NCT06168448

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

December 5, 2023

Last Update Submit

March 24, 2026

Conditions

Keywords

Patient information toolUnderstanding of delivered informationComplementary examinationsVideo information

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 7 days

Secondary Outcomes (4)

  • Score of perceived understanding of information after additional examination

    up to 7 days

  • Failure rate of examinations

    up to 7 days

  • Missing elements

    up to 7 days

  • Impact on caregivers' knowledge

    1 day

Study Arms (3)

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

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 informationOther: 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.

Interventions

Legal oral and written information given by physicians concerning additional examinations

Group 1 : Patients with oral and written informationGroup 2 : Patients with oral and written information + video information

Explanatory video applied after physician's formal information

Group 2 : Patients with oral and written information + video information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Caregivers who are not in contact with patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker Enfants malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fanny LANTERNIER, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR
  • Elisabete GOMES-PIRES, Nurse

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

December 15, 2023

Primary Completion

February 11, 2025

Study Completion

February 14, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations