Enhanced Community-Based Asthma Monitoring Through Novel Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility (Retention %)
研究概览
简要总结
The goal of this pilot interventional study is to learn about the implementation of a home monitoring program (using remote study visits and lung function testing) in children with asthma.
The main questions to answer are:
- Do participants find the program to be feasible, acceptable and accessible?
- What factors are associated with completion of the program?
- Does the program have an effect on asthma control and daytime sleepiness?
详细描述
The primary objective of the proposed study is to pilot test implementation of a protocol for enhanced asthma monitoring using novel technology, including mobile spirometry and remote study visits, for rural and medically underserved children with persistent asthma in Delaware and to determine its feasibility, acceptability, and accessibility.
Additionally, the proposed study aims to explore patient and family demographic characteristics and social factors associated with successful completion of the program and to explore the preliminary effect of the enhanced asthma monitoring program on asthma control and sleepiness as a measure of daytime functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Followed by a Primary Care Practice meeting HRSA rural or medically underserved designation status
- •Diagnosis of persistent asthma: on at least 1 controller/ preventative medication for asthma
- •Ability to follow directions and perform study measures, including in-office spirometry at initial visit
- •Access to mobile device with internet connectivity to connect to telehealth visit and mobile spirometer application
排除标准
- •Significant cardiopulmonary disease other than asthma (Examples: Cystic Fibrosis, complex congenital heart disease)
- •Non-English Speaking
研究组 & 干预措施
Pilot study arm for technology-enhanced asthma intervention
All participants will be in the pilot arm for technology-enhanced intervention program.
干预措施: Pilot study arm for technology-enhanced asthma intervention (Behavioral)
结局指标
主要结局
Feasibility (Retention %)
时间窗: 24 weeks
Feasibility will be evaluated by calculating retention rates at week 24.
Acceptability
时间窗: 24 weeks
To measure acceptability, the study-specific Satisfaction and Usability Survey will be used and assessed at item-level. The percentage (%) of participants who respond "agree" or "strongly agree" to each item will be measured.
Accessibility
时间窗: 24 weeks
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
次要结局
- Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.(Baseline and Week 24)
- Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)(Baseline)
- Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)(Baseline)
- Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.(Baseline and Week 24)
- Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.(24 weeks)
- Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)(Baseline)
研究者
Abigail Strang
PI/MD
Nemours Children's Clinic