Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Other: Standard care; Behavioral: Access to the "AtopicApp" mobile application; Behavioral: Virtual oversight through the AtopicApp

• Registration Number: NCT06412094
• Lead Sponsor: Avanta Trading Ltd.

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-12-26
• Study Completion: 2022-12-26
• Status Verified: 2024-04
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-11
• Last Update Submitted: 2024-05-11
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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,)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care with access to the "AtopicApp" mobile application	Access to the "AtopicApp" mobile application	Subjects in the experimental and observational groups receive access to the "AtopicApp" mobile application, in addition to receiving standard medical care.
Standard care with access to the "AtopicApp" mobile application with potential virtual oversight	Access to the "AtopicApp" mobile application	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).
Standard care with access to the "AtopicApp" mobile application	Standard care	Subjects in the experimental and observational groups receive access to the "AtopicApp" mobile application, in addition to receiving standard medical care.
Standard care with access to the "AtopicApp" mobile application with potential virtual oversight	Standard care	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).
Standard care	Standard care	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.
Standard care with access to the "AtopicApp" mobile application with potential virtual oversight	Virtual oversight through the AtopicApp	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).

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Samara State Medical University; 🇷🇺 Samara, Russian Federation