Use of a Mobile Health App in Managing Pediatric Atopic Dermatitis

Avanta Trading

Status: Completed

Conditions: Atopic Dermatitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06412094

242-SSMU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 4 months to 16 years old

Volunteers: No Healthy Volunteers

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,)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Standard care

Sham Comparator group

Description:

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.

Treatment:

Other: Standard care

Standard care with access to the "AtopicApp" mobile application

Active Comparator group

Description:

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

Treatment:

Other: Standard care

Behavioral: Access to the "AtopicApp" mobile application

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

Experimental group

Description:

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).

Treatment:

Behavioral: Virtual oversight through the AtopicApp

Other: Standard care

Behavioral: Access to the "AtopicApp" mobile application