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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HL119826-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma 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. | Baseline |
| Change in Asthma Control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria T. Britto, M.D., M.P.H. | Professor of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29432968 | Derived | 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. |
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| 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 |
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 from Baseline at 1 month |
| Change in Asthma 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. | Continuous change over time from baseline at 2 months in intervention compared to control |
| Change in Asthma 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. | Continuous change over time from baseline at 3 months in intervention compared to control |
| Change in Asthma 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. | Continuous change over time from baseline at 4 months in intervention compared to control |
| Change in Asthma 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. | Continuous change over time from baseline at 5 months in intervention compared to control |
| Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Baseline |
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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 from Baseline at month 1 |
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 2 months in intervention compared to control |
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 3 months in intervention compared to control |
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 4 months in intervention compared to control |
| Change in Asthma Symptoms, Quality of Life, Treatment Barriers | 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. | Continuous change over time from baseline at 5 months in intervention compared to control |