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

Persistent Asthma Clinical Trial

— ACT Me  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176694
• Other study ID #: 2013-1184
• Secondary ID: 1R21HL119826-01
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: June 9, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 21 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• Persistent Asthma

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Adherence to ICS	Electronic monitor logs	Baseline	No
Primary	Change in objective adherence to ICS	Electronic Monitor Logs	Change from baseline in objective adherence to ICS at 1 month	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No