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

NCT05090982 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-12-21

No results posted yet for this study

Summary

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

Conditions

Interventions

OTHER

Audio recordings during the consultations

50 patients with audio recordings of the consultation

OTHER

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

OTHER

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pierre-André Natella, PhD · Assistance Publique - Hôpitaux Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05090982 on ClinicalTrials.gov