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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Text Message Reminders

• Registration Number: NCT01253330
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Participant 1st	Text Message Reminders	Enrollment in the CMSText website text messaging system during first 3 months of study participation.

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT)	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.

Secondary Outcome Measures

Name	Time	Method
The Pediatric Quality of Life Scale Version 4.0 Teen Report (ages 13- 18) (PedsQL)	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	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.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States