Pilot Study of a Mobile Asthma Adherence Intervention

NCT02413528 | Terminated

• 1 other identifier: 2014_Fall_2014_Sinai
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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 the study in patients who receive a mobile app with reminders and asthma control as measured by the ACT \[asthma control test\].

Conditions

Asthma

Keywords

Patient Compliance; Mobile Applications

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Asthma control in patients receiving reminders and incentives compared to standard care (Analysis of the ACT [asthma control test])

  12 weeks

Study Arms (2)

Standard Care with Medication Monitoring

SHAM COMPARATOR

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

Medication Monitoring and Mobile App

EXPERIMENTAL

Patients will be given an inhaler sensor to monitor medication use and a mobile phone application that will send them reminders and provide an opportunity to see their own medication use and win incentives for adherence. Interventions: Inhaler sensor and mobile application for asthma adherence

Device: Inhaler sensor; Behavioral: Mobile application for asthma adherence

Interventions

Inhaler sensor DEVICE

Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.

Medication Monitoring and Mobile App; Standard Care with Medication Monitoring

Mobile application for asthma adherence BEHAVIORAL

Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.

Medication Monitoring and Mobile App

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Foster Care
• Emancipated minor

Sponsors & Collaborators

• CoheroHealth: lead
• Icahn School of Medicine at Mount Sinai: collaborator

MeSH Terms

Conditions

Asthma; Patient Compliance

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Andrew M Ting, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Michael M Parides, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 10, 2015
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 4, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share