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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253330
• Other study ID #: 20090445
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: February 11, 2016
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2016
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 22 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	CMSText

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test (ACT)	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.	Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)	No
Secondary	The Pediatric Quality of Life Scale Version 4.0 Teen Report (ages 13- 18) (PedsQL)	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.")	Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)	No
Secondary	Adherence	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.	Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)	No