Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Change in Asthma Control Test (ACT) Score
研究概览
简要总结
The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.
详细描述
The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH).
We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥12 and <21 years
- •Persistent asthma according to national guidelines criteria
- •Asthma Control Test (ACT) score ≤19
- •Prescribed a preventive (controller) asthma medication in the past 6 months
- •Access to a smartphone compatible with the PEAKmAAP and NutriMap
- •Access to the internet
- •Able to read and speak English
排除标准
- •Significant underlying respiratory disease other than asthma, such as cystic fibrosis
- •Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
- •Current smoker
- •Participation in the investigator's or other asthma clinical trials in the previous 6 months
研究组 & 干预措施
PEAKmAAP
The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification.
干预措施: PEAKmAAP (Behavioral)
PEAKmAAP-Data Sharing (DS)
PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time.
干预措施: PEAKmAAP-DS (Behavioral)
Nutrition Map (NutriMap) Usual Care
Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management.
干预措施: NutriMap Usual Care (Behavioral)
结局指标
主要结局
Change in Asthma Control Test (ACT) Score
时间窗: 3 months
The primary outcome measure will be the change from ACT score ≤19 (uncontrolled asthma) to ACT \>19 (controlled asthma) at 3 months. ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma.
次要结局
- Healthcare Utilization(12 months)
- Change in Asthma Control Test (ACT) Score to Access Secondary Outcomes(12 months)
- Composite Asthma Severity Index (CASI) score(12 months)
- Asthma Control Classification(12 months)
- Lung Function and Airway Inflammation(12 months)
- Mediators of Asthma Control(12 months)