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Completed

NCT Number: NCT03930381

Adapting and Expanding the Asthma-Educator App

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

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Key information

Conditions

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

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASTHMAXcel App

Other

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

Primary outcomes

  1. Change from Baseline Asthma Control to 3 Month Asthma Control

    Time frame: Post-Refinement Baseline, 3 Months

    Asthma symptom burden as measured by the Asthma Control Test

    Score Scale: 5 (min = worse); 25 (max = better outcome)

  2. Change from Baseline Asthma Control to 3 Month Asthma Control

    Time frame: 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 outcomes

  1. Asthma Symptom Perception

    Time frame: 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

  2. Asthma Knowledge

    Time frame: 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)

  3. Medication Adherence

    Time frame: 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)

  4. Asthma Quality of Life

    Time frame: 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)

  5. Emergency Department Visits

    Time frame: Post-Refinement Baseline, 3 Month

    Self-Reported Emergency Department (ED) visits

  6. Patient Satisfaction

    Time frame: 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)

  7. Patient Interface Satisfaction

    Time frame: 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)

  8. Patient Usage

    Time frame: Baseline, 3 Month

    Time spent on app and different screens of app, measured using Google Analytics

  9. Health Literacy

    Time frame: Post-Refinement Baseline

    Ability for patients to comprehend Newest Vital Sign screening tool

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2019
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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