Atopic Dermatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERStandard care
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.
BEHAVIORALAccess to the AtopicApp mobile application
Access to the AtopicApp mobile application with 1 day after enrollment.
BEHAVIORALVirtual oversight through the AtopicApp
Notification of doctor's virtual oversight through the AtopicApp mobile application.
Sponsors
Avanta Trading Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
randomized controlled study
Eligibility
Sex/Gender
ALL
Age
4 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children with AD and their parents that provided an informed consent to participate in the study
Exclusion criteria
* previous experience with the Atopic App * participation in affiliated online Atopic School program * presence of concomitant skin disease or pathological conditions that may affect the assessment of effectiveness (severe somatic diseases, mental disorders, oncologic or acute infectious diseases, etc.) * avoidance from registration during consecutive 5 days following the screening visit (for participants in groups 2 or 3,)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Oriented Eczema Measure (POEM) | At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2). | 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) |
| SCORAD (SCORing Atopic Dermatitis) | At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2). | 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). |
Countries
Russia
Outcome results
None listed