Infectious DiseaseAVIEMINCT06168448
Contribution of a Video Support to Inform the Patient Before a Complementary Examination in Infectious Diseases
An observational study of Infectious Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is that a video tool coupled with standardized information can increase the patient's understanding of the information and thus optimize their medical care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Oral and written information and Video information
- Type of treatment
- Pill or oral medicine
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2023to 14 Feb 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: Hospitalized patients in the Department of Infectious and Tropical Diseases at Hôpital Necker- Enfants maladies. Caregivers working in the Infectious and Tropical Diseases Department at Necker Hospital
Who may be able to join
- Patient aged ≥ 18 years
- French speaking language
- Hospitalized in the Department of Infectious and Tropical Diseases at Hôpital Necker- Enfants malades
- Prescription, for the first time in its medical history, of one of the following complementary examinations:
- Bronchial FibroscopyIRM
- PICC line insertion
- PET Scanner
- No expressed oral opposition
Who cannot join
- Patients with dementia or cognitive impairment
- Non-French-speaking patient
- Caregivers' inclusion Criteria:
- Caregiver belonging at nurse or doctor's category
- Caregiver working in the Infectious and Tropical Diseases Department at Necker Hospital
- No expressed oral opposition
- Caregivers who are not in contact with patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non Interventional Study Evaluating the Contribution of a Video to Patient Information Before a Complementary Examination in Infectious Diseases
The purpose of this study is that a video tool coupled with standardized information can increase the patient's understanding of the information and thus optimize their medical care
Read the detailed description
Patients admitted to the Infectious and Tropical Diseases Department (MIT) undergo a large number of complementary examinations. In view of their specificity, justified by the often lengthy diagnostic process, as well as by the complexity and diversity of the pathologies, the site of infection and the patient's background (adolescents and adults, migrant patients, immunocompromised patients, Human Immunodeficiency Virus, primary immunodeficiencies, organ transplants, patients with haemopathies, marrow transplants, among others). As a matter of practice, the doctor informs the patient of the prescribed examinations, explaining their purpose and procedure, and outlining any benefits and risks.
The intention is to introduce a tool that complements the information usually provided, and that can be of high quality to improve the patient's perception of understanding. To this end, investigators hypothesize that a tool in video format, built in collaboration with the experience of various technical platforms, could make the experience of understanding information more complete and more accessible to all patients.
- Conditions
- Infectious Disease
- Being tested
- Oral and written information, Video information
- Keywords
- Patient information tool, Understanding of delivered information, Complementary examinations, Video information
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral and written informationOther
Legal oral and written information given by physicians concerning additional examinations
Video informationOther
Explanatory video applied after physician's formal information
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : Patients with oral and written information | Group made up of patients hospitalized at that time in the infectious diseases department who met the eligibility criteria set out in the protocol.
This group of patients will receive the legal oral and written information concerning the additional examination prescribed, as usually delivered by their doctor. Receives: Other: Oral and written information | |
| Group 2 : Patients with oral and written information + video information | Group made up of patients hospitalized at that time in the infectious diseases department who met the eligibility criteria set out in the protocol.
This group of patients will receive the legal oral and written information concerning the additional examination prescribed, as usually delivered by their physician, and in addition the video tool will be applied to them. Receives: Other: Oral and written information; Other: Video information | |
| Group 3 : Caregivers | Nurses and physicians working in the infectious and tropical diseases department. This group of caregivers will assess the impact of the intervention on their practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of perceived understanding of information before additional examination
Measure the patient's perception of comprehension prior to the examination, using a self-assessment Numerical Scale (NRS) defined from zero (no comprehension) to ten (perfect comprehension). The assessment will be collected by a caregiver who is not in charge of the patient, within a maximum of 24 hours after the carried out examination.
Measured: up to 7 days
Secondary outcomes (4)
Score of perceived understanding of information after additional examination
Measure the patient's perception of comprehension after the examination, using a self-assessment Numerical Scale (NRS) defined from zero (no comprehension) to ten (perfect comprehension).
Measured: up to 7 days
Failure rate of examinations
A failure is defined as an examination not performed and/or an examination that cannot be interpreted. The failure is recorded upon return from the examination via the report provided by the technical platform and certified by the physician
Measured: up to 7 days
Missing elements
Collection of elements identified as missing by the patient during the examination. A questionnaire will completed by the patient at his return, in a maximum of 24 hours
Measured: up to 7 days
Impact on caregivers' knowledge
using a self-questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start15 Dec 2023
- Primary completion11 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies 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
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Fanny LANTERNIER, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisElisabete GOMES-PIRES, Nurse, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168448
- Sponsor's protocol ID
- APHP 230351
- Other IDs
- 2023-A00266-39
- Acronym
- AVIEMI
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Study Evaluating the Contribution of a Video to Patient Information Before a Complementary Examination in Infectious Diseases
- ClinicalTrials.gov ID
- NCT06168448
- Acronym / sponsor ID
- AVIEMI / APHP 230351
- Conditions
- Infectious Disease
- Keywords
- Patient information tool, Understanding of delivered information, Complementary examinations, Video information
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 13 Dec 2023 (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 purpose of this study is that a video tool coupled with standardized information can increase the patient's understanding of the information and thus optimize their medical care
Detailed description
Patients admitted to the Infectious and Tropical Diseases Department (MIT) undergo a large number of complementary examinations. In view of their specificity, justified by the often lengthy diagnostic process, as well as by the complexity and diversity of the pathologies, the site of infection and the patient's background (adolescents and adults, migrant patients, immunocompromised patients, Human Immunodeficiency Virus, primary immunodeficiencies, organ transplants, patients with haemopathies, marrow transplants, among others). As a matter of practice, the doctor informs the patient of the prescribed examinations, explaining their purpose and procedure, and outlining any benefits and risks.
The intention is to introduce a tool that complements the information usually provided, and that can be of high quality to improve the patient's perception of understanding. To this end, investigators hypothesize that a tool in video format, built in collaboration with the experience of various technical platforms, could make the experience of understanding information more complete and more accessible to all patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 : Patients with oral and written information | – | Other: Oral and written informationGroup made up of patients hospitalized at that time in the infectious diseases department who met the eligibility criteria set out in the protocol. This group of patients will receive the legal oral and written information concerning the additional examination prescribed, as usually delivered by their doctor. |
| Group 2 : Patients with oral and written information + video information | – | Other: Oral and written information, Other: Video informationGroup made up of patients hospitalized at that time in the infectious diseases department who met the eligibility criteria set out in the protocol. This group of patients will receive the legal oral and written information concerning the additional examination prescribed, as usually delivered by their physician, and in addition the video tool will be applied to them. |
| Group 3 : Caregivers | – | –Nurses and physicians working in the infectious and tropical diseases department. This group of caregivers will assess the impact of the intervention on their practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients in the Department of Infectious and Tropical Diseases at Hôpital Necker- Enfants maladies. Caregivers working in the Infectious and Tropical Diseases Department at Necker Hospital
Key inclusion criteria (8 listed)
- Patient aged ≥ 18 years
- French speaking language
- Hospitalized in the Department of Infectious and Tropical Diseases at Hôpital Necker- Enfants malades
- Prescription, for the first time in its medical history, of one of the following complementary examinations:
- No expressed oral opposition
Key exclusion criteria (7 listed)
- Patients with dementia or cognitive impairment
- Non-French-speaking patient
- Caregiver belonging at nurse or doctor's category
- Caregiver working in the Infectious and Tropical Diseases Department at Necker Hospital
- No expressed oral opposition
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 |
|---|---|---|
| Oral and written informationLegal oral and written information given by physicians concerning additional examinations | Other | Group 1 : Patients with oral and written information, Group 2 : Patients with oral and written information + video information |
| Video informationExplanatory video applied after physician's formal information | Other | Group 2 : Patients with oral and written information + video information |
Primary outcome
Score of perceived understanding of information before additional examination
Time frame: up to 7 days
Measure the patient's perception of comprehension prior to the examination, using a self-assessment Numerical Scale (NRS) defined from zero (no comprehension) to ten (perfect comprehension). The assessment will be collected by a caregiver who is not in charge of the patient, within a maximum of 24 hours after the carried out examination.
4 secondary outcomes
Score of perceived understanding of information after additional examination
Time frame: up to 7 days
Failure rate of examinations
Time frame: up to 7 days
Missing elements
Time frame: up to 7 days
Impact on caregivers' knowledge
Time frame: 1 day
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 27 Mar 2026.
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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.
Fanny LANTERNIER, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Elisabete GOMES-PIRES, Nurse principal investigator
Assistance Publique - Hôpitaux de Paris
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 Infectious Disease, 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 8 inclusion and 7 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 27 Mar 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?
Score of perceived understanding of information before additional examination (time frame: up to 7 days). 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 27 Mar 2026.