Contribution of a Video Support to Inform the Patient Before a Complementary Examination in Infectious Diseases (AVIEMI)

March 24, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Necker Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Oral and written information
Legal oral and written information given by physicians concerning additional examinations
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.
Other: Oral and written information
Legal oral and written information given by physicians concerning additional examinations
Other: Video information
Explanatory video applied after physician's formal 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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Score of perceived understanding of information after additional examination
Time Frame: up to 7 days
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).
up to 7 days
Failure rate of examinations
Time Frame: up to 7 days
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
up to 7 days
Missing elements
Time Frame: up to 7 days
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
up to 7 days
Impact on caregivers' knowledge
Time Frame: 1 day
using a self-questionnaire
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
URC-CIC Paris Descartes Necker Cochin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Fanny LANTERNIER, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Elisabete GOMES-PIRES, Nurse, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP 230351
  • 2023-A00266-39 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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