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OpenTrials
Completed

NCT Number: NCT06412094

Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

4 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samara State Medical University

Samara, 443079, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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).

Sponsors and collaborators

Lead sponsor

Avanta Trading Ltd.

Industry

Registry information

Official study title

A Comparative Controlled Study of the Effectiveness of Using a Mobile Application in Managing Pediatric Atopic Dermatitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 14, 2024
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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