Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T) (GreenLineH-T)

February 27, 2024 updated by: Fadoi Foundation, Italy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Ospedale di Albano - Polo H2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A continuous monitoring
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
Device: 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.
No Intervention: Group A standard monitoring
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
Experimental: Group B continuous monitoring
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
Device: 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.
No Intervention: Group B standard monitoring
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward
Time Frame: 7 days
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
7 days
Difference in the incidence of major complications at the end of the telemonitoring phase
Time Frame: 7 days

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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fadoi Foundation, Italy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Andrea Fontanella, MD, FADOI Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FADOI.05.2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings