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

Not Applicable

Withdrawn

• Conditions: Asthma
• Interventions: Device: Inhaler sensor; Behavioral: Mobile application for asthma adherence

• Registration Number: NCT02426814
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-24
• Study First Posted: 2015-04-27
• Study Start: 2015-08
• Status Verified: 2023-07
• Primary Completion: 2023-07
• Study Completion: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medication Monitoring and Mobile App	Inhaler sensor	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
Medication Monitoring and Mobile App	Mobile application for asthma adherence	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
Standard Care with Medication Monitoring	Inhaler sensor	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

Primary Outcome Measures

Name	Time	Method
Real-time medication adherence in patients using mobile app compared to standard care.	12 weeks	Analysis of real-time medication use data in the experimental \[app + sensor\] arm vs the sensor only arm.

Secondary Outcome Measures

Name	Time	Method
Asthma control in patients using mobile app compared to standard care	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	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.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States