HospitalizationGreenLineH-TNCT06293768
Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T)
A study testing continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients) in people with Hospitalization, run by Fadoi Foundation, Italy at 1 site in Italy.
Trial summary
Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2019to 20 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients discharged consecutively from the Internal Medicine Unit or transferred to the subacute ward within 7 days of hospitalization, with Blaylock Risk Assessment Screening (BRASS) ≥ 11 and at least two active pathologies
- Patients discharged consecutively from the UOC Internal Medicine or transferred to the ward of subacute within 7 days of hospitalization, with at least two active pathologies
- Signature of informed consent
Who cannot join
- Patients from RSA and Long-term care
- Terminal cancer patient
- Patients with severe cognitive disability or otherwise unable to tolerate the device
- Patients unable to express valid consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Technological Challenge of Continuous Wireless Monitoring for the Management of Complex Patients in the Internal Medicine Departments: the "Green Line" From the Hospital to the Territory. Randomized Controlled Trial GreenLine H-T."
Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring.
Read the detailed description
FADOI Foundation (Italian Scientific Society of Internal Medicine) has promoted a study in collaboration with the ASL Roma 6, monocentric prospective controlled randomized in open-label in patients admitted to an Internal Medicine Unit and subsequently sent to the subacute or discharged care unit. Specifically, the recruitment will take place in the Internal Medicine of the Albano Hospital - Polo H2 of the ASL Roma 6. The aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring. 50 of the patients undergoing continuous monitoring come from the A group and 100 from group B, same ratio in the control patient group. In fact, the study consists of two patient settings, Group A and Group B. Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization
- Conditions
- Hospitalization
- Being tested
- continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients)
- Keywords
- Telemonitoring, Internal Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients)Device
Patients randomized to the experimental group on discharge or with transfer to the subacute ward will be connected to the system continuous monitoring of Vital Signs(Win@Hospital) continuous system for the continuous monitoring of blood sugar(Dexcom G6)(only for diabetic patients). The system, once applied, does not require the presence of a dedicated person and continuous monitoring in real time. It is set with alerts that are triggered both when the parameters they leave the normal ranges both if the data is not recorded due to technical problems. the data is transmitted in real time on mobile devices in the possession of a doctor and a nurse available 24 hours a day who guarantee the remote control system. Devices. Mobiles also contain the clinical information of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Group A continuous monitoring | Experimental | Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. These patients receive continuous telemonitoring of the patient's clinical condition for 5 days after transfer to the subacute ward Receives: Device: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients) |
| Group A standard monitoring | No intervention | Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. These patients receive standard telemonitoring of the patient's clinical condition for 5 days after transfer to the subacute ward |
| Group B continuous monitoring | Experimental | Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization. These patients receive continuous telemonitoring of the patient's clinical condition for 5 days after discharge to the home Receives: Device: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients) |
| Group B standard monitoring | No intervention | Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization. These patients receive standard telemonitoring of the patient's clinical condition for 5 days after discharge to the home |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the incidence of major complications at 30 days
difference in the number of major complications at 30 days after transfer from the UOC for acute to that for subacute and from the hospital to the home among patients undergoing continuous remote monitoring and those subject to standard monitoring.
Measured: 30 days
Secondary outcomes (2)
number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward
Percentage of patients admitted to Acute Internal Medicine who reach the criteria of transfer to the ward for subacute at 7 days and percentage of patients admitted to Internal Medicine for acute patients who reach the criteria for discharge at home at 7 days
Measured: 7 days
Difference in the incidence of major complications at the end of the telemonitoring phase
Difference in the number of major complications at the end of the telemonitoring phase
/ standard clinical monitoring after transfer from acute to subacute UOC and from the hospital to the home between patients undergoing continuous telemonitoring and those undergoing standard monitoring.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start23 Sep 2019
- Primary completion31 Dec 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies 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
- Single group
- Model description
- The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control). 50 of the patients undergoing continuous monitoring come from the group A and 100 from group B, same ratio in the control group. Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Fontanella, MD, Study director, FADOI FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293768
- Sponsor's protocol ID
- FADOI.05.2018
- Acronym
- GreenLineH-T
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Technological Challenge of Continuous Wireless Monitoring for the Management of Complex Patients in the Internal Medicine Departments: the "Green Line" From the Hospital to the Territory. Randomized Controlled Trial GreenLine H-T."
