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

Not Applicable
Completed
Conditions
Persistent Asthma
Interventions
Behavioral: Text Messaging
Registration Number
NCT02176694
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
29
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Text MessagingText MessagingA technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones.
Primary Outcome Measures
NameTimeMethod
Objective Adherence to ICSBaseline

Electronic monitor logs

Change in objective adherence to ICSContinuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control

Electronic Monitor Logs

Feasibility, Acceptability and Usability of the Text Messaging Websiteup to 3 months after receiving text messages

The Computer System Usability Questionnaire is a self-reported measure that captures quantitative data about the usability of the computer system. The Cincinnati Bell Usability questionnaire is a self-reported measure that captures quantitative and qualitative data about how easy the system is to use, whether they like using it, as well as likes and dislikes. Use of the computer system is determined through CMSText website login and message logs.

Secondary Outcome Measures
NameTimeMethod
Asthma Symptoms, Quality of Life, Treatment BarriersBaseline

The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.

Change in Asthma Symptoms, Quality of Life, Treatment BarriersContinuous change over time from baseline at 5 months in intervention compared to control

The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.

Change in Asthma ControlContinuous change over time from baseline at 5 months in intervention compared to control

The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.

Asthma ControlBaseline

The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center

🇺🇸

Cincinnati, Ohio, United States

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