Effectiveness of a Mobile Health Intervention in Improving the Technique of Inhaled Medications Among Children With Asthma: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Does the given mobile health intervention improve inhaler technique in children aged 10-18?
研究概览
简要总结
In this trial, the investigators aim to determine if a new mobile health intervention (BreatheSuite) can increase inhaler technique and adherence amongst participants aged 10-18. See the below detailed description for more information.
详细描述
Improper inhaler technique can significantly affect the amount of medication reaching the lungs and patients with the incorrect technique are likely to have poorly controlled asthma and more emergency department visits. Studies have shown that up to 92% of children demonstrate poor inhaler technique. A systematic review of errors in inhaler technique showed that most errors were in coordination, speed or depth of inspiration, and no post inhalation breath-hold.
BreatheSuite (patent pending) is a device and mobile application developed by Mr. Brett Vokey, an engineering student at Memorial University of Newfoundland. BreatheSuite has been recognized by numerous provincial competitions, featured at the Eastern Health Innovation Showcase, and was recently selected as a finalist for the New York Health Innovation Challenge.
This device attaches to metered dose inhalers and it can determine if:
- the dose was given,
- the metered dose inhaler was properly shaken,
- the metered dose inhaler is properly aligned,
- the flow of medication is appropriate, and
- there is no accidental exhalation into the inhaler.
All of this information is transmitted to the BreatheSuite mobile application, which is then available to the user. The user will get technique correcting advice via push notifications as well as by accessing the mobile application directly. The healthcare professional can look at the data to determine where more education can be given and tailor treatment to the individual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10-18,
- •diagnosis of asthma by the pediatrician,
- •regular access to a smartphone,
- •parental consent,
- •ongoing need for regular use of a medication delivered by metered dose inhaler as deemed by the pediatrician,
- •ability to demonstrate proper technique of metered dose inhaler use in the clinic while supervised by Asthma Nurse or pediatrician without parent or caregiver intervention
排除标准
- •Children 9 or under.
- •Individuals not using a metered dose inhaler.
- •Individuals without a smartphone.
- •Individuals taking part in another drug/device study at this time
- •Individuals who have finished another drug/device study in the last 30 days
结局指标
主要结局
Does the given mobile health intervention improve inhaler technique in children aged 10-18?
时间窗: 3-6 Months
Detailed outcome measures include: To compare the metered dose inhaler technique before and after use of BreatheSuite.This device attaches to metered dose inhalers and it can determine if: 1. the dose was given, 2. the metered dose inhaler was properly shaken, 3. the metered dose inhaler is properly aligned, and 4. the flow of medication is appropriate. 5. there is no accidental exhalation into the inhaler. Similar to that done of a study by Ronmark et al, inhaler technique scores are computed from 0-100%, with each of the five technique steps mentioned above are given one of three values: 20 (Perfect Score for Technique Step), 10 (partially correct step) or 0 (not correct at all). Thus, the technique scores are varied from 0-100 in increments of 10.
次要结局
- To compare the Asthma Control Questionnaire scores before and after use of BreathSuite(3-6 months)
研究者
Mary Jane Smith
Assistant Professor of Pediatrics
Memorial University of Newfoundland