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

Assistance Publique - Hôpitaux de Paris

Status

Unknown

Conditions

Atopic Dermatitis

Treatments

Other: Audio recordings during the consultations and test of the shared medical decision-making tool for validation

Other: Audio recordings during the consultations

Other: Audio recordings during the consultations and test of the shared medical decision-making tool for modification

Study type

Observational

Funder types

Other

Identifiers

NCT05090982

APHP211198

2021-A01859-32 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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