Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

NCT02426801 | Completed

• 1 other identifier: 2014_Spring_Feasibility
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Patient Compliance; Mobile Applications; Medication Adherence

Outcome Measures

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.

  12 weeks

Secondary Outcomes (2)

• Patient feedback for improved design of a mobile adherence tool

  12 weeks

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

  12 weeks

Study Arms (3)

Control

NO INTERVENTION

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.

Medication Sensor Only

SHAM COMPARATOR

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

Medication Sensor and Mobile App

EXPERIMENTAL

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

Inhaler sensor DEVICE

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

Medication Sensor Only; Medication Sensor and Mobile App

Mobile application for asthma adherence BEHAVIORAL

Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.

Medication Sensor 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 on a daily controller medication for Asthma
• English-speaking

You may not qualify if:

• Pregnant
• Foster Care
• Emancipated minor

Sponsors & Collaborators

• CoheroHealth: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Related Publications (9)

• 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.

  PMID: 17042149 BACKGROUND

• 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.

  PMID: 11558866 BACKGROUND

• 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.

  PMID: 10714473 BACKGROUND

• Einarson TR. Drug-related hospital admissions. Ann Pharmacother. 1993 Jul-Aug;27(7-8):832-40. doi: 10.1177/106002809302700702.

  PMID: 8364259 BACKGROUND

• 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.

  PMID: 15126940 BACKGROUND

• 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.

  PMID: 19183166 BACKGROUND

• 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.

  PMID: 22385676 BACKGROUND

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

  PMID: 22942036 BACKGROUND

• 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.

  PMID: 1340523 BACKGROUND

MeSH Terms

Conditions

Asthma; Patient Compliance; Medication Adherence

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

• Michael M Parides, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Andrew M Ting, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON 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: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 27, 2015

Record last verified: 2015-04