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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

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.

Condition or disease Intervention/treatment Phase
Asthma Device: Inhaler sensor Behavioral: Mobile application for asthma adherence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Study Start Date : August 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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

Device: Inhaler sensor
Inhaler sensor strap that tracks inhaler use.

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

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02426814


Locations
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United States, New York
Mount Sinai Hospital
New york, New York, United States, 10029
Sponsors and Collaborators
CoheroHealth
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Andrew Ting, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Michael Parides, PhD Icahn School of Medicine at Mount Sinai
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Responsible Party: CoheroHealth
ClinicalTrials.gov Identifier: NCT02426814    
Other Study ID Numbers: 2015_Spring_Sinai
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by CoheroHealth:
Patient Compliance
Mobile Applications
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