Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care

NCT ID: NCT02176694

Last Updated: 2016-06-10

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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A randomized controlled trial of a texting intervention to increase adherence to preventative asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.

Detailed Description

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Our first aim is to determine the feasibility, acceptability and use of a low intensity text messaging intervention to improve adherence to inhaled corticosteroid (ICS) therapy among high risk adolescents with persistent asthma. Our second aim is to determine effect sizes of the intervention to improve adherence (As measured by electronic monitoring and self-report); clinical asthma control; and asthma related quality of life among adolescents with persistent asthma. Our third and final aim is to determine the temporal relationship between text message receipt and ICS canister actuation in order to understand mechanisms by which text messaging may increase ICS adherence.

Conditions

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Persistent Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard Care

Aside from the asthma education provided at enrollment and placement of the SmartInhaler (i.e.,electronic monitoring device), adolescents will continue to receive usual care through their primary care providers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Text Messaging

A technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones.

Group Type EXPERIMENTAL

Text Messaging

Intervention Type BEHAVIORAL

Website that allows adolescents to create, schedule and send one-time or recurring text messages that will serve as a reminder to take asthma medication or follow up with another health-related matter.

Interventions

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Text Messaging

Website that allows adolescents to create, schedule and send one-time or recurring text messages that will serve as a reminder to take asthma medication or follow up with another health-related matter.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* provider-diagnosed persistent asthma
* prescription of an ICS in accordance in NHLBI Expert Panel Report 3 guidelines for at least 30 days prior to enrollment
* Asthma Control Test (ACT) score less than 20 (indicating lack of current control)
* no provider-diagnosed exacerbation in the 30 days prior to enrollment
* possession of a text-enabled cell phone and a plan to keep it throughout the study period
* agreement by parents (or participants over 18 years old) to any charges levied by their cell phone carrier for text messages associated with the study if they do not have an unlimited texting plan
* speak and read English

Exclusion Criteria

* another chronic lung disease (which would complicate measurement of asthma control)
* cognitive or psychiatric disorder that the treating clinician judges would impair study participation
* use of Advair diskus for their ICS (for which no reliable electronic monitor exists)
* current enrollment in another asthma intervention study
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria T. Britto, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

Professor of Pediatrics

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Dodds CM, Britto MT. Learnings from a pragmatic pilot trial of text messaging for high-risk adolescents with asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):546-547. doi: 10.1016/j.anai.2018.02.008. Epub 2018 Feb 9. No abstract available.

Reference Type DERIVED
PMID: 29432968 (View on PubMed)

Other Identifiers

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1R21HL119826-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013-1184

Identifier Type: -

Identifier Source: org_study_id

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