Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

NCT06412094 | Completed

• 1 other identifier: 242-SSMU
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• 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)

  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).

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

Study Arms (3)

Standard care

SHAM COMPARATOR

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.

Other: Standard care

Standard care with access to the "AtopicApp" mobile application

ACTIVE COMPARATOR

Subjects in the experimental and observational groups receive access to the "AtopicApp" mobile application, in addition to receiving standard medical care.

Other: Standard care; Behavioral: Access to the "AtopicApp" mobile application

Standard care with access to the "AtopicApp" mobile application with potential virtual oversight

EXPERIMENTAL

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).

Other: Standard care; Behavioral: Access to the "AtopicApp" mobile application; Behavioral: Virtual oversight through the AtopicApp

Interventions

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.

Standard care; Standard care with access to the "AtopicApp" mobile application; Standard care with access to the "AtopicApp" mobile application with potential virtual oversight

Access to the "AtopicApp" mobile application BEHAVIORAL

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

Standard care with access to the "AtopicApp" mobile application; Standard care with access to the "AtopicApp" mobile application with potential virtual oversight

Virtual oversight through the AtopicApp BEHAVIORAL

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

Standard care with access to the "AtopicApp" mobile application with potential virtual oversight

Eligibility Criteria

• Age: 4 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with AD and their parents that provided an informed consent to participate in the study

You may not qualify if:

• 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,)

Sponsors & Collaborators

• Avanta Trading Ltd.: lead

Study Sites (1)

Samara State Medical University

Samara, 443079, Russia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Natalia Migacheva, MD, PhD

  Samara State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized controlled study

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 14, 2024
• Study Start: March 1, 2022
• Primary Completion: December 26, 2022
• Study Completion: December 26, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: March 2024
• Access Criteria: Upon request from an interested researcher

Locations

RU (1)