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Completed

NCT Number: NCT06478849

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Avicenne

Bobigny, 93000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient opposed to participating in the study
  • Patient does not understand French
  • Patient not affiliated to a French social security scheme
  • Patient under guardianship or curatorship
  • Patient under court protection

Treatment and study plan

questionnaires

Other

QUESTINNAIRES / WEBINARS

Other names: WEBINARS

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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...

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: EDUVVC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2024
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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