Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Feasibility of Recruitment
研究概览
简要总结
Asthma affects nearly 1 in 10 teenagers in the United States and can seriously impact their health and daily life. Teens are expected to manage their asthma by taking medications correctly and paying attention to symptoms, but this can be hard. Adolescents are still developing the skills needed to manage their thoughts, feelings, and behaviors, and they often receive less help from parents during this time. Because each teen struggles in different ways and at different times, they need support that is personalized and responds to what is happening in the moment.
Smartphones offer a promising way to help teens manage asthma well. However, most existing asthma apps do not use the full range of proven behavior-change strategies or adapt to what the teen is actually doing day to day. To address this gap, our team created Responsive Asthma Care for Teens (ReACT)-a system that collects data about each time an adolescent takes or misses a dose of medication and monitors symptoms. ReACT helps teens set goals, get feedback, notice barriers, and practice problem-solving skills. Early testing showed that teens liked ReACT and that it improved the skills needed for better asthma management.
In this study, the investigators will pilot test ReACT in a study with 160 teens ages 13-17 who have poorly controlled asthma. Teens will be randomly assigned to use ReACT or a comparison intervention for six months. The comparison intervention provides basic asthma education and a place to log symptoms and medication use-similar to what they might normally receive in standard care.
Investigators will look at how well the study procedures work across multiple sites and whether ReACT improves the skills that help teens manage their asthma. The investigators will also explore whether ReACT leads to better asthma control and quality of life. Teens will complete assessments at the start of the study, at three months, and at six months. The investigators will gather information through surveys and objective data such as medication use.
By the end of this project, the investigators will know whether the ReACT system and study protocol are feasible and ready for a larger clinical trial, and will have early estimates of how much ReACT may improve asthma outcomes for teens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for adolescents are: 1) they are between 13-17 years-old; 2) they have a physician-verified diagnosis of persistent asthma for at least 6 months; 3) they have suboptimal asthma control as defined by national asthma guidelines;5 4) they have a daily inhaled corticosteroid prescription that is compatible with the ReACT sensor; and 5) the adolescent-caregiver dyad speak and read English.
排除标准
- •are: 1) the adolescent is currently involved in an asthma management intervention beyond usual care; 2) the adolescent has a comorbid chronic health condition that may impact lung function (e.g., cystic fibrosis); 3) the adolescent has significant cognitive impairment or developmental delay that interferes with study completion, and 4) the adolescent does not have their own smart phone. Consistent with national asthma guidelines, we define suboptimal as control as a score of ≤19 on the Asthma Control Test (ACT) or by endorsing one or more of the following symptoms of on >4 days in the past 2 weeks: (a) use of any short-acting beta-agonist medication, (b) experiencing asthma symptoms (i.e., wheezing, tightness of chest, coughing) during the day or night, (c) nighttime awakening due to asthma, or (d) activity limitation or school absence due to asthma.
结局指标
主要结局
Feasibility of Recruitment
时间窗: 6 months
We will compute frequency statistics to ensure we met our recruitment goal of 50% of the sample self-identifying as a racial/ethnic minority.
Retention
时间窗: 6 months
Retention will be calculated for study arms and compared to the hypothesized rate in one-sample tests. Retention rates for sex subgroups within each arm will also be examined descriptively. Consistent with evidence-based medicine recommendations for evaluating clinical trials, our criterion for success is no more than 20% attrition.
Engagement
时间窗: 6 months
Engagement will be considered a success if the intervention and control groups complete an average of 4/7 (57%) symptom monitoring messages each week.
Acceptability
时间窗: 6 months
The ReAct Satisfaction Questionnaire is an 8-item modification of the Client Satisfaction Questionnaire that assesses overall participant satisfaction with the ReACT intervention. Participants respond on a 4-point scale.
Usability
时间窗: The System Usabiltity Scale is a 10-item measure scored on a 5-point Likert scale. It assesses ease of use, learnability, user conficence, system complexity, and need for technical support.
System Usability Scale
Burden
时间窗: 6 months
We will use the Perceived Ease of Use subscale of the ITUES to measure burden. The subscale consists of 5 items.
Qualitative Acceptability
时间窗: 6 months
We will conduct qualitative interviews with 20% of participants who complete ReACT we will administer a semi-structured interview with questions about features, usability, general impressions, and solicit unstructured feedback.
Feasibility of Recruitment
时间窗: 6 months
We will compute frequency statistics to ensure we met our recruitment goal of 50% of the sample self-identifying as a racial/ethnic minority.
Retention
时间窗: 6 months
Retention will be calculated for study arms and compared to the hypothesized rate in one-sample tests. Retention rates for sex subgroups within each arm will also be examined descriptively. Consistent with evidence-based medicine recommendations for evaluating clinical trials, our criterion for success is no more than 20% attrition.
Engagement
时间窗: 6 months
Engagement will be considered a success if the intervention and control groups complete an average of 4/7 (57%) symptom monitoring messages each week.
Acceptability
时间窗: 6 months
The ReAct Satisfaction Questionnaire is an 8-item modification of the Client Satisfaction Questionnaire that assesses overall participant satisfaction with the ReACT intervention. Participants respond on a 4-point scale.
Usability
时间窗: The System Usabiltity Scale is a 10-item measure scored on a 5-point Likert scale. It assesses ease of use, learnability, user conficence, system complexity, and need for technical support.
System Usability Scale
Burden
时间窗: 6 months
We will use the Perceived Ease of Use subscale of the ITUES to measure burden. The subscale consists of 5 items.
Qualitative Acceptability
时间窗: 6 months
We will conduct qualitative interviews with 20% of participants who complete ReACT we will administer a semi-structured interview with questions about features, usability, general impressions, and solicit unstructured feedback.
次要结局
- Asthma Control Test(Baseline, 3 months, 6 months)
- Pediatric Asthma Quality of Life Questionnaire(Baseline, 3 months, 6 months)
- Asthma Control Test(Baseline, 3 months, 6 months)
- Pediatric Asthma Quality of Life Questionnaire(Baseline, 3 months, 6 months)