Pediatric ASTHMA-Educator

The Development and Pilot Testing of a Pediatric Algorithmic Software Tool to Help Manage Asthma (ASTHMA)-Educator

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Pediatric ASTHMA-Educator mobile application

Detailed Description

This project seeks to develop and pilot test the pediatric ASTHMA-Educator mobile application. The study is being conducted at Montefiore Medical Center among pediatric (7-17 years old) patients with persistent asthma. We are collecting process and clinical outcomes in a longitudinal study design.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pediatric ASTHMA-Educator arm; This arm corresponds to the pediatric version of the ASTHMA-Educator mobile application.	Other: Pediatric ASTHMA-Educator mobile application; This intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma emergency department visits	Asthma emergency department visits	Baseline, 2 months, 4 months, 6 months
Asthma hospitalizations	Asthma hospitalizations	Baseline, 2 months, 4 months, 6 months
Asthma-related steroid courses	Asthma-related steroid courses	Baseline, 2 months, 4 months, 6 months
Patient satisfaction measured by the Client Satisfaction Questionnaire-8	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	Asthma knowledge as measured by the Asthma Knowledge Questionnaire	Baseline, 2 months, 4 months, 6 months
Asthma quality of life as measured by the Pediatric Asthma Impact Scale	Patient's asthma quality of life measured by the Pediatric Asthma Impact Scale	Baseline, 2 months, 4 months, 6 months
Self-reported medication adherence	Patients' self-reported medication adherence measured by the Medication Adherence Rating Scale	Baseline, 2 months, 4 months, 6 months

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: Sunit Jariwala, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: April 13, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2013-2693A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share aggregated and deidentified data in the form of abstracts and publications.
• IPD Sharing Supporting Information Type: SAP; 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