Pediatric ASTHMA-Educator

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03520881
• Other study ID #: 2013-2693A
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: July 1, 2021

Study information

• Verified date: June 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Self-reported medication adherence	Patients' self-reported medication adherence measured by the Medication Adherence Rating Scale	Baseline, 2 months, 4 months, 6 months
Secondary	Asthma emergency department visits	Asthma emergency department visits	Baseline, 2 months, 4 months, 6 months
Secondary	Asthma hospitalizations	Asthma hospitalizations	Baseline, 2 months, 4 months, 6 months
Secondary	Asthma-related steroid courses	Asthma-related steroid courses	Baseline, 2 months, 4 months, 6 months