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

Study Overview
=================
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.

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

Conditions
-----------------
Persistent Asthma

Intervention / Treatment
-----------------
* Behavioral: Text Messaging


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>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. | |
| Experimental: Text Messaging<br>A technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones. | Behavioral: Text Messaging<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Adherence to ICS | Electronic monitor logs | Baseline | 
| Change in objective adherence to ICS | Electronic Monitor Logs | Change from baseline in objective adherence to ICS at 1 month | 
| Change in objective adherence to ICS | Electronic Monitor Logs | Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control | 
| Change in objective adherence to ICS | Electronic Monitor Logs | Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control | 
| Change in objective adherence to ICS | Electronic Monitor Logs | Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control | 
| Change in objective adherence to ICS | Electronic Monitor Logs | Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control | 
| Feasibility, Acceptability and Usability of the Text Messaging Website | 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. | At time of text messaging intervention | 
| Feasibility, Acceptability and Usability of the Text Messaging Website | 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. | up to 1 month after receiving text messages | 
| Feasibility, Acceptability and Usability of the Text Messaging Website | 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. | up to 2 months after receiving text messages | 
| Feasibility, Acceptability and Usability of the Text Messaging Website | 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. | up to 3 months after receiving text messages | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma 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. | Baseline | 
| Change in Asthma 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. | Change from Baseline at 1 month | 
| Change in Asthma 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. | Continuous change over time from baseline at 2 months in intervention compared to control | 
| Change in Asthma 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. | Continuous change over time from baseline at 3 months in intervention compared to control | 
| Change in Asthma 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. | Continuous change over time from baseline at 4 months in intervention compared to control | 
| Change in Asthma 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. | Continuous change over time from baseline at 5 months in intervention compared to control | 
| Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Baseline | 
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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 from Baseline at month 1 | 
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 2 months in intervention compared to control | 
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 3 months in intervention compared to control | 
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 4 months in intervention compared to control | 
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 5 months in intervention compared to control | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
persistent asthma, adherence, text message reminders