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Adapting and Expanding the Asthma-Educator App

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASTHMAXcel App
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring Asthma

Eligibility Criteria

15 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Usual Care Arm

Arm Description

This group will download the ASTHMAXcel application and use it for the duration of the study

This group will just receive normal provider care

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Asthma Symptom Perception
Ability of participants to perceive their asthma symptoms by using the ASTHMAXcel app and a peak flowmeter
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)
Medication Adherence
Self-reported adherence by patient using Medication Adherence Report Scale Score Scale: 10 (min = worse outcome); 50 (max = better outcome)
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)
Emergency Department Visits
Self-Reported Emergency Department (ED) visits
Patient Satisfaction
Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8 Score Scale: 8 (min = worse outcome); 32 (max = better outcome)
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)
Patient Usage
Time spent on app and different screens of app, measured using Google Analytics
Health Literacy
Ability for patients to comprehend Newest Vital Sign screening tool

Full Information

First Posted
April 5, 2019
Last Updated
July 25, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03930381
Brief Title
Adapting and Expanding the Asthma-Educator App
Official Title
Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
This group will download the ASTHMAXcel application and use it for the duration of the study
Arm Title
Usual Care Arm
Arm Type
No Intervention
Arm Description
This group will just receive normal provider care
Intervention Type
Other
Intervention Name(s)
ASTHMAXcel App
Intervention Description
ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.
Primary Outcome Measure Information:
Title
Change from Baseline Asthma Control to 3 Month Asthma Control
Description
Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)
Time Frame
Post-Refinement Baseline, 3 Months
Title
Change from Baseline Asthma Control to 3 Month Asthma Control
Description
Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)
Time Frame
Post-Refinement Baseline, 4 Months
Secondary Outcome Measure Information:
Title
Asthma Symptom Perception
Description
Ability of participants to perceive their asthma symptoms by using the ASTHMAXcel app and a peak flowmeter
Time Frame
Week 2, Week 4 , Week 6 (Pre and Post Refinement)
Title
Asthma Knowledge
Description
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)
Time Frame
Post-Refinement Baseline, 3 Month
Title
Medication Adherence
Description
Self-reported adherence by patient using Medication Adherence Report Scale Score Scale: 10 (min = worse outcome); 50 (max = better outcome)
Time Frame
Post-Refinement Baseline, 3 Month
Title
Asthma Quality of Life
Description
Quality of life of participants, measured by mini-Asthma Quality of Life Questionnaire Score Scale: 15 (min = worse outcome); 105 (max = better outcome)
Time Frame
Post-Refinement Baseline, 3 Month
Title
Emergency Department Visits
Description
Self-Reported Emergency Department (ED) visits
Time Frame
Post-Refinement Baseline, 3 Month
Title
Patient Satisfaction
Description
Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8 Score Scale: 8 (min = worse outcome); 32 (max = better outcome)
Time Frame
Post-Refinement Baseline, 3 Month
Title
Patient Interface Satisfaction
Description
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)
Time Frame
Post-Refinement Baseline, 3 Month
Title
Patient Usage
Description
Time spent on app and different screens of app, measured using Google Analytics
Time Frame
Baseline, 3 Month
Title
Health Literacy
Description
Ability for patients to comprehend Newest Vital Sign screening tool
Time Frame
Post-Refinement Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunit Jariwala, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35691614
Citation
Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
Results Reference
derived

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Adapting and Expanding the Asthma-Educator App

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