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

NCT02426814 | Withdrawn

• 1 other identifier: 2015_Spring_Sinai
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Patient Compliance; Mobile Applications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Asthma control in patients using mobile app compared to standard care

  12 weeks

• Change in lung function with use of a mobile health tool for asthma adherence

  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 with reminders to allow self-management of medication use. 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.

Medication Monitoring and Mobile App; Standard Care with Medication Monitoring

Mobile application for asthma adherence BEHAVIORAL

Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.

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 prescribed a hydrofluoroalkane (HFA) asthma controller medication
• 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

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

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 Ting, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Michael 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 27, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)