Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care (ACT Me)
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| ClinicalTrials.gov Identifier: NCT02176694 |
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Recruitment Status :
Completed
First Posted : June 27, 2014
Last Update Posted : June 10, 2016
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Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Persistent Asthma | Behavioral: Text Messaging | Not Applicable |
Our first aim is to determine the feasibility, acceptability and use of a low intensity text messaging intervention to improve adherence to inhaled corticosteroid (ICS) therapy among high risk adolescents with persistent asthma. Our second aim is to determine effect sizes of the intervention to improve adherence (As measured by electronic monitoring and self-report); clinical asthma control; and asthma related quality of life among adolescents with persistent asthma. Our third and final aim is to determine the temporal relationship between text message receipt and ICS canister actuation in order to understand mechanisms by which text messaging may increase ICS adherence.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 29 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Health Services Research |
| Official Title: | Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care. |
| Study Start Date : | June 2014 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Standard Care
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.
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Experimental: Text Messaging
A technology based system which allows adolescents to compose, schedule and send one-time or recurring text messages to their own cell phones.
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Behavioral: Text Messaging
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. |
Primary Outcome Measures :
- Objective Adherence to ICS [ Time Frame: Baseline ]Electronic monitor logs
- Change in objective adherence to ICS [ Time Frame: Change from baseline in objective adherence to ICS at 1 month ]Electronic Monitor Logs
- Change in objective adherence to ICS [ Time Frame: Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control ]Electronic Monitor Logs
- Change in objective adherence to ICS [ Time Frame: Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control ]Electronic Monitor Logs
- Change in objective adherence to ICS [ Time Frame: Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control ]Electronic Monitor Logs
- Change in objective adherence to ICS [ Time Frame: Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control ]Electronic Monitor Logs
- Feasibility, Acceptability and Usability of the Text Messaging Website [ Time Frame: At time of text messaging intervention ]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.
- Feasibility, Acceptability and Usability of the Text Messaging Website [ Time Frame: up to 1 month after receiving text messages ]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.
- Feasibility, Acceptability and Usability of the Text Messaging Website [ Time Frame: up to 2 months after receiving text messages ]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.
- Feasibility, Acceptability and Usability of the Text Messaging Website [ Time Frame: up to 3 months after receiving text messages ]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.
Secondary Outcome Measures :
- Asthma Control [ Time Frame: Baseline ]The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
- Change in Asthma Control [ Time Frame: Change from Baseline at 1 month ]The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
- Change in Asthma Control [ Time Frame: Continuous change over time from baseline at 2 months in intervention compared to control ]The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
- Change in Asthma Control [ Time Frame: Continuous change over time from baseline at 3 months in intervention compared to control ]The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
- Change in Asthma Control [ Time Frame: Continuous change over time from baseline at 4 months in intervention compared to control ]The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
- Change in Asthma Control [ Time Frame: Continuous change over time from baseline at 5 months in intervention compared to control ]The Asthma Control Test (ACT) are questions that ask about frequency of day and night symptoms, frequency of fast acting inhaler use, environmental triggers, limitations of activities, perception of asthma control, and confidence in ability to manage asthma.
- Asthma Symptoms, Quality of Life, Treatment Barriers [ Time Frame: Baseline ]The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers [ Time Frame: Change from Baseline at month 1 ]The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers [ Time Frame: Continuous change over time from baseline at 2 months in intervention compared to control ]The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers [ Time Frame: Continuous change over time from baseline at 3 months in intervention compared to control ]The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers [ Time Frame: Continuous change over time from baseline at 4 months in intervention compared to control ]The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers [ Time Frame: Continuous change over time from baseline at 5 months in intervention compared to control ]The Pediatric Quality of Life (PEDSQL) Asthma Symptom Scale, the generic core scale and the treatment barriers scale are questions that assess how much asthma has been a problem for them in the last month.
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| Ages Eligible for Study: | 12 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176694
Locations
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Maria T. Britto, M.D., M.P.H. | Professor of Pediatrics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT02176694 |
| Other Study ID Numbers: |
2013-1184 1R21HL119826-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | June 27, 2014 Key Record Dates |
| Last Update Posted: | June 10, 2016 |
| Last Verified: | June 2016 |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
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persistent asthma adherence text message reminders |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |