Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

NCT ID: NCT06412094

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-12-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type SHAM_COMPARATOR

Standard care

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type 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

Intervention Type BEHAVIORAL

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

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).

Group Type EXPERIMENTAL

Standard care

Intervention Type 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

Intervention Type BEHAVIORAL

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

Virtual oversight through the AtopicApp

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type OTHER

Access to the "AtopicApp" mobile application

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

Intervention Type BEHAVIORAL

Virtual oversight through the AtopicApp

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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,)
Minimum Eligible Age

4 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avanta Trading Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Natalia Migacheva, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samara State Medical University

Locations

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Samara State Medical University

Samara, , Russia

Site Status

Countries

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Russia

Other Identifiers

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242-SSMU

Identifier Type: -

Identifier Source: org_study_id

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