Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis
NCT ID: NCT05090982
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2021-12-31
2022-11-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with Atopic dermatitis
150 patients with Atopic dermatitis
Audio recordings during the consultations
50 patients with audio recordings of the consultation
Audio recordings during the consultations and test of the shared medical decision-making tool for modification
50 patients with audio recording of the consultation and Test of the shared medical decision-making tool for modification
Audio recordings during the consultations and test of the shared medical decision-making tool for validation
50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation.
Interventions
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Audio recordings during the consultations
50 patients with audio recordings of the consultation
Audio recordings during the consultations and test of the shared medical decision-making tool for modification
50 patients with audio recording of the consultation and Test of the shared medical decision-making tool for modification
Audio recordings during the consultations and test of the shared medical decision-making tool for validation
50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation.
Eligibility Criteria
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Inclusion Criteria
* Patient with atopic dermatitis
* Written information given to the patient and no objection from the patient to participate to the study
Exclusion Criteria
* Patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire
* Patient under AME
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Pierre-André Natella, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux Paris
Locations
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Hospital Henri Mondor
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A01859-32
Identifier Type: REGISTRY
Identifier Source: secondary_id
APHP211198
Identifier Type: -
Identifier Source: org_study_id
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