The Use of Home-monitoring and mHealth Systems to Predict Asthma Control and the Occurrence of Asthma Exacerbations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Asthma control using the asthma control diary
研究概览
简要总结
The investigators will collect a range of physiological, behavioural and environmental data using current mHealth and home-monitoring systems, environmental databases and patient characteristics, to determine to what extent asthma control and the occurrence of asthma exacerbations can be predicted.
详细描述
This observational study occurs alongside participants' normal asthma care. Participants will be asked to attend their normal GP and hospital appointments, and to continue to take their medication as determined by their usual healthcare team.
In addition to their normal care, participants will attend an induction visit and complete a 12-month home-monitoring period with 2 phases:
- Phase 1: one-month period of daily monitoring of asthma
- Phase 2: eleven-month period of weekly monitoring of asthma. Patients will be invited for a further 2-week period of daily monitoring between 2-9 months of Phase 2. The purpose of the second phase of daily monitoring is to assess the influence of seasonality (different seasons) on the patient's asthma.
0 xxxx 1 ------ 2 ------ 3 ------ 4 yy-- 5 ------ 6------ 7 ------ 8 ------ 9 ------ 10 ------ 11 ----- 12
Figure 1. Schematic of study design. 0 1 2.., months; xxxx, first series of 4 weeks daily monitoring; ------ 11 months weekly monitoring; yy--, example of second series of 2 weeks daily monitoring during month 5 (the timing of this 2 weekly phase will be randomised over month 2-9).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Doctors-diagnosis of asthma with confirmation of asthma from one or more of the following tests in medical notes:
- •i) Reversibility of 12% and 200ml in a spirometry following administration of a bronchodilator medication ii) Peak flow monitoring for one week iii) Positive bronchial challenge
- •BTS asthma treatment step 2-4, for a minimum of 6 months in the previous year
- •A course of oral prednisone for a minimum of three days, or an emergency department visit/hospitalisation for asthma, in the previous twelve months. Or currently experiencing uncontrolled asthma (based on the result of the Asthma Control Questionnaire)
排除标准
- •Comorbidities that cause overlapping symptoms such as breathlessness, wheeze, cough or other interfering chronic condition (for example other symptomatic chronic respiratory disease, cardiac failure etc.).
- •Unable to understand English or Dutch, as appropriate
结局指标
主要结局
Asthma control using the asthma control diary
时间窗: After 1 month
A score of 0.0-0.75 is classified as well-controlled asthma; 0.75-1.5 as a partly controlled; and \>1.5 as poorly controlled asthma.
Moderate asthma exacerbations
时间窗: 1 year & preliminary analysis after 1 month
A moderate asthma exacerbation is an event that, when recognized, should result in a temporary change in treatment, in an effort to prevent the exacerbation from becoming severe. Moderate asthma exacerbations are defined by occurrence of at least one or more of the following: * deterioration in symptoms, * deterioration in lung function, * and increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization. ER visits for asthma (e.g., for routine sick care), not requiring systemic corticosteroids, are also classified as moderate exacerbations
Severe asthma exacerbations
时间窗: 1 year & preliminary analysis after 1 month
Severