- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02176694
Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care (ACT Me)
June 9, 2016 updated by: Children's Hospital Medical Center, Cincinnati
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Adherence to ICS
Time Frame: Baseline
|
Electronic monitor logs
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Baseline
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Change in objective adherence to ICS
Time Frame: Change from baseline in objective adherence to ICS at 1 month
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Electronic Monitor Logs
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Change from baseline in objective adherence to ICS at 1 month
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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
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Electronic Monitor Logs
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Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control
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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
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Electronic Monitor Logs
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Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control
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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
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Electronic Monitor Logs
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Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control
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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
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Electronic Monitor Logs
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Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control
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Feasibility, Acceptability and Usability of the Text Messaging Website
Time Frame: At time of text messaging intervention
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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.
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At time of text messaging intervention
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Feasibility, Acceptability and Usability of the Text Messaging Website
Time Frame: up to 1 month after receiving text messages
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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.
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up to 1 month after receiving text messages
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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.
|
up to 2 months after receiving text messages
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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.
|
up to 3 months after receiving text messages
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Change from Baseline at 1 month
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Change in Asthma Control
Time Frame: Continuous change over time from baseline at 2 months in intervention compared to control
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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
Time Frame: Continuous change over time from baseline at 3 months in intervention compared to control
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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
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Change in Asthma Control
Time Frame: Continuous change over time from baseline at 4 months in intervention compared to control
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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
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.
|
Continuous change over time from baseline at 5 months in intervention compared to control
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Asthma Symptoms, Quality of Life, Treatment Barriers
Time Frame: Baseline
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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.
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Baseline
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Change in Asthma Symptoms, Quality of Life, Treatment Barriers
Time Frame: Change from Baseline at month 1
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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
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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.
|
Continuous change over time from baseline at 2 months in intervention compared to control
|
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.
|
Continuous change over time from baseline at 3 months in intervention compared to control
|
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.
|
Continuous change over time from baseline at 4 months in intervention compared to control
|
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.
|
Continuous change over time from baseline at 5 months in intervention compared to control
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Maria T. Britto, M.D., M.P.H., Professor of Pediatrics
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-1184
- 1R21HL119826-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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