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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message Reminders
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

12 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Comparison 1st

Participant 1st

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.")
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.

Full Information

First Posted
November 29, 2010
Last Updated
February 11, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
CMSText
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1. Study Identification

Unique Protocol Identification Number
NCT01253330
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
CMSText

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison 1st
Arm Type
No Intervention
Arm Description
Not enrolled in the CMSText website text messaging system during last 3 months of study participation.
Arm Title
Participant 1st
Arm Type
Experimental
Arm Description
Enrollment in the CMSText website text messaging system during first 3 months of study participation.
Intervention Type
Other
Intervention Name(s)
Text Message Reminders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma Control Test (ACT)
Description
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 Outcome Measure Information:
Title
The Pediatric Quality of Life Scale Version 4.0 Teen Report (ages 13- 18) (PedsQL)
Description
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)
Title
Adherence
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria T Britto, M.D., M.P.H.
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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