- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06478849
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bobigny, France, 93000
- Hôpital Avicenne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
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
Investigators
- Principal Investigator: CAMILLE REINPRECHT, Hôpital Avicenne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP231313
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.