Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

N/ACompletedNCT06412094

Avanta Trading Ltd.66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Standard careOTHER

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.

Access to the "AtopicApp" mobile applicationBEHAVIORAL

Access to the "AtopicApp" mobile application with 1 day after enrollment.

Virtual oversight through the AtopicAppBEHAVIORAL

Notification of doctor's virtual oversight through the AtopicApp mobile application.

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 16 Years

Medical Language ↔ Plain English

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,)

Locations (1)

Samara State Medical University

Samara, Russia

Outcomes

Primary Outcomes

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)

Time frame: 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).

Time frame: At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).

Data from ClinicalTrials.gov

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