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NCT02413528 Clinical Trial

Pilot Study of a Mobile Asthma Adherence Intervention

Asthma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02413528
Other study ID # 2014_Fall_2014_Sinai
Secondary ID
Status Terminated
Phase N/A
First received April 7, 2015
Last updated August 3, 2016
Start date October 2014
Est. completion date April 2015

Study information
Verified date August 2016
Source CoheroHealth
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
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 the study in patients who receive a mobile app with reminders and asthma control as measured by the ACT [asthma control test].

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date April 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 19 Years
Eligibility Inclusion Criteria:

- Age 11-19

- Asthma diagnosis

- Currently on a daily controller HFA (hydrofluoroalkane) medication for Asthma

- English-speaking

- Has a smartphone or access to a smartphone or tablet

Exclusion Criteria:

- Pregnant

- Foster Care

- Emancipated minor

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Inhaler sensor
Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.
Behavioral:
• Mobile application for asthma adherence
Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.

Locations
Country Name City State
n/a

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

Outcome
Type Measure Description Time frame Safety issue
Primary Real-time medication adherence in patients receiving reminders and incentives compared to standard care. Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm. 12 weeks No
Secondary Asthma control in patients receiving reminders and incentives compared to standard care (Analysis of the ACT [asthma control test]) 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 No
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