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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
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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