Clinical trial NCT06478849: Adherence and Understanding of a Therapeutic Education Program for Patients With Central Venous Access (EDUVVC)
Official title: Adherence to and Understanding of a Therapeutic Education Program for Patients With Central Venous Lines
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Therapeutic Education Program
Prevention
Keywords: central venous line
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with recent PICC line insertion, followed at AVICENNE hospital.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess patients' level of understanding of communication tools.
timeFrame: WEEK 6 POST INCLUSION
Secondary outcomes:
measure: Estimating patient adherence to communication tools
timeFrame: WEEK 6 POST INCLUSION
measure: Identify individual factors : a- Demographic b- Related to underlying pathology c- Management-related
timeFrame: week 6 post inclusion
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hopital Avicenne
Study officials:
affiliation: Hopital AVICENNE
name: CAMILLE REINPRECHT
role: PRINCIPAL_INVESTIGATOR
References: