Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care

NCT02176694 | Completed

• 2 other identifiers: 2013-11841R21HL119826-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial of a texting intervention to increase adherence to preventative asthma medication in four Cincinnati Children's Hospital Medical Center primary care clinics.

Conditions

Persistent Asthma

Keywords

persistent asthma; adherence; text message reminders

Outcome Measures

Primary Outcomes (10)

• Objective Adherence to ICS

  Electronic monitor logs

  Baseline

• Change in objective adherence to ICS

  Electronic Monitor Logs

  Change from baseline in objective adherence to ICS at 1 month

• Change in objective adherence to ICS

  Electronic Monitor Logs

  Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control

• Change in objective adherence to ICS

  Electronic Monitor Logs

  Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control

• Change in objective adherence to ICS

  Electronic Monitor Logs

  Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control

• Change in objective adherence to ICS

  Electronic Monitor Logs

  Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control

• Feasibility, Acceptability and Usability of the Text Messaging Website

  The Computer System Usability Questionnaire is a self-reported measure that captures quantitative data about the usability of the computer system. The Cincinnati Bell Usability questionnaire is a self-reported measure that captures quantitative and qualitative data about how easy the system is to use, whether they like using it, as well as likes and dislikes. Use of the computer system is determined through CMSText website login and message logs.

  At time of text messaging intervention

• Feasibility, Acceptability and Usability of the Text Messaging Website

  The Computer System Usability Questionnaire is a self-reported measure that captures quantitative data about the usability of the computer system. The Cincinnati Bell Usability questionnaire is a self-reported measure that captures quantitative and qualitative data about how easy the system is to use, whether they like using it, as well as likes and dislikes. Use of the computer system is determined through CMSText website login and message logs.

  up to 1 month after receiving text messages

• Feasibility, Acceptability and Usability of the Text Messaging Website

  The Computer System Usability Questionnaire is a self-reported measure that captures quantitative data about the usability of the computer system. The Cincinnati Bell Usability questionnaire is a self-reported measure that captures quantitative and qualitative data about how easy the system is to use, whether they like using it, as well as likes and dislikes. Use of the computer system is determined through CMSText website login and message logs.

  up to 2 months after receiving text messages

• Feasibility, Acceptability and Usability of the Text Messaging Website

  The Computer System Usability Questionnaire is a self-reported measure that captures quantitative data about the usability of the computer system. The Cincinnati Bell Usability questionnaire is a self-reported measure that captures quantitative and qualitative data about how easy the system is to use, whether they like using it, as well as likes and dislikes. Use of the computer system is determined through CMSText website login and message logs.

  up to 3 months after receiving text messages

Secondary Outcomes (12)

• Asthma Control

  Baseline

• Change in Asthma Control

  Change from Baseline at 1 month

• Change in Asthma Control

  Continuous change over time from baseline at 2 months in intervention compared to control

• Change in Asthma Control

  Continuous change over time from baseline at 3 months in intervention compared to control

• Change in Asthma Control

  Continuous change over time from baseline at 4 months in intervention compared to control

Study Arms (2)

Standard Care

NO INTERVENTION

Aside from the asthma education provided at enrollment and placement of the SmartInhaler (i.e.,electronic monitoring device), adolescents will continue to receive usual care through their primary care providers.

Text Messaging

EXPERIMENTAL

A technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones.

Behavioral: Text Messaging

Interventions

Text Messaging BEHAVIORAL

Website that allows adolescents to create, schedule and send one-time or recurring text messages that will serve as a reminder to take asthma medication or follow up with another health-related matter.

Text Messaging

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• provider-diagnosed persistent asthma
• prescription of an ICS in accordance in NHLBI Expert Panel Report 3 guidelines for at least 30 days prior to enrollment
• Asthma Control Test (ACT) score less than 20 (indicating lack of current control)
• no provider-diagnosed exacerbation in the 30 days prior to enrollment
• possession of a text-enabled cell phone and a plan to keep it throughout the study period
• agreement by parents (or participants over 18 years old) to any charges levied by their cell phone carrier for text messages associated with the study if they do not have an unlimited texting plan
• speak and read English

You may not qualify if:

• another chronic lung disease (which would complicate measurement of asthma control)
• cognitive or psychiatric disorder that the treating clinician judges would impair study participation
• use of Advair diskus for their ICS (for which no reliable electronic monitor exists)
• current enrollment in another asthma intervention study

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• Dodds CM, Britto MT. Learnings from a pragmatic pilot trial of text messaging for high-risk adolescents with asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):546-547. doi: 10.1016/j.anai.2018.02.008. Epub 2018 Feb 9. No abstract available.

  PMID: 29432968 DERIVED

Study Officials

• Maria T. Britto, M.D., M.P.H.

  Professor of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 10, 2016

Record last verified: 2016-06

Locations

US (1)