Feasibility Trial of a Mobile Adherence Tool for Adolescents With Asthma

NCT ID: NCT02426801

Last Updated: 2015-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type SHAM_COMPARATOR

Inhaler sensor

Intervention Type DEVICE

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

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

Group Type EXPERIMENTAL

Inhaler sensor

Intervention Type DEVICE

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

Mobile application for asthma adherence

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inhaler sensor

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

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Pregnant
* Foster Care
* Emancipated minor
Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

CoheroHealth

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael M Parides, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Andrew M Ting, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17042149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11558866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10714473 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8364259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15126940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19183166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22385676 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 22942036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1340523 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014_Spring_Feasibility

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.