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Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
CMSText
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01253330
First received: November 29, 2010
Last updated: June 21, 2011
Last verified: June 2011

November 29, 2010
June 21, 2011
November 2010
December 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01253330 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Asthma
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.
  • 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.
    Intervention: Other: Text Message Reminders
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
230
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Both
12 Years to 22 Years
No
Contact: Cassandra M. Dodds, B.S. (513) 803-3144 cassandra.dodds@cchmc.org
Contact: Jennifer K Munafo, M.A. (513)636-3934 jennifer.munafo@cchmc.org
United States
 
NCT01253330
20090445
No
Maria T. Britto, M.D., M.P.H, Cincinnati Children's Hospital Medical Center
Children's Hospital Medical Center, Cincinnati
CMSText
Principal Investigator: Maria T Britto, M.D., M.P.H. Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP