Viewing Study NCT06478849



Ignite Creation Date: 2024-07-17 @ 11:58 AM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06478849
Status: RECRUITING
Last Update Posted: 2024-06-27
First Post: 2024-06-03

Brief Title: Adherence and Understanding of a Therapeutic Education Program for Patients With Central Venous Access EDUVVC
Sponsor: Assistance Publique - Hôpitaux de Paris
Organization: Assistance Publique - Hôpitaux de Paris

Study Overview

Official Title: Adherence to and Understanding of a Therapeutic Education Program for Patients With Central Venous Lines
Status: RECRUITING
Status Verified Date: 2024-09
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: EDUVVC
Brief Summary: The aim of this project is to evaluate in a prospective cohort of PICC line patients adherence to the project and understanding of the messages

The transmission of knowledge and the acquisition of skills by patients with this type of invasive device will enable them to play an active role in their own care and could help to reduce the frequency of risks

This project is part of a collaborative approach that includes the creation of a mobile application for therapeutic education and monitoring application under development The evaluation of the device will be the subject of a national PHRC with national structures SPIADI and PRIMO The aim is to create a city-hospital collaboration to improve risk management
Detailed Description: The ever-increasing use of central venous lines including PICC lines and the shift in medical practice towards ambulatory care are making it increasingly complex to prevent the infectious and non-infectious risks associated with their use

The involvement of numerous healthcare professionals within and outside the hospital with varying levels of training exposes patients to numerous complications the incidence of which depending on the device ranges from 6 to 16 and occur at the time of insertion hematoma pneumothorax necrosis or during use infection thrombosis extravasation

The transmission of knowledge and the acquisition of skills by patients wearing this type of invasive device helps to make the patient a player in his or her own care and could help to reduce the frequency of risks As part of a therapeutic education program we aim to validate the communication tools and messages identified by a panel of French experts These messages together with the article published by Petit et al have enabled us to draw up a skills reference framework for patients with a PICC line

The aim of this project is to evaluate adherence to the project and understanding of the messages on a prospective cohort of patients

This project is part of a collaborative approach that includes the creation of a mobile application for therapeutic education and monitoring application under development The evaluation of the device will be the subject of a national PHRC with national structures SPIADI and PRIMO The aim is to create a city-hospital collaboration to improve risk management

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