Pediatric ASTHMA-Educator

NCT03520881 | Completed

• 1 other identifier: 2013-2693A
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application.

Conditions

Asthma

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• Change from baseline asthma control to 2, 4, and 6 months

  Asthma symptom burden as measured by the Asthma Control Test

  Baseline, 2 months, 4 months, 6 months

Secondary Outcomes (7)

• Patient satisfaction measured by the Client Satisfaction Questionnaire-8

  Baseline, 2 months, 4 months, 6 months

• Change from baseline asthma knowledge to 2 months, 4 months, 6 months

  Baseline, 2 months, 4 months, 6 months

• Asthma quality of life as measured by the Pediatric Asthma Impact Scale

  Baseline, 2 months, 4 months, 6 months

• Self-reported medication adherence

  Baseline, 2 months, 4 months, 6 months

• Asthma emergency department visits

  Baseline, 2 months, 4 months, 6 months

Study Arms (1)

Pediatric ASTHMA-Educator arm

EXPERIMENTAL

This arm corresponds to the pediatric version of the ASTHMA-Educator mobile application.

Other: Pediatric ASTHMA-Educator mobile application

Interventions

Pediatric ASTHMA-Educator mobile application OTHER

This intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos.

Pediatric ASTHMA-Educator arm

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• English-speaking individuals between 7-17 years with:
• Persistent asthma (diagnosis made by a healthcare provider) on a daily controller medication
• Able to give informed consent
• Smartphone (iOS or Android) access

You may not qualify if:

• Use of oral corticosteroids in the 2 weeks prior to the baseline visit
• Pregnancy
• Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
• Patients that previously received the ASTHMA-Educator application

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sunit Jariwala, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is one group (intervention arm only) in this proof of concept study.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 11, 2018
• Study Start: July 1, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

US (1)