Atopic DermatitisSHADOWNCT05090982
Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Audio recordings during the consultations, Audio recordings during the consultations and test of the shared medical decision-making tool for modification and Audio recordings during the consultations and test of the shared medical decision-making tool for validation
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2021to Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Atopic Dermatitis
Who may be able to join
- 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
Who cannot join
- Patient under guardianship or curatorship
- Patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire
- Patient under AME
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital Henri Mondor
Créteil, 64010
Khaled Ezzedine, MD, (0)1 49 81 25 04 ext. +33, khaled.ezzedine@aphp.fr
Khaled Ezzedine, MD
About this study
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.
Read more
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
- Being tested
- Audio recordings during the consultations, Audio recordings during the consultations 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
- Keywords
- Atopic Dermatitis, shared medical decision-making tool, e-Delphi
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio recordings during the consultationsOther
50 patients with audio recordings of the consultation
Audio recordings during the consultations and test of the shared medical decision-making tool for modificationOther
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 validationOther
50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Atopic dermatitis | 150 patients with Atopic dermatitis Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (8)
Patient satisfaction with the therapeutic decision-making process
SURE satisfaction score
Measured: during the intervention
Assessment of the perceived state of the patient about the intervention
Validation tool score CollaboRATE
Measured: during the intervention
Assessment of the psychological state of the patient
Validation tool score GAD-7
Measured: during the intervention
Assessment of the perceived health state of the patient
Score of PHQ-9 questionnaire
Measured: during the intervention
Assessment of the quality of life of the patient
Score of DLQI questionnaire
Measured: during the intervention
Assessment of the stigmatization perceived by the patient
6-items Stigmatization scale
Measured: during the intervention
Assessment of the severity perceived by the patient
Atopic Dermatitis Perceived Severity Scale
Measured: during the intervention
Description of treatment compliance in patients who received the validated tool
Compliance with treatment received
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study startDec 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-André Natella, PhD, Study director, Assistance Publique - Hôpitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090982
- Sponsor's protocol ID
- APHP211198
- Other IDs
- 2021-A01859-32
- Acronym
- SHADOW
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: APHP IS DATA'S OWNER, PLEASE CONTACT BOARD
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Shared Medical Decision-making Tool for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05090982
- Acronym / sponsor ID
- SHADOW / APHP211198
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, shared medical decision-making tool, e-Delphi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 validation150 patients with Atopic dermatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Atopic Dermatitis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship
- Patient with cognitive dysfunction that makes it impossible to communicate effectively or to complete the questionnaire
- Patient under AME
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio recordings during the consultations50 patients with audio recordings of the consultation | Other | Patients with Atopic dermatitis |
| Audio recordings during the consultations and test of the shared medical decision-making tool for modification50 patients with audio recording of the consultation and Test of the shared medical decision-making tool for modification | Other | Patients with Atopic dermatitis |
| Audio recordings during the consultations and test of the shared medical decision-making tool for validation50 patients with audio recording of the consultation and test of the shared medical decision-making tool for validation. | Other | Patients with Atopic dermatitis |
Primary outcome
Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation.
Time frame: through study completion, an average of 1 year
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
8 secondary outcomes
Patient satisfaction with the therapeutic decision-making process
Time frame: during the intervention
Assessment of the perceived state of the patient about the intervention
Time frame: during the intervention
Assessment of the psychological state of the patient
Time frame: during the intervention
Assessment of the perceived health state of the patient
Time frame: during the intervention
Assessment of the quality of life of the patient
Time frame: during the intervention
Assessment of the stigmatization perceived by the patient
Time frame: during the intervention
Assessment of the severity perceived by the patient
Time frame: during the intervention
Description of treatment compliance in patients who received the validated tool
Time frame: during the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No. APHP IS DATA'S OWNER, PLEASE CONTACT BOARD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-André Natella, PhD study director
Assistance Publique - Hôpitaux Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khaled Ezzedine, MD ((0)149812504 ext. +33, khaled.ezzedine@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a shared medical decision-making tool in the context of a consultation for atopic dermatitis in a specialized dermatology consultation. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.