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Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents

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ClinicalTrials.gov Identifier: NCT02426814
Recruitment Status : Unknown
Verified March 2017 by CoheroHealth.
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
CoheroHealth

Tracking Information
First Submitted Date  ICMJE April 7, 2015
First Posted Date  ICMJE April 27, 2015
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
Real-time medication adherence in patients using mobile app compared to standard care. [ Time Frame: 12 weeks ]
Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
Real-time medication adherence in patients receiving reminders and incentives compared to standard care. [ Time Frame: 12 weeks ]
Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • Asthma control in patients using mobile app compared to standard care [ Time Frame: 12 weeks ]
    Analysis of the ACT [asthma control test] at baseline and follow up for patients in each arm to assess changes in asthma control with use of the mobile app.
  • Change in lung function with use of a mobile health tool for asthma adherence [ Time Frame: 12 weeks ]
    Measure change in spirometry by comparing force expiratory volume at one second [FEV1] and forced vital capacity [FVC] at baseline and 12 week visit.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
  • Asthma control in patients receiving reminders and incentives compared to standard care [ Time Frame: 12 weeks ]
    Analysis of the ACT [asthma control test] at baseline and follow up for patients in each arm to assess changes in asthma control with use of the mobile app.
  • Change in lung function with use of a mobile health tool for asthma adherence [ Time Frame: 12 weeks ]
    Measure change in spirometry by comparing force expiratory volume at one second [FEV1] and forced vital capacity [FVC] at baseline and 12 week visit.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Official Title  ICMJE Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Brief Summary The purpose of this study is to assess the use of a mobile health intervention to improve adherence to asthma medication among adolescents. The intervention consists of an inhaler sensor strap to monitor asthma inhaler use and a mobile phone application to remind and incentivize patients to use their medication. This study will assess medication use throughout a 12 week study in patients who receive a mobile app with reminders, asthma control as measured by the ACT [asthma control test], and lung function as measured by spirometry.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Device: Inhaler sensor
    Inhaler sensor strap that tracks inhaler use.
  • Behavioral: Mobile application for asthma adherence
    Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.
Study Arms  ICMJE
  • Sham Comparator: Standard Care with Medication Monitoring

    Patients will be given an inhaler sensor to monitor medication use and a sham version of the mobile app that will not include reminders or incentives.

    Intervention: inhaler sensor

    Intervention: Device: Inhaler sensor
  • Experimental: Medication Monitoring and Mobile App

    Patients will be given an inhaler sensor to monitor medication use and a mobile phone application with reminders to allow self-management of medication use.

    Interventions: inhaler sensor and mobile application for asthma adherence

    Interventions:
    • Device: Inhaler sensor
    • Behavioral: Mobile application for asthma adherence
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 24, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 11-19
  • Asthma diagnosis
  • Currently prescribed a hydrofluoroalkane (HFA) asthma controller medication
  • English-speaking
  • Has a smartphone or access to a smartphone or tablet

Exclusion Criteria:

  • Pregnant
  • Foster Care
  • Emancipated minor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02426814
Other Study ID Numbers  ICMJE 2015_Spring_Sinai
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CoheroHealth
Study Sponsor  ICMJE CoheroHealth
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE
Principal Investigator: Andrew Ting, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Michael Parides, PhD Icahn School of Medicine at Mount Sinai
PRS Account CoheroHealth
Verification Date March 2017

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