Suspended

SHADOWCreation of a Shared Medical Decision-making Tool for Atopic Dermatitis

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Dermatitis+8

+ Dermatitis, Atopic

+ Hypersensitivity

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: December 2021
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactKhaled Ezzedine, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2021

Actual date on which the first participant was enrolled.

Hypothesis/Objective : Patient-centered health care and shared decision making are key components of increasing importance which are recommended by the French Haute Autorite de Sante (HAS) and World Health Organization (WHO). In the context of dermatology and atopic dermatitis, European guidelines has promoted an active involvement from both patients and caregivers in therapeutic decisions at all stages to achieve therapeutic success and the Task Force on Atopic Dermatitis (ETFAD) has promoted the setting of treatment goals in a shared decision with the patient. The main objective of this study is to develop and cross culturally validate a tool dedicated to shared-decision in atopic dermatitis that can be used during routine dermatological consultations. The second objective is to better characterize patients seen in this context and to evaluate patients' satisfaction when empowered by shared decision. Method : We aim to develop a SDMt in AD following the recommendations of the International Patient Decision Aid Standards (IPDAS) collaboration. Development will use a multistep approach: 1) identification of priority domains for patients; 2) Selection of domains to be included in the SDMt for AD; and 3) Creation and testing of the SDMt. Participants will be consecutive adult (>18 years old) patients attending consultation for a AD in medical centres in France (Toulouse, Nantes and Créteil). All participants will provide written consent to participate. The study will be submitted for approbation to the local ethics committees of the University Hospital Centres of Paris and will be conducted according to the Declaration of Helsinki. Step 1: Identification of priority domains for patients Step 2: Selection of domains to be included in the SDMt for AD Step 3: Creation and testing of the SDMt

Official TitleCreation of a Shared Medical Decision-making Tool for Atopic Dermatitis
NCT05090982
Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactKhaled Ezzedine, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

3 inclusion criteria required to participate
Age ≥18 years, male or female.

Patient with atopic dermatitis

Written information given to the patient and no objection from the patient to participate to the study

3 exclusion criteria prevent from participating
Patient under guardianship or curatorship

Patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire

Patient under AME

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hospital Henri Mondor

Créteil, FranceOpen Hospital Henri Mondor in Google Maps
SuspendedOne Study Center