A Feasibility Study to Assess Novel Electronic Monitoring Devices (NEMD) for Monitoring Adherence in Children With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Themes Generated by Participants Regarding Usage of the Devices
研究概览
简要总结
This is a feasibility study to assess novel electronic monitoring devices for monitoring adherence in children with asthma who are on inhaled corticosteroids (ICS)
It is a mixed method (quantitative and qualitative) open label, pragmatic randomised feasibility study with two main aims:
- To assess the feasibility of 4 novel electronic monitoring devices in children aged 6-16 years with asthma, in terms of usability and acceptability by patients/ guardians and healthcare professionals (qualitative study)
- To evaluate the accuracy of these devices and assess whether they impact on asthma control (quantitative study).
The duration of study is 16 weeks.
详细描述
This was an open label, block randomised (10 in each block), mixed method (quantitative and qualitative) study to be conducted for a period of up to 16 weeks
Children aged between 6-16 years with asthma attending the paediatric respiratory difficult asthma clinic will be recruited into the study and randomly allocated to one of three arms using block randomisation matched for age and size of group. Children will be assigned to trial one of the following four NEMD's to be tested:
- Block 1 (10): Smart-inhaler Plus™ (Adherium, New Zealand)
• This measures inhalation usually flow sensors and is the next generation of a currently commercially available EMD 2. Block 2a (5) : Flo-Tone (Clement Clarke, UK) plus Rafi-tone, acoustic enabled Smartphone App (clin-e-cal, UK) for children aged 6 - 11 years • The Flo-Tone attaches to a Metered Dose Inhaler (MDI) and makes a sound when the inhaler is used correctly. Rafi-tone is a Smartphone App that detects the sound and activates a game The game is aimed at younger children and therefore children aged 6 - 11 years will be randomised to this block.
Block 2b (5) : Inhaler Compliance Assessment (INCA™) device (INCA, Ireland)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
Pragmatic randomization based on inhaled medication
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained from parents/guardian/adolescents and/or assent from the child.
- •Children aged between 6-16 years with a diagnosis of asthma attending the Royal Brompton and Harefield Difficult asthma clinic.
- •Children on inhaled cortico-steroids
- •Parents/ young person has a mobile phone which can download apps
- •Paediatric respiratory nurses working in the difficult asthma team at Royal Brompton Hospital.
排除标准
- •Unable to provide consent
- •As a result of medical interview, physical examination or screening investigation the physician responsible considers the child unfit for the study.
- •Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures
- •Children under the age of 6 years.
- •Children not on inhaled cortico-steroid
- •It is not anticipated that any children will be pregnant, however, if they are they will not be included in the study
结局指标
主要结局
Number of Themes Generated by Participants Regarding Usage of the Devices
时间窗: 16 weeks
The Primary outcome measure is largely qualitative and based on collective themes. As a result there are no numerical measurements that differ each of the devices. In terms of accuracy of each device adherence data was collected but differs for each device depending on its functionality
Acceptability Using Semi Structured Questionnaires in Focus Groups and Interviews
时间窗: 16 weeks
Number of participant interviewed in focus groups and interviews
次要结局
- Adherence to Inhaled Medication(16 weeks)