Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma
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|ClinicalTrials.gov Identifier: NCT01253330|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : February 12, 2016
|Condition or disease||Intervention/treatment|
|Asthma||Other: Text Message Reminders|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||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|
|Study Start Date :||November 2010|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
No Intervention: Comparison 1st
Not enrolled in the CMSText website text messaging system during last 3 months of study participation.
Experimental: Participant 1st
Enrollment in the CMSText website text messaging system during first 3 months of study participation.
Other: Text Message Reminders
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.
- 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) ]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.
- 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) ]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.")
- Adherence [ Time Frame: Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253330
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Maria T Britto, M.D., M.P.H.||Children's Hospital Medical Center, Cincinnati|