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

Atopic Dermatitis Clinical Trial

— SHADOW  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05090982
• Other study ID #: APHP211198
• Secondary ID: 2021-A01859-32
• Status: Not yet recruiting
• Start date: December 2021
• Est. completion date: November 2022

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Khaled Ezzedine, MD
• Phone: (0)149812504
• Email: khaled.ezzedine[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Hospital Henri Mondor	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.	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	through study completion, an average of 1 year
Secondary	Patient satisfaction with the therapeutic decision-making process	SURE satisfaction score	during the intervention
Secondary	Assessment of the perceived state of the patient about the intervention	Validation tool score CollaboRATE	during the intervention
Secondary	Assessment of the psychological state of the patient	Validation tool score GAD-7	during the intervention
Secondary	Assessment of the perceived health state of the patient	Score of PHQ-9 questionnaire	during the intervention
Secondary	Assessment of the quality of life of the patient	Score of DLQI questionnaire	during the intervention
Secondary	Assessment of the stigmatization perceived by the patient	6-items Stigmatization scale	during the intervention
Secondary	Assessment of the severity perceived by the patient	Atopic Dermatitis Perceived Severity Scale	during the intervention
Secondary	Description of treatment compliance in patients who received the validated tool	Compliance with treatment received	during the intervention