Adapting and Expanding the Asthma-Educator App

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: ASTHMAXcel App

• Registration Number: NCT03930381
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	ASTHMAXcel App	This group will download the ASTHMAXcel application and use it for the duration of the study

Primary Outcome Measures

Name	Time	Method
Change from Baseline Asthma Control to 3 Month Asthma Control	Post-Refinement Baseline, 4 Months	Asthma symptom burden as measured by the Asthma Control Test; Score Scale: 5 (min = worse); 25 (max = better outcome)

Secondary Outcome Measures

Name	Time	Method
Medication Adherence	Post-Refinement Baseline, 3 Month	Self-reported adherence by patient using Medication Adherence Report Scale; Score Scale: 10 (min = worse outcome); 50 (max = better outcome)
Emergency Department Visits	Post-Refinement Baseline, 3 Month	Self-Reported Emergency Department (ED) visits
Patient Satisfaction	Post-Refinement Baseline, 3 Month	Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8; Score Scale: 8 (min = worse outcome); 32 (max = better outcome)
Asthma Symptom Perception	Week 2, Week 4 , Week 6 (Pre and Post Refinement)	Ability of participants to perceive their asthma symptoms by using the ASTHMAXcel app and a peak flowmeter
Asthma Quality of Life	Post-Refinement Baseline, 3 Month	Quality of life of participants, measured by mini-Asthma Quality of Life Questionnaire; Score Scale: 15 (min = worse outcome); 105 (max = better outcome)
Patient Interface Satisfaction	Post-Refinement Baseline, 3 Month	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)
Patient Usage	Baseline, 3 Month	Time spent on app and different screens of app, measured using Google Analytics
Health Literacy	Post-Refinement Baseline	Ability for patients to comprehend Newest Vital Sign screening tool
Asthma Knowledge	Post-Refinement Baseline, 3 Month	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)

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States