Therapeutic Education ProgramEDUVVCNCT06478849
Adherence and Understanding of a Therapeutic Education Program for Patients With Central Venous Access (EDUVVC)
An observational study of Therapeutic Education Program and Prevention, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapeutic Education Program, Prevention
- What is being tested?
- QUESTIONNAIRES
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2024to 10 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with recent PICC line insertion, followed at AVICENNE hospital.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Therapeutic Education Program, Prevention
- Being tested
- QUESTIONNAIRES
- Keywords
- central venous line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUESTIONNAIRESOther
Also called WEBINARS
QUESTINNAIRES / WEBINARS
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess patients' level of understanding of communication tools.
The level of comprehension will be assessed on the acquisition of the main messages and will be expressed as a percentage of correct answers.
Measured: WEEK 6 POST INCLUSION
Secondary outcomes (2)
Estimating patient adherence to communication tools
Adherence to communication tools will be assessed by the frequency of participation in the various webinars proposed.
Measured: WEEK 6 POST INCLUSION
Identify individual factors : a- Demographic b- Related to underlying pathology c- Management-related
age, gender, ethnic origin, mother language, lifestyle, place of residence...
Measured: week 6 post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start6 Sep 2024
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Education ProgramStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CAMILLE REINPRECHT, Principal investigator, Hopital AVICENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478849
- Sponsor's protocol ID
- APHP231313
- Acronym
- EDUVVC
- Status last verified
- Oct 2025
- First submitted
- 3 Jun 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to and Understanding of a Therapeutic Education Program for Patients With Central Venous Lines
- ClinicalTrials.gov ID
- NCT06478849
- Acronym / sponsor ID
- EDUVVC / APHP231313
- Conditions
- Therapeutic Education Program, Prevention
- Keywords
- central venous line
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with recent PICC line insertion, followed at AVICENNE hospital.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUESTIONNAIRESAlso: WEBINARSQUESTINNAIRES / WEBINARS | Other | – |
Primary outcome
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.
2 secondary outcomes
Estimating patient adherence to communication tools
Time frame: WEEK 6 POST INCLUSION
Identify individual factors : a- Demographic b- Related to underlying pathology c- Management-related
Time frame: week 6 post inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAMILLE REINPRECHT principal investigator
Hopital AVICENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Therapeutic Education Program and Prevention, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess patients' level of understanding of communication tools. (time frame: WEEK 6 POST INCLUSION). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.