Clinical trial NCT05090982: Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis
Official title: Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
shared medical decision-making tool
e-Delphi
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Atopic Dermatitis

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


Eligibility criteria: 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

Primary outcomes:
measure: Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Patient satisfaction with the therapeutic decision-making process
timeFrame: during the intervention
measure: Assessment of the perceived state of the patient about the intervention
timeFrame: during the intervention
measure: Assessment of the psychological state of the patient
timeFrame: during the intervention
measure: Assessment of the perceived health state of the patient
timeFrame: during the intervention
measure: Assessment of the quality of life of the patient
timeFrame: during the intervention
measure: Assessment of the stigmatization perceived by the patient
timeFrame: during the intervention
measure: Assessment of the severity perceived by the patient
timeFrame: during the intervention
measure: Description of treatment compliance in patients who received the validated tool
timeFrame: during the intervention
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hospital Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux Paris
name: Pierre-André Natella, PhD
role: STUDY_DIRECTOR
References: