Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

Sponsor

CoheroHealth (Industry)

Overall Status

Completed

CT.gov ID

NCT02426801

Collaborator

Icahn School of Medicine at Mount Sinai (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the feasibility of using a mobile health intervention to improve adherence to asthma medication among adolescents in an urban clinic setting. 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 the feasibility and acceptability of this intervention to patients.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Device: Inhaler sensor Behavioral: Mobile application for asthma adherence	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Feasibility of a Mobile Intervention to Increase Adherence to Asthma Medication Among Children Age 11 to 19 in an Urban Setting

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Patients in this arm were given no intervention. Their self-reported medication adherence was assessed at the baseline (week 0) and follow-up (week 12) visits but during the study period they did not receive any intervention.
Sham Comparator: Medication Sensor Only These patients received the medication use sensor (sham intervention) and downloaded a sham version of the mobile app. Thus, the medication use from these patients was able to be recorded but the patients did not receive reminders or incentives or the ability to see their medication use via the real mobile app. Intervention: inhaler sensor	Device: Inhaler sensor Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.
Experimental: Medication Sensor and Mobile App These patients received the medication use sensor and the mobile app with reminders (intervention arm). Interventions: inhaler sensor and mobile application for asthma adherence	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.

Arm

Intervention/Treatment

No Intervention: Control

Patients in this arm were given no intervention. Their self-reported medication adherence was assessed at the baseline (week 0) and follow-up (week 12) visits but during the study period they did not receive any intervention.

Sham Comparator: Medication Sensor Only

These patients received the medication use sensor (sham intervention) and downloaded a sham version of the mobile app. Thus, the medication use from these patients was able to be recorded but the patients did not receive reminders or incentives or the ability to see their medication use via the real mobile app. Intervention: inhaler sensor

Device: Inhaler sensor

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

Experimental: Medication Sensor and Mobile App

These patients received the medication use sensor and the mobile app with reminders (intervention arm). Interventions: inhaler sensor and mobile application for asthma adherence

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.

Outcome Measures

Primary Outcome Measures

Evidence of ability to monitor medication use at home via a sensor strap [12 weeks]
Ability to measure medication use via the sensor strap and upload that information to the HIPAA (Health Insurance Portability and Accountability Act) compliant server.

Secondary Outcome Measures

Patient feedback for improved design of a mobile adherence tool [12 weeks]
Feedback from patients on the design of the inhaler sensor and mobile app including aesthetics and ease of use.
Acceptability of mobile adherence strategy for adolescents with asthma (Based on questions as part of baseline/followup visits and focus group.) [12 weeks]
Based on questions as part of baseline/followup visits and focus group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 11-19
Asthma diagnosis
Currently on a daily controller medication for Asthma
English-speaking

Exclusion Criteria:

Pregnant
Foster Care
Emancipated minor

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

CoheroHealth
Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Michael M Parides, PhD, Icahn School of Medicine at Mount Sinai
Principal Investigator: Andrew M Ting, MD, Icahn School of Medicine at Mount Sinai