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

Fadoi Foundation, Italy

Status: Completed

Conditions: Hospitalization

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06293768

FADOI.05.2018

Details and patient eligibility

About

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.

Full 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

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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208 participants in 4 patient groups

Group A continuous monitoring

Experimental group

Description:

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

Treatment:

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

Description:

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

Description:

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

Treatment:

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

Description:

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