A Comparative Controlled Study of the Effectiveness of Using a Mobile Application in Managing Pediatric Atopic Dermatitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Avanta Trading Ltd.
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Patient Oriented Eczema Measure (POEM)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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,)
Outcomes
Primary Outcomes
Patient Oriented Eczema Measure (POEM)
Time Frame: 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)
Time Frame: 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).