Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE April 5, 2019
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • 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
  • 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)
  • 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)
  • 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)
  • Emergency Department Visits [ Time Frame: Post-Refinement Baseline, 3 Month ]
    Self-Reported Emergency Department (ED) visits
  • 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)
  • 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)
  • Patient Usage [ Time Frame: Baseline, 3 Month ]
    Time spent on app and different screens of app, measured using Google Analytics
  • Health Literacy [ Time Frame: Post-Refinement Baseline ]
    Ability for patients to comprehend Newest Vital Sign screening tool
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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)
  • 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)
  • Patient Usage [ Time Frame: Week 6, 2 Month, 4 Month ]
    Time spent on app and different screens of app, measured using Google Analytics
  • Emergency Department Visits [ Time Frame: Post-Refinement Baseline, 2 Month, 4 Month ]
    Self-Reported Emergency Department (ED) visits
  • 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)
  • 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)
  • 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)
  • Health Literacy [ Time Frame: Post-Refinement Baseline ]
    Ability for patients to comprehend Newest Vital Sign screening tool
  • 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)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adapting and Expanding the Asthma-Educator App
Official Title  ICMJE Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Asthma
Intervention  ICMJE Other: ASTHMAXcel App
ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.
Study Arms  ICMJE
  • Experimental: Intervention Arm
    This group will download the ASTHMAXcel application and use it for the duration of the study
    Intervention: Other: ASTHMAXcel App
  • No Intervention: Usual Care Arm
    This group will just receive normal provider care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2021)
80
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2019)
130
Estimated Study Completion Date  ICMJE December 20, 2021
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sunit Jariwala, MD (718) 920-4767 sjariwal@montefiore.org
Contact: Obumneme Njeze, BS (973) 216-1500 obumneme.njeze@einsteinmed.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930381
Other Study ID Numbers  ICMJE 2018-9083
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunit Jariwala, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP