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NCT02426801 Clinical Trial

Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02426801
Other study ID # 2014_Spring_Feasibility
Secondary ID
Status Completed
Phase N/A
First received April 7, 2015
Last updated April 24, 2015
Start date January 2014
Est. completion date June 2014

Study information
Verified date April 2015
Source CoheroHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 11 Years to 19 Years
Eligibility Inclusion Criteria:

- Age 11-19

- Asthma diagnosis

- Currently on a daily controller medication for Asthma

- English-speaking

Exclusion Criteria:

- Pregnant

- Foster Care

- Emancipated minor

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
CoheroHealth Icahn School of Medicine at Mount Sinai

References & Publications (9)

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

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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. 12 weeks
Secondary 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. 12 weeks
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