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NCT06412094 Clinical Trial

Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06412094
Other study ID # 242-SSMU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date December 26, 2022

Study information
Verified date April 2024
Source Avanta Trading Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date December 26, 2022
Est. primary completion date December 26, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Months to 16 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Standard care
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.
Behavioral:
• Access to the "AtopicApp" mobile application
Access to the "AtopicApp" mobile application with 1 day after enrollment.
• Virtual oversight through the AtopicApp
Notification of doctor's virtual oversight through the AtopicApp mobile application.

Locations
Country Name City State
Russian Federation Samara State Medical University Samara

Sponsors (1)
Lead Sponsor Collaborator
Avanta Trading Ltd.

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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).
Primary 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).
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