Adapting and Expanding the Asthma-Educator App

July 25, 2023 updated by: Montefiore Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
This group will download the ASTHMAXcel application and use it for the duration of the study
Other: ASTHMAXcel App
ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.
No Intervention: Usual Care Arm
This group will just receive normal provider care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Post-Refinement Baseline, 3 Months
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)
Post-Refinement Baseline, 4 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 2, Week 4 , Week 6 (Pre and Post Refinement)
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)
Post-Refinement Baseline, 3 Month
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)
Post-Refinement Baseline, 3 Month
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)
Post-Refinement Baseline, 3 Month
Emergency Department Visits
Time Frame: Post-Refinement Baseline, 3 Month
Self-Reported Emergency Department (ED) visits
Post-Refinement Baseline, 3 Month
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)
Post-Refinement Baseline, 3 Month
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)
Post-Refinement Baseline, 3 Month
Patient Usage
Time Frame: Baseline, 3 Month
Time spent on app and different screens of app, measured using Google Analytics
Baseline, 3 Month
Health Literacy
Time Frame: Post-Refinement Baseline
Ability for patients to comprehend Newest Vital Sign screening tool
Post-Refinement Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-9083

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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