CClinicalTrials.gg
CompletedNCT01253330Updated Feb 12, 2016

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

An interventional study of Text Message Reminders in Asthma, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 12 Years to 22 Years. Per ClinicalTrials.gov, last updated 2016-02-12.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
12 Years to 22 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 61 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 22 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • 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

Interventions

  • OtherText 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)

Secondary outcomes

  1. 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.")

    Time frame: Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)

  2. 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.

    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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Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01253330
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
CMSText
Responsible party
Sponsor
First posted
Dec 3, 2010
Start date
Nov 2010
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Feb 12, 2016

Study contacts

Maria T Britto, M.D., M.P.H.
principal investigator · Children's Hospital Medical Center, Cincinnati

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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