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NCT02426814 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02426814
Other study ID # 2015_Spring_Sinai
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date August 2015
Est. completion date July 2023

Study information
Verified date July 2023
Source CoheroHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 11 Years to 19 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mount Sinai Hospital New York New York

Sponsors (2)
Lead Sponsor Collaborator
CoheroHealth Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Real-time medication adherence in patients using mobile app compared to standard care. Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm. 12 weeks
Secondary Asthma control in patients using mobile app compared to standard care 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. 12 weeks
Secondary Change in lung function with use of a mobile health tool for asthma adherence Measure change in spirometry by comparing force expiratory volume at one second [FEV1] and forced vital capacity [FVC] at baseline and 12 week visit. 12 weeks
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