Back to resultsAdolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care (ACT Me)
Primary Purpose
Persistent Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging
Sponsored by
About this trial
This is an interventional health services research trial for Persistent Asthma focused on measuring persistent asthma, adherence, text message reminders
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
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Care
Text Messaging
Arm Description
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.
A technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones.
Outcomes
Primary Outcome Measures
Objective Adherence to ICS
Electronic monitor logs
Change in objective adherence to ICS
Electronic Monitor Logs
Change in objective adherence to ICS
Electronic Monitor Logs
Change in objective adherence to ICS
Electronic Monitor Logs
Change in objective adherence to ICS
Electronic Monitor Logs
Change in objective adherence to ICS
Electronic Monitor Logs
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.
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.
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.
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.
Secondary Outcome Measures
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 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 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 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 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 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.
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 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 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 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 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 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.
Full Information
NCT ID
NCT02176694
First Posted
June 9, 2014
Last Updated
June 9, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT02176694
Brief Title
Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care
Acronym
ACT Me
Official Title
Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Asthma
Keywords
persistent asthma, adherence, text message reminders
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Text Messaging
Arm Type
Experimental
Arm Description
A technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging
Intervention Description
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 Outcome Measure Information:
Title
Objective Adherence to ICS
Description
Electronic monitor logs
Time Frame
Baseline
Title
Change in objective adherence to ICS
Description
Electronic Monitor Logs
Time Frame
Change from baseline in objective adherence to ICS at 1 month
Title
Change in objective adherence to ICS
Description
Electronic Monitor Logs
Time Frame
Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control
Title
Change in objective adherence to ICS
Description
Electronic Monitor Logs
Time Frame
Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control
Title
Change in objective adherence to ICS
Description
Electronic Monitor Logs
Time Frame
Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control
Title
Change in objective adherence to ICS
Description
Electronic Monitor Logs
Time Frame
Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control
Title
Feasibility, Acceptability and Usability of the Text Messaging Website
Description
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.
Time Frame
At time of text messaging intervention
Title
Feasibility, Acceptability and Usability of the Text Messaging Website
Description
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.
Time Frame
up to 1 month after receiving text messages
Title
Feasibility, Acceptability and Usability of the Text Messaging Website
Description
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.
Time Frame
up to 2 months after receiving text messages
Title
Feasibility, Acceptability and Usability of the Text Messaging Website
Description
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.
Time Frame
up to 3 months after receiving text messages
Secondary Outcome Measure Information:
Title
Asthma Control
Description
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.
Time Frame
Baseline
Title
Change in Asthma Control
Description
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.
Time Frame
Change from Baseline at 1 month
Title
Change in Asthma Control
Description
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.
Time Frame
Continuous change over time from baseline at 2 months in intervention compared to control
Title
Change in Asthma Control
Description
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.
Time Frame
Continuous change over time from baseline at 3 months in intervention compared to control
Title
Change in Asthma Control
Description
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.
Time Frame
Continuous change over time from baseline at 4 months in intervention compared to control
Title
Change in Asthma Control
Description
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.
Time Frame
Continuous change over time from baseline at 5 months in intervention compared to control
Title
Asthma Symptoms, Quality of Life, Treatment Barriers
Description
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.
Time Frame
Baseline
Title
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Description
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.
Time Frame
Change from Baseline at month 1
Title
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Description
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.
Time Frame
Continuous change over time from baseline at 2 months in intervention compared to control
Title
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Description
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.
Time Frame
Continuous change over time from baseline at 3 months in intervention compared to control
Title
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Description
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.
Time Frame
Continuous change over time from baseline at 4 months in intervention compared to control
Title
Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Description
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.
Time Frame
Continuous change over time from baseline at 5 months in intervention compared to control
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria T. Britto, M.D., M.P.H.
Organizational Affiliation
Professor of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29432968
Citation
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.
Results Reference
derived
Learn more about this trial
Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care
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