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

• Conditions: Atopic Dermatitis
• Interventions: Other: Audio recordings during the consultations; Other: Audio recordings during the consultations 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

• Registration Number: NCT05090982
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-25
• Study Start: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2021-12-21
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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

Exclusion Criteria

• 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Atopic dermatitis	Audio recordings during the consultations	150 patients with Atopic dermatitis
Patients with Atopic dermatitis	Audio recordings during the consultations and test of the shared medical decision-making tool for validation	150 patients with Atopic dermatitis
Patients with Atopic dermatitis	Audio recordings during the consultations and test of the shared medical decision-making tool for modification	150 patients with Atopic dermatitis

Primary Outcome Measures

Name	Time	Method
Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.	through study completion, an average of 1 year	Qualitative descriptions of the topics discussed by the patient during the therapeutic decision in a specialized dermatology consultation for atopic dermatitis; in other words, to characterize the topics discussed by the patient during the consultation

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with the therapeutic decision-making process	during the intervention	SURE satisfaction score
Assessment of the perceived state of the patient about the intervention	during the intervention	Validation tool score CollaboRATE
Assessment of the psychological state of the patient	during the intervention	Validation tool score GAD-7
Description of treatment compliance in patients who received the validated tool	during the intervention	Compliance with treatment received
Assessment of the perceived health state of the patient	during the intervention	Score of PHQ-9 questionnaire
Assessment of the quality of life of the patient	during the intervention	Score of DLQI questionnaire
Assessment of the stigmatization perceived by the patient	during the intervention	6-items Stigmatization scale
Assessment of the severity perceived by the patient	during the intervention	Atopic Dermatitis Perceived Severity Scale

Trial Locations

Locations (1)

Hospital Henri Mondor; 🇫🇷 Créteil, France