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Completed

NCT Number: NCT02176694

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

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.

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Key information

Conditions

Persistent Asthma

Age range

12 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text messaging

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.

Primary outcomes

  1. Objective Adherence to ICS

    Time frame: Baseline

    Electronic monitor logs

  2. Change in objective adherence to ICS

    Time frame: Change from baseline in objective adherence to ICS at 1 month

    Electronic Monitor Logs

  3. Change in objective adherence to ICS

    Time frame: Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control

    Electronic Monitor Logs

  4. Change in objective adherence to ICS

    Time frame: Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control

    Electronic Monitor Logs

  5. Change in objective adherence to ICS

    Time frame: Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control

    Electronic Monitor Logs

  6. Change in objective adherence to ICS

    Time frame: Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control

    Electronic Monitor Logs

  7. Feasibility, Acceptability and Usability of the Text Messaging Website

    Time frame: At time of text messaging intervention

    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.

  8. Feasibility, Acceptability and Usability of the Text Messaging Website

    Time frame: up to 1 month 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.

  9. Feasibility, Acceptability and Usability of the Text Messaging Website

    Time frame: up to 2 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.

  10. Feasibility, Acceptability and Usability of the Text Messaging Website

    Time frame: up 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 outcomes

  1. Asthma Control

    Time frame: Baseline

    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.

  2. Change in Asthma Control

    Time frame: Change from Baseline at 1 month

    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.

  3. Change in Asthma Control

    Time frame: Continuous change over time from baseline at 2 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.

  4. Change in Asthma Control

    Time frame: Continuous change over time from baseline at 3 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.

  5. Change in Asthma Control

    Time frame: Continuous change over time from baseline at 4 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.

  6. Change in Asthma Control

    Time frame: Continuous 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.

  7. Asthma Symptoms, Quality of Life, Treatment Barriers

    Time frame: Baseline

    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.

  8. Change in Asthma Symptoms, Quality of Life, Treatment Barriers

    Time frame: Change from Baseline at month 1

    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.

  9. Change in Asthma Symptoms, Quality of Life, Treatment Barriers

    Time frame: Continuous change over time from baseline at 2 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.

  10. Change in Asthma Symptoms, Quality of Life, Treatment Barriers

    Time frame: Continuous change over time from baseline at 3 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.

  11. Change in Asthma Symptoms, Quality of Life, Treatment Barriers

    Time frame: Continuous change over time from baseline at 4 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.

  12. Change in Asthma Symptoms, Quality of Life, Treatment Barriers

    Time frame: Continuous 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: ACT Me

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2014
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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