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A randomized controlled study in children with AD, divided into three groups: a control group without access to the app, an experimental observational group with the app, and an experimental interventional group with potential investigator supervision. Outcome measures included the SCORAD and the POEM scores.
Three study groups: a control group that did not use the mobile health Atopic App, an experimental observational group provided with the mobile app without supervision by the investigators and experimental interventional group provided with the mobile app with potential supervision by the investigators. Upon study enrollment, participants receive recommended treatment plans and instructions for contacting the doctor via messenger for any questions during treatment. Virtual oversight disclosed to participant of the intervention arm, including registration status and regularity of use of the app.
Outcome endpoints are objective severity assessment using the SCORAD scale, and subjective assessment of effectiveness using the POEM scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Sham Comparator | Upon enrollment in the study at the end of the screening visit, participants in all groups receive a recommended treatment plan, according to the clinical severity of the AD, and. are instructed to contact the doctor via messenger for any questions related to their treatment. |
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| Standard care with access to the "AtopicApp" mobile application | Active Comparator | Subjects in the experimental and observational groups receive access to the "AtopicApp" mobile application, in addition to receiving standard medical care. |
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| Standard care with access to the "AtopicApp" mobile application with potential virtual oversight | Experimental | The experimental group receives standard medical care, the AtopicApp mobile application, and information about doctor's virtual oversight through the app (monitoring registration and usage). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care | Other | Recommendation of standard treatment plan, according to the clinical severity of the AD, and. are instruction to contact the doctor via messenger for any questions related to treatment recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Oriented Eczema Measure (POEM) | A subjective tool that focuses on severity of atopic dermatitis as experienced by the patient. POEM scores can range from 0 to 28 (higher score reflects worse severity) | At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2). |
| SCORAD (SCORing Atopic Dermatitis) | A clinical tool for assessing the disease severity and subjective symptoms of atopic dermatitis. The SCORAD score range is between 0 and 103 points (higher score reflects worse severity). | At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natalia Migacheva, MD, PhD | Samara State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samara State Medical University | Samara | 443079 | Russia |
De-identified IPD will be available to qualified researchers upon request by email to the principal investigator.
March 2024
Upon request from an interested researcher
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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randomized controlled study
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| Access to the "AtopicApp" mobile application | Behavioral | Access to the "AtopicApp" mobile application with 1 day after enrollment. |
|
| Virtual oversight through the AtopicApp | Behavioral | Notification of doctor's virtual oversight through the AtopicApp mobile application. |
|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |