Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care (ACT Me)

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.

Study Overview

• Status: Completed
• Conditions: Persistent Asthma
• Intervention / Treatment: Behavioral: Text Messaging

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	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.

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Maria T. Britto, M.D., M.P.H., Professor of Pediatrics

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: adherence; persistent asthma; text message reminders
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2013-1184; 1R21HL119826-01 (U.S. NIH Grant/Contract)