (time frame: One month after inclusion of patients in the study). The study lists 3 primary outcomes in all. 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 2 Mar 2023.