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SHADOW
Sponsor study identifier
Secondary identifiers
REGISTRY · IDRCB
observational
150
1 country
1
Study Start
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2021
Actual (reported)October 25, 2021
Actual (reported)December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
150 patients with Atopic dermatitis
50 patients with audio recordings of the consultation
50 patients with audio recording of the consultation and Test of the shared medical decision-making tool for modification
Patients with Atopic Dermatitis
Hospital Henri Mondor
Créteil, 64010, France
Pierre-André Natella, PhD
Assistance Publique - Hôpitaux Paris
First Submitted
September 22, 2021
First Posted
October 25, 2021
Study Start
December 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 2022
Estimated (date passed)50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 21, 2021
Record last verified: 2021-09
APHP IS DATA'S OWNER, PLEASE CONTACT BOARD
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Source: ClinicalTrials.gov.
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