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

NCT06293768 | Completed

• 1 other identifier: FADOI.05.2018
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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 for 5 days compared to a traditional clinical monitoring.

Conditions

Hospitalization

Keywords

Telemonitoring; Internal Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  7 days

• Difference in the incidence of major complications at the end of the telemonitoring phase

  7 days

Study Arms (4)

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

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

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

Interventions

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.

Group A continuous monitoring; Group B continuous monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fadoi Foundation, Italy: lead

Study Sites (1)

Ospedale di Albano - Polo H2

Roma, Italy

Location

Study Officials

• Andrea Fontanella, MD

  FADOI FOUNDATION

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 5, 2024
• Study Start: September 23, 2019
• Primary Completion: December 31, 2023
• Study Completion: February 20, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)