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An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care

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ClinicalTrials.gov Identifier: NCT03847142
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sunit P. Jariwala, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE February 20, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
Change from baseline asthma quality of life to 2, 6, and 12 months [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • Patient satisfaction measured by the Client Satisfaction Questionnaire-8 [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Patient satisfaction measured by the Client Satisfaction Questionnaire-8
  • Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
  • Change from baseline asthma knowledge to 2 months, 6 months, and 12 months [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Asthma knowledge as measured by the validated KASE asthma questionnaire
  • Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
  • Change from baseline asthma control to 2, 6, and 12 months [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Asthma symptom burden as measured by the Asthma Control Test
  • Depression as measured by the Patient Health Questionnaire-9 [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Depression as measured by the Patient Health Questionnaire-9
  • Number of asthma emergency department visits [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Number of asthma emergency department visits
  • Number of asthma hospitalizations [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Number of asthma hospitalizations
Original Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
  • Patient satisfaction measured by the Client Satisfaction Questionnaire-8 [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Patient satisfaction measured by the Client Satisfaction Questionnaire-8
  • Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire
  • Change from baseline asthma knowledge to 2 months, 6 months, and 12 months [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Asthma knowledge as measured by the validated KASE asthma questionnaire
  • Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire
  • Change from baseline asthma control to 2, 6, and 12 months [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Asthma symptom burden as measured by the Asthma Control Test
  • Depression as measured by the Patient Health Questionnaire-9 [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Depression as measured by the Patient Health Questionnaire-9
  • Asthma emergency department visits [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Asthma emergency department visits
  • Asthma hospitalizations [ Time Frame: Baseline, 2 months, 6 months, 12 months ]
    Asthma hospitalizations
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care
Official Title  ICMJE Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings
Brief Summary Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.
Detailed Description Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Through the randomized controlled trial component, there will be 2 arms, which include the ASTHMAXcel intervention and usual care delivered through the outpatient primary care setting.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Asthma
Intervention  ICMJE
  • Other: ASTHMAXcel mobile application
    ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.
  • Other: Outpatient primary care
    Usual care delivered through the outpatient primary care setting
Study Arms  ICMJE
  • Experimental: ASTHMAXcel arm
    The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma.
    Intervention: Other: ASTHMAXcel mobile application
  • Active Comparator: Usual care arm
    This arm represents usual care delivered in the outpatient primary care setting at the study sites.
    Intervention: Other: Outpatient primary 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: February 18, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

English-speaking individuals >18 years with:

  1. persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication
  2. able to give informed consent
  3. Smartphone (iOS or Android) access

Exclusion Criteria:

  1. use of oral corticosteroids in the 2 weeks prior to the baseline visit
  2. pregnancy
  3. severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
  4. patients that previously received ASTHMAXcel
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sunit Jariwala, MD 8666338255 sjariwal@montefiore.org
Contact: Emine Cosar 8666338255 ecosar@montefiore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03847142
Other Study ID Numbers  ICMJE 2018-9027
R18HS025645 ( U.S. AHRQ Grant/Contract )
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 Not Provided
Responsible Party Sunit P. Jariwala, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sunit Jariwala Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date December 2019

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