Automating Patient Inhaler Technique When Using Pressurised Metered Dose Inhalers: Testing the Functionality and Impact of the Aflo™ Digital Respiratory Management Platform in a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Inhaler Proficiency checklist Score (IPS)
研究概览
简要总结
This randomised, prospective, controlled parallel study aims to evaluate the role and potential of the aflo™ digital platform for improving asthma control, inhalation technique and adherence in patients who use metred dose inhalers (MDI). The study will recruit 104 patients with uncontrolled asthma in the North-West of Northern Ireland. Fifty two patients will remain on standard care over 24-weeks and 52 will combine standard care with the aflo™ platform. The data collected over a 24-week period will be used to determine 1. whether the aflo™platform improves inhalation technique and user adherence to prescribed medication and 2. Lead to better asthma control and reduced symptoms as measured by the Asthma Control Test (ACT). During the study clinicians will be able to remotely monitor and review user analytics via a clinical dashboard. ACT measurements will be recorded at start and end of study. The study aims to test the functionality and impact of automated inhaler technique with real-time feedback, adherence prompts and air quality data sharing for patients who use metered dose inhalers (MDI) using the newly developed aflo™ digital respiratory management platform.
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
- None
盲法说明
Independent allocation, no masking.
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed as suitable for inclusion by their General Practitioner or asthma nurse.
- •Access to WiFi and a smart phone (Android or apple phone with latest version -2) and knowledge of / carer support with using a smartphone.
- •For children (parent/ carer must register and provide smart phone access)
- •Aged > 5 years (with carer/ parental consent if < 17 years old)
- •Smart phone user/ willing to use (or parent/ carer) and have access to and knowledge of working a smart phone and WIFI / 4G
- •Currently prescribed an inhaled reliever +/- preventer medication via pressurised
- •Metered Dose Inhaler (MDI) short acting beta2 agonist (SABA), inhaled corticosteroid (ICS) ICS / long acting beta2 agonist (LABA) MDI +/- spacer
- •Adherence/ symptom control issues with medication (as identified by excess use of SABA/ healthcare personnel visits/ calls/ emergency department visit/ hospital admission
- •Those who understand written and spoken English
排除标准
- •< 5 years old
- •Other major respiratory illness or significant concurrent disease that might prevent completion of the study
结局指标
主要结局
Inhaler Proficiency checklist Score (IPS)
时间窗: Change over 24 weeks
Inhalation score 0-7 (higher the score the greater the proficiency)
次要结局
- Asthma health and symptoms questionnaire(Change over 24 weeks)
- Medication usage(Change over 24 weeks)
- Health impairment in asthma patients(Change over 24 weeks)
- Exhaled breath nitric oxide (FeNO)(Change over 24 weeks)
- Asthma control(Change over 24 weeks)
- Lung function(Change over 24 weeks)
- Inflammation(Change over 24 weeks)