Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

May 11, 2024 updated by: Avanta Trading Ltd.

A Comparative Controlled Study of the Effectiveness of Using a Mobile Application 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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.
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.
Active Comparator: Standard care with 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.
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.
Experimental: Standard care with access to the "AtopicApp" mobile application with potential virtual oversight
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
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.
Behavioral: Virtual oversight through the AtopicApp
Notification of doctor's virtual oversight through the AtopicApp mobile application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 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).
At baseline (screening visit, Day 1) and every 3 months thereafter (visits 1 and 2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avanta Trading Ltd.

Investigators

  • Principal Investigator: Natalia Migacheva, MD, PhD, Samara State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

December 26, 2022

Study Completion (Actual)

December 26, 2022

Study Registration Dates

First Submitted

May 5, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 242-SSMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified IPD will be available to qualified researchers upon request by email to the principal investigator.

IPD Sharing Time Frame

March 2024

IPD Sharing Access Criteria

Upon request from an interested researcher

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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