Adolescent Controlled Text Messaging to Improve Asthma Medication Adherence in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in objective adherence to ICS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Text Messaging (Behavioral)
结局指标
主要结局
Change in objective adherence to ICS
时间窗: Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control
Electronic Monitor Logs
Objective Adherence to ICS
时间窗: Baseline
Electronic monitor logs
Feasibility, Acceptability and Usability of the Text Messaging Website
时间窗: 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.
Change in objective adherence to ICS
时间窗: Change from baseline in objective adherence to ICS at 1 month
Electronic Monitor Logs
Change in objective adherence to ICS
时间窗: 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
时间窗: 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
时间窗: Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control
Electronic Monitor Logs
Feasibility, Acceptability and Usability of the Text Messaging Website
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Asthma Symptoms, Quality of Life, Treatment Barriers(Baseline)
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers(Continuous change over time from baseline at 5 months in intervention compared to control)
- Change in Asthma Control(Continuous change over time from baseline at 5 months in intervention compared to control)
- 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)
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers(Change from Baseline at month 1)
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers(Continuous change over time from baseline at 2 months in intervention compared to control)
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers(Continuous change over time from baseline at 3 months in intervention compared to control)
- Change in Asthma Symptoms, Quality of Life, Treatment Barriers(Continuous change over time from baseline at 4 months in intervention compared to control)