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

NCT05090982 | Unknown

• 2 other identifiers: APHP2111982021-A01859-32
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; shared medical decision-making tool; e-Delphi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Patient satisfaction with the therapeutic decision-making process

  during the intervention

• Assessment of the perceived state of the patient about the intervention

  during the intervention

• Assessment of the psychological state of the patient

  during the intervention

• Assessment of the perceived health state of the patient

  during the intervention

• Assessment of the quality of life of the patient

  during the intervention

Study Arms (1)

Patients with Atopic dermatitis

150 patients with Atopic dermatitis

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

Interventions

Audio recordings during the consultations OTHER

50 patients with audio recordings of the consultation

Patients with Atopic dermatitis

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

50 patients with audio recording of the consultation and Test of the shared medical decision-making tool for modification

Patients with Atopic dermatitis

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

50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation.

Patients with Atopic dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Atopic Dermatitis

You may qualify if:

• 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

You may not qualify if:

• Patient under guardianship or curatorship
• Patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire
• Patient under AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Henri Mondor

Créteil, 64010, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pierre-André Natella, PhD

  Assistance Publique - Hôpitaux Paris

  STUDY DIRECTOR

Central Study Contacts

Khaled Ezzedine, MD

CONTACT

(0)149812504; khaled.ezzedine@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 25, 2021
• Study Start: December 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)