Clinical trial NCT01253330: Usage, Usability & Effect on Adherence and Clinical Outcomes of Text Message Reminders for Adolescents With Asthma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: CMSText
First posted: 2010-12-03
Enrollment: 61
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: Change from Baseline on ACT at 3 months (1st arm), Change from Baseline on ACT at 6 months (2nd arm)
Secondary outcomes:
measure: The Pediatric Quality of Life Scale Version 4.0 Teen Report (ages 13- 18) (PedsQL)
timeFrame: Change from Baseline on PedsQL at 3 months (1st arm), Change from Baseline on PedsQL at 6 months (2nd arm)
measure: Adherence
timeFrame: Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Maria T Britto, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: