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CompletedNCT02426801Updated Apr 27, 2015

Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

An interventional study of Inhaler sensor and Mobile application for asthma adherence in Asthma, sponsored by CoheroHealth. Completed. Open to participants aged 11 Years to 19 Years. Per ClinicalTrials.gov, last updated 2015-04-27.

Sponsored by CoheroHealth · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
11 Years to 19 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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Keywords

  • Patient Compliance
  • Mobile Applications
  • Medication Adherence
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 16 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

CoheroHealth is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant
  • Foster Care
  • Emancipated minor
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • 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

  • 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 · Behavioral: Mobile application for asthma adherence

Interventions

  • DeviceInhaler sensor

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

  • BehavioralMobile 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.

06

What researchers measure

Primary outcomes

  1. Evidence of ability to monitor medication use at home via a sensor strap

    Ability to measure medication use via the sensor strap and upload that information to the HIPAA (Health Insurance Portability and Accountability Act) compliant server.

    Time frame: 12 weeks

Secondary outcomes

  1. Patient feedback for improved design of a mobile adherence tool

    Feedback from patients on the design of the inhaler sensor and mobile app including aesthetics and ease of use.

    Time frame: 12 weeks

  2. Acceptability of mobile adherence strategy for adolescents with asthma (Based on questions as part of baseline/followup visits and focus group.)

    Based on questions as part of baseline/followup visits and focus group.

    Time frame: 12 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. doi: 10.1016/S1081-1206(10)60808-3. PubMed 17042149 ↗
  • 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. doi: 10.1016/s0149-2918(01)80109-0. PubMed 11558866 ↗
  • Chapman KR, Walker L, Cluley S, Fabbri L. Improving patient compliance with asthma therapy. Respir Med. 2000 Jan;94(1):2-9. doi: 10.1053/rmed.1999.0667. PubMed 10714473 ↗
  • Einarson TR. Drug-related hospital admissions. Ann Pharmacother. 1993 Jul-Aug;27(7-8):832-40. doi: 10.1177/106002809302700702. PubMed 8364259 ↗
  • Bender BG, Rand C. Medication non-adherence and asthma treatment cost. Curr Opin Allergy Clin Immunol. 2004 Jun;4(3):191-5. doi: 10.1097/00130832-200406000-00009. PubMed 15126940 ↗
  • 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. PubMed 19183166 ↗
  • 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. PubMed 22385676 ↗
  • McCallum S. Gamification and serious games for personalized health. Stud Health Technol Inform. 2012;177:85-96. PubMed 22942036 ↗
  • Csikszentmihalyi M, Rathunde K. The measurement of flow in everyday life: toward a theory of emergent motivation. Nebr Symp Motiv. 1992;40:57-97. No abstract available. PubMed 1340523 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02426801
Lead sponsor
CoheroHealth
Collaborators
Icahn School of Medicine at Mount Sinai
Responsible party
Sponsor
First posted
Apr 27, 2015
Start date
Jan 2014
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Apr 27, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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