- ClinicalTrials.gov ID
- NCT06293768
- Acronym / sponsor ID
- GreenLineH-T / FADOI.05.2018
- Conditions
- Hospitalization
- Keywords
- Telemonitoring, Internal Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 5 Mar 2024 (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.
Monocentric prospective controlled randomized in open-label study. The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control), aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring.
Detailed description
FADOI Foundation (Italian Scientific Society of Internal Medicine) has promoted a study in collaboration with the ASL Roma 6, monocentric prospective controlled randomized in open-label in patients admitted to an Internal Medicine Unit and subsequently sent to the subacute or discharged care unit. Specifically, the recruitment will take place in the Internal Medicine of the Albano Hospital - Polo H2 of the ASL Roma 6. The aim of the study is to evaluate in these patients the efficacy of a continuous telemonitoring of the patient's clinical condition for 5 days compared to a traditional clinical monitoring. 50 of the patients undergoing continuous monitoring come from the A group and 100 from group B, same ratio in the control patient group. In fact, the study consists of two patient settings, Group A and Group B. Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study involves the enrollment of 300 patients (150 patients undergoing continuous monitoring and 150 as a control). 50 of the patients undergoing continuous monitoring come from the group A and 100 from group B, same ratio in the control group. Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization
| Arm | Type | Receives |
|---|---|---|
| Group A continuous monitoring | Experimental | Device: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients)Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. These patients receive continuous telemonitoring of the patient's clinical condition for 5 days after transfer to the subacute ward |
| Group A standard monitoring | No intervention | –Group A includes patients admitted to the acute ward who are considered transferable to the ward for subacute by the seventh day of hospitalization. These patients receive standard telemonitoring of the patient's clinical condition for 5 days after transfer to the subacute ward |
| Group B continuous monitoring | Experimental | Device: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients)Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization. These patients receive continuous telemonitoring of the patient's clinical condition for 5 days after discharge to the home |
| Group B standard monitoring | No intervention | –Group B includes patients admitted to the acute ward who are considered dismissible by the seventh day of hospitalization. These patients receive standard telemonitoring of the patient's clinical condition for 5 days after discharge to the home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Patients discharged consecutively from the Internal Medicine Unit or transferred to the subacute ward within 7 days of hospitalization, with Blaylock Risk Assessment Screening (BRASS) ≥ 11 and at least two active pathologies
- Patients discharged consecutively from the UOC Internal Medicine or transferred to the ward of subacute within 7 days of hospitalization, with at least two active pathologies
- Signature of informed consent
Key exclusion criteria (4 listed)
- Patients from RSA and Long-term care
- Terminal cancer patient
- Patients with severe cognitive disability or otherwise unable to tolerate the device
- Patients unable to express valid consent
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 wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients)Patients randomized to the experimental group on discharge or with transfer to the subacute ward will be connected to the system continuous monitoring of Vital Signs(Win@Hospital) continuous system for the continuous monitoring of blood sugar(Dexcom G6)(only for diabetic patients). The system, once applied, does not require the presence of a dedicated person and continuous monitoring in real time. It is set with alerts that are triggered both when the parameters they leave the normal ranges both if the data is not recorded due to technical problems. the data is transmitted in real time on mobile devices in the possession of a doctor and a nurse available 24 hours a day who guarantee the remote control system. Devices. Mobiles also contain the clinical information of each patient. | Device | Group A continuous monitoring, Group B continuous monitoring |
Primary outcome
difference in the incidence of major complications at 30 days
Time frame: 30 days
difference in the number of major complications at 30 days after transfer from the UOC for acute to that for subacute and from the hospital to the home among patients undergoing continuous remote monitoring and those subject to standard monitoring.
2 secondary outcomes
number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward
Time frame: 7 days
Difference in the incidence of major complications at the end of the telemonitoring phase
Time frame: 7 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 5 Mar 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.
Andrea Fontanella, MD study director
FADOI FOUNDATION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients) in people with Hospitalization, run by Fadoi Foundation, Italy at 1 site in Italy.
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 5 Mar 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 Italy. 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?
difference in the incidence of major complications at 30 days (time frame: 30 days). 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 5 Mar 2024.