Telehealth Enhanced Asthma Management
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
- Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
研究概览
简要总结
This study will conduct a 12-month randomized trial with 48 pediatric patients (aged 6-18 years) with persistent asthma to compare outcomes among patients with follow-up visits managed via telemedicine (TM) vs. in-person (IP) visits.
详细描述
The overarching hypothesis is that utilization of TM for asthma follow-up will result in improved clinical outcomes such as Asthma Control Test (ACT) scores, lung function and medication adherence compared to participants receiving IP follow-up care. The Investigator also hypothesize that TM follow-up will result in higher caregiver satisfaction because families will be able to receive quality subspecialty care in their community (TM) compared to those who travel a distance to receive care (IP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥6- and ≤18 years
- •persistent asthma as defined by national guidelines standards
- •receives care at an ACH asthma subspecialty clinic
- •reside ≤1.5 hour drive from Jonesboro, Springdale, Texarkana, or Fort Smith, AR
排除标准
- •Significant underlying respiratory disease other than asthma, such as cystic fibrosis
- •significant co-morbid conditions, such as individuals with developmental or physical impairments that could interfere with the ability to communicate via interactive video
- •current smoker
- •severe asthma exacerbation requiring intubation in the past 12 months
- •no access to a smartphone or internet
结局指标
主要结局
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
时间窗: At baseline and 12 months
ACT is used for symptoms monitoring as per guidelines and has been identified as an appropriate asthma control composite score in clinical research.
次要结局
- Airway Inflammation via Spirometry(Baseline and 12 months)
- Healthcare Utilization(At baseline, 4 months, 8 months, 12 months)
- Routine Follow up Asthma Visit(At baseline, 4 months, 8 months, 12 months)
- Lung Function via Spirometry(Baseline and 12 months)
- Medication Adherence(At baseline, 4 months, 8 months, 12 months)
- Rescue Medication Use(At baseline, 4 months, 8 months, 12 months)
- Clinic Visit Attendance Rate(At baseline, 4 months, 8 months, 12 months)
- Visit Satisfaction(At baseline, 4 months, 8 months, 12 months)