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

Primary Purpose

Asthma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inhaler sensor
Mobile application for asthma adherence
Sponsored by
CoheroHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Patient Compliance, Mobile Applications

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Standard Care with Medication Monitoring

Medication Monitoring and Mobile App

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 7, 2015
Last Updated
July 24, 2023
Sponsor
CoheroHealth
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02426814
Brief Title
Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Official Title
Assessment of a Mobile Intervention to Increase Adherence to Asthma Medication Among Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoheroHealth
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Patient Compliance, Mobile Applications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care with Medication Monitoring
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Medication Monitoring and Mobile App
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Inhaler sensor
Intervention Description
Inhaler sensor strap that tracks inhaler use.
Intervention Type
Behavioral
Intervention Name(s)
Mobile application for asthma adherence
Intervention Description
Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.
Primary Outcome Measure Information:
Title
Real-time medication adherence in patients using mobile app compared to standard care.
Description
Analysis of real-time medication use data in the experimental [app + sensor] arm vs the sensor only arm.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Asthma control in patients using mobile app compared to standard care
Description
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.
Time Frame
12 weeks
Title
Change in lung function with use of a mobile health tool for asthma adherence
Description
Measure change in spirometry by comparing force expiratory volume at one second [FEV1] and forced vital capacity [FVC] at baseline and 12 week visit.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Ting, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Parides, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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