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

NCT01253330 | Completed

• 1 other identifier: 20090445
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

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.

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

Secondary Outcomes (2)

• 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)

• Adherence

  Change from Baseline in Adherence at 3 months (1st arm), Change from Baseline in Adherence at 6 months (2nd arm)

Study Arms (2)

Comparison 1st

NO INTERVENTION

Not enrolled in the CMSText website text messaging system during last 3 months of study participation.

Participant 1st

EXPERIMENTAL

Enrollment in the CMSText website text messaging system during first 3 months of study participation.

Other: Text Message Reminders

Interventions

Text Message Reminders OTHER

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.

Participant 1st

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• CMSText: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Maria T Britto, M.D., M.P.H.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

US (1)