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Adapting and Expanding the Asthma-Educator App

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03930381
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Sunit P. Jariwala, Montefiore Medical Center

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 Not Applicable

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 6 weeks, and will conduct formative and summative evaluation of the application's functionality and usability. The investigators will also be collecting process and clinical outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 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 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
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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



Primary Outcome Measures :
  1. Change from Baseline Asthma Control to 2 Month Asthma Control [ Time Frame: Post-Refinement Baseline, 2 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 4 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 Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Post-Refinement Baseline, 2 Months, 4 Months ]

    Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8

    Score Scale: 8 (min = worse outcome); 32 (max = better outcome)


  2. Patient Interface Satisfaction [ Time Frame: Baseline, Week 6, Post-Refinement Baseline ]

    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)


  3. Patient Usage [ Time Frame: Week 6, 2 Month, 4 Month ]
    Time spent on app and different screens of app, measured using Google Analytics

  4. Emergency Department Visits [ Time Frame: Post-Refinement Baseline, 2 Month, 4 Month ]
    Self-Reported Emergency Department (ED) visits

  5. Asthma Quality of Life [ Time Frame: Post-Refinement Baseline, 2 Month, 4 Month ]

    Quality of life of participants, measured by mini-Asthma Quality of Life Questionnaire

    Score Scale: 15 (min = worse outcome); 105 (max = better outcome)


  6. Airway Obstruction [ Time Frame: Post-Refinement Baseline, 2 Month, 4 Month ]
    Obstruction measure from spirometry (Forced Expiratory Volume (FEV) % predicted and FEV/FVC [Forced Vital Capacity] ratio)

  7. Medication Adherence [ Time Frame: Post-Refinement Baseline, 2 Month, 4 Month ]

    Self-reported adherence by patient using Medication Adherence Report Scale

    Score Scale: 10 (min = worse outcome); 50 (max = better outcome)


  8. Health Literacy [ Time Frame: Post-Refinement Baseline ]
    Ability for patients to comprehend Newest Vital Sign screening tool

  9. Asthma Knowledge [ Time Frame: Post-Refinement Baseline, 2 Month, 4 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)


  10. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930381


Contacts
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Contact: Sunit Jariwala, MD (718) 920-4767 sjariwal@montefiore.org
Contact: Obumneme Njeze, BS (718) 920-4767 onjeze@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Sunit Jariwala, MD    718-920-4767    sjariwal@montefiore.org   
Contact: Obumneme Njeze, BS    (718) 920-4767    onjeze@montefiore.org   
Principal Investigator: Sunit Jariwala, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Sunit Jariwala, MD Montefiore Medical Center
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Responsible Party: Sunit P. Jariwala, Associate Professor (Medicine), Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03930381    
Other Study ID Numbers: 2018-9083
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunit P. Jariwala, Montefiore Medical Center:
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases