Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293768
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2022-02-10
Brief Title:
Continuous Wireless Monitoring for Patients in the Internal Medicine UOC Randomized Controlled Trial GreenLineH-T
Sponsor:
Fadoi Foundation Italy
Organization:
Fadoi Foundation Italy
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GreenLineH-T
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 patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None