Clinical trial NCT06293768: Continuous Wireless Monitoring for Patients in the Internal Medicine UOC. Randomized Controlled Trial (GreenLineH-T)
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."
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalization
Keywords: Telemonitoring
Internal Medicine
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: difference in the incidence of major complications at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: number of acute patients who in seven days reach the criteria to be discharged or ransferred to the subacute ward
timeFrame: 7 days
measure: Difference in the incidence of major complications at the end of the telemonitoring phase
timeFrame: 7 days
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Ospedale di Albano - Polo H2
Study officials:
affiliation: FADOI FOUNDATION
name: Andrea Fontanella, MD
role: STUDY_DIRECTOR
References: