- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01253330
Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma
February 11, 2016 updated by: Children's Hospital Medical Center, Cincinnati
Study of the Usage, Usability, Acceptability, and Effect on Adherence and Clinical Outcomes of a Web Based Text Messaging System for Adolescents With Asthma- Phase 2
The purpose of this randomized crossover study is to determine the efficacy of participant designed medication reminders on asthma control, asthma related quality of life,and medication adherence.
In addition, this study will provide data regarding the usage, usability, acceptability of an online system designed for creating text message reminders.
It is hypothesized that the teens receiving text message reminders will report having greater quality of life related to their asthma, a reported increase in the control of their asthma, and increased adherence to their medication regimen compared to those teens that are not receiving the text message reminders.
Study Overview
Detailed Description
Adolescents are typically less adept at managing chronic illnesses and adhering to treatment plans than are parents of younger children.
Adolescents are also typically "early adopters" to technological solutions and text messages are integral in today's teen culture.
Text messages are gaining acceptance in health care both as appointment reminders and direct inquiries.
The purpose of this randomized crossover study is to examine the effect of participant designed medication reminders on asthma control, asthma related quality of life, and medication adherence.
In addition, this study will provide data regarding the usage, usability, and acceptability of an online system designed for creating text message reminders.
Study Type
Interventional
Enrollment (Actual)
61
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 22 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 12 and 22
- Diagnosis of Persistent Asthma
- Receiving care at Cincinnati Children's Hospital Medical Center or affiliate
- Prescription of a controller medication
- Must have a cell phone that receives text messages
- Asthma is not well-controlled based on ACT score
- English Speaking
Exclusion Criteria:
- No diagnosis of persistent asthma
- Receiving asthma care other than at a Cincinnati Children's Hospital Medical Center or affiliate
- Asthma is well-controlled based on ACT score
- Does not have a cell phone that receives text messages or plans to change phones within the next 6 months
- Is not taking a daily asthma controller medication
- Is currently receiving asthma appointment or medication reminder text messages from another source
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Comparison 1st
Not enrolled in the CMSText website text messaging system during last 3 months of study participation.
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Experimental: Participant 1st
Enrollment in the CMSText website text messaging system during first 3 months of study participation.
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During baseline (Participant 1st Arm) or Month 3 Visit (Comparison 1st Arm), the study staff member will demonstrate for the teen how to log-on to the calendar system and set up reminders.
Teens will be able to set their own reminders and add other reminders in addition to those that are asthma related.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Control Test (ACT)
Time Frame: Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)
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The teen will complete the Asthma Control Test (ACT), a validated 5-item Likert scale test that asks them to detail their asthma symptoms.
These are questions consistent with those that would be asked by a clinician (i.e., how many times have you used your fast-acting inhaler in the past four weeks, how often does asthma limit your activities).
The responses to these questions will also be used to calculate the teen's asthma control.
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Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Pediatric Quality of Life Scale Version 4.0 Teen Report (ages 13- 18) (PedsQL)
Time Frame: Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)
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This assessment measures how much asthma has been a problem for them in the last month (i.e., "It is hard for me to be responsible for my medications.",
"I worry about my asthma.")
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Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)
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Adherence
Time Frame: Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)
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Adherence to medication regimen will be monitored with the Smartinhaler Tracker developed by Nexus 6 ltd.
It will record the adherence to medication administered through metered-dose inhalers, which include medication such as Qvar and Flovent.
The Smartinhaler records the time and date medications were taken, whether the canister was shaken appropriately prior to inhalation, and how much the medication was inhaled.
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Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)
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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., Children's Hospital Medical Center, Cincinnati
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
November 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
December 2, 2010
First Posted (Estimate)
December 3, 2010
Study Record Updates
Last Update Posted (Estimate)
February 12, 2016
Last Update Submitted That Met QC Criteria
February 11, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20090445
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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