Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- MDI use Competence in Clinic
研究概览
简要总结
Asthma affects over 10 million children in the U.S., and poses a significant health and cost burden. Metered dose inhaler (MDI) is the most common method of treatment. Studies show that up to 80% of patients demonstrate incorrect use of MDIs, which results in suboptimal medication delivery to the lungs.
Asthma control can be followed by symptoms, rescue medication usage and measures of airflow obstruction. Current options to monitor control include an asthma diary (relies on consistent use by the patient), pharmacy records of medication dispensing (dispensing does not equal usage), and peak expiratory flow (PEF) meters (significant variability in technique leading to inconsistent results).
CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control. CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler. CapMedic includes a built-in forced expiratory flow in 1 second (FEV1, a measure of airflow) and PEF meter. It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.
详细描述
CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control. CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler. CapMedic includes a built-in forced expiratory flow in 1 second (FEV1, a measure of airflow) and PEF meter. It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.
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 (Participant)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Asthma
- •Regular user of MDI
- •Asthma Control Test (ACT) scores between 15 and 25
- •FEV1 between 60-80% of predicted (persistent mild-moderate)
- •Disease severity in the range mild-moderate
- •Access to a Smartphone and internet during the entire duration of the study.
- •Cognitively able to utilize the device and express interest in participating.
排除标准
- •Patients without asthma
- •With developmental disabilities
- •Do not speak English
- •Do not own a Smartphone
结局指标
主要结局
MDI use Competence in Clinic
时间窗: 1 day
Correctness of Inhaler Use measured using CapMedic device during recruitment. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation
MDI use Competence at home
时间窗: 8 weeks
Correctness of Inhaler Use measured using CapMedic device at home. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation
次要结局
- PEF Lung Function in Clinic(1 day)
- FEV1 Lung Function in Clinic(1 day)
- MDI use Adherence(8 weeks)
- FEV1 Lung Function at home(8 weeks)
- PEF Lung Function at home(8 weeks)