Adherence and Understanding of a Therapeutic Education Program for Patients With Central Venous Access (EDUVVC) (EDUVVC)

Adherence to and Understanding of a Therapeutic Education Program for Patients With Central Venous Lines

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bobigny, France, 93000
        • Hopital Avicenne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients with recent PICC line insertion, followed at AVICENNE hospital.

Description

Inclusion Criteria:

  1. Adult patients over 18 years of age
  2. Patients requiring a PICC line
  3. Patients with a means of communication with an Internet connection (computer or cell phone) or an alternative solution (landline telephone)
  4. Patients with a predicted life expectancy of more than 6 weeks

Exclusion Criteria:

  1. Patient opposed to participating in the study
  2. Patient does not understand French
  3. Patient not affiliated to a French social security scheme
  4. Patient under guardianship or curatorship
  5. Patient under court protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess patients' level of understanding of communication tools.
Time Frame: WEEK 6 POST INCLUSION
The level of comprehension will be assessed on the acquisition of the main messages and will be expressed as a percentage of correct answers.
WEEK 6 POST INCLUSION

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimating patient adherence to communication tools
Time Frame: WEEK 6 POST INCLUSION
Adherence to communication tools will be assessed by the frequency of participation in the various webinars proposed.
WEEK 6 POST INCLUSION
Identify individual factors : a- Demographic b- Related to underlying pathology c- Management-related
Time Frame: week 6 post inclusion
age, gender, ethnic origin, mother language, lifestyle, place of residence...
week 6 post inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: CAMILLE REINPRECHT, Hopital Avicenne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Actual)

November 10, 2025

Study Completion (Actual)

November 10, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prevention

Clinical Trials on QUESTIONNAIRES

Subscribe