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

Not Applicable

Completed

• Conditions: Hospitalization
• Interventions: Device: continuous wireless monitoring system of Vital Signs (Win@Hospital) + continuous system for continuous monitoring of blood sugar (Dexcom G6)(only for diabetic patients)

• Registration Number: NCT06293768
• Lead Sponsor: Fadoi Foundation, Italy

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.

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 Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2022-02-10
• Primary Completion: 2023-12-31
• Status Verified: 2024-02
• Study Completion: 2024-02-20
• Study First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A continuous monitoring	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 B continuous monitoring	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

Primary Outcome Measures

Name	Time	Method
difference in the incidence of major complications at 30 days	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.

Secondary Outcome Measures

Name	Time	Method
number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward	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
Difference in the incidence of major complications at the end of the telemonitoring phase	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.

Trial Locations

Locations (1)

Ospedale di Albano - Polo H2; 🇮🇹 Roma, Italy