Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

Overview

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.

Full Title of Study: “Feasibility of a Mobile Intervention to Increase Adherence to Asthma Medication Among Children Age 11 to 19 in an Urban Setting”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Evidence of ability to monitor medication use at home via a sensor strap
    • Time Frame: 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 Measures

  • Patient feedback for improved design of a mobile adherence tool
    • Time Frame: 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.)
    • Time Frame: 12 weeks
    • Based on questions as part of baseline/followup visits and focus group.

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • Pregnant
  • Foster Care
  • Emancipated minor

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 19 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CoheroHealth
  • Collaborator
    • Icahn School of Medicine at Mount Sinai
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael M Parides, PhD, Principal Investigator, Icahn School of Medicine at Mount Sinai
    • Andrew M Ting, MD, Principal Investigator, Icahn School of Medicine at Mount Sinai

References

Stern L, Berman J, Lumry W, Katz L, Wang L, Rosenblatt L, Doyle JJ. Medication compliance and disease exacerbation in patients with asthma: a retrospective study of managed care data. Ann Allergy Asthma Immunol. 2006 Sep;97(3):402-8.

Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther. 2001 Aug;23(8):1296-310.

Chapman KR, Walker L, Cluley S, Fabbri L. Improving patient compliance with asthma therapy. Respir Med. 2000 Jan;94(1):2-9. Review.

Einarson TR. Drug-related hospital admissions. Ann Pharmacother. 1993 Jul-Aug;27(7-8):832-40. Review.

Bender BG, Rand C. Medication non-adherence and asthma treatment cost. Curr Opin Allergy Clin Immunol. 2004 Jun;4(3):191-5. Review.

Lasmar L, Camargos P, Champs NS, Fonseca MT, Fontes MJ, Ibiapina C, Alvim C, Moura JA. Adherence rate to inhaled corticosteroids and their impact on asthma control. Allergy. 2009 May;64(5):784-9. doi: 10.1111/j.1398-9995.2008.01877.x. Epub 2009 Jan 21.

Patrick H, Williams GC. Self-determination theory: its application to health behavior and complementarity with motivational interviewing. Int J Behav Nutr Phys Act. 2012 Mar 2;9:18. doi: 10.1186/1479-5868-9-18. Review.

McCallum S. Gamification and serious games for personalized health. Stud Health Technol Inform. 2012;177:85-96.

Csikszentmihalyi M, Rathunde K. The measurement of flow in everyday life: toward a theory of emergent motivation. Nebr Symp Motiv. 1992;40:57-97. Review.

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