Adapting and Expanding the Asthma-Educator App

Asthma Clinical Trial

Official title:

Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930381
• Other study ID #: 2018-9083
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: July 1, 2023

Study information

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

Clinical Trial Summary

This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.

Description:

The study will test the adapted app on participants ages 15-21 (recruited from outpatient primary and specialty care sites at Montefiore) with asthma, for a period of 4 and a half months, and will conduct formative and summative evaluation of the application's functionality and usability. The investigators will also be collecting process and clinical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 21 Years

Eligibility

Inclusion Criteria:

• English-speaking individuals between 15-21

• 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:
• ASTHMAXcel App
ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.

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 3 Month Asthma Control	Asthma symptom burden as measured by the Asthma Control Test; Score Scale: 5 (min = worse); 25 (max = better outcome)	Post-Refinement Baseline, 3 Months
Primary	Change from Baseline Asthma Control to 3 Month Asthma Control	Asthma symptom burden as measured by the Asthma Control Test; Score Scale: 5 (min = worse); 25 (max = better outcome)	Post-Refinement Baseline, 4 Months
Secondary	Asthma Symptom Perception	Ability of participants to perceive their asthma symptoms by using the ASTHMAXcel app and a peak flowmeter	Week 2, Week 4 , Week 6 (Pre and Post Refinement)
Secondary	Asthma Knowledge	Will use the Child Asthma Illness Representation Survey (AIRS) to asses patients knowledge on asthma as well as their attitudes towards their condition.; Score Scale: 4 (min = worse outcome); 20 (max = better outcome)	Post-Refinement Baseline, 3 Month
Secondary	Medication Adherence	Self-reported adherence by patient using Medication Adherence Report Scale; Score Scale: 10 (min = worse outcome); 50 (max = better outcome)	Post-Refinement Baseline, 3 Month
Secondary	Asthma Quality of Life	Quality of life of participants, measured by mini-Asthma Quality of Life Questionnaire; Score Scale: 15 (min = worse outcome); 105 (max = better outcome)	Post-Refinement Baseline, 3 Month
Secondary	Emergency Department Visits	Self-Reported Emergency Department (ED) visits	Post-Refinement Baseline, 3 Month
Secondary	Patient Satisfaction	Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8; Score Scale: 8 (min = worse outcome); 32 (max = better outcome)	Post-Refinement Baseline, 3 Month
Secondary	Patient Interface Satisfaction	Patient satisfaction with ASTHMAXcel app interface measured by Questionnaire for User Interface Survey (QUIS); Score Scale: 0 (min = worse outcome); 261 (max = better outcome); Answers scale from 0 (terrible/hard to understand)) to 9 (wonderful/easy to understand)	Post-Refinement Baseline, 3 Month
Secondary	Patient Usage	Time spent on app and different screens of app, measured using Google Analytics	Baseline, 3 Month
Secondary	Health Literacy	Ability for patients to comprehend Newest Vital Sign screening tool	Post-Refinement Baseline