Adapting and Expanding the Asthma-Educator App

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03930381
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 56
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Other: ASTHMAXcel App	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual CareStudy will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
• Actual Study Start Date: May 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

1. 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

2. 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)

3. 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)

4. 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)

5. Emergency Department Visits [Post-Refinement Baseline, 3 Month]

   Self-Reported Emergency Department (ED) visits

6. 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)

7. 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)

8. Patient Usage [Baseline, 3 Month]

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

9. Health Literacy [Post-Refinement Baseline]

   Ability for patients to comprehend Newest Vital Sign screening tool

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT03930381
• Other Study ID Numbers: 2018-9083
• First Posted: Apr 29, 2019
• Last Update Posted: Aug 23, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Montefiore Medical Center: Asthma
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of Aug 23, 2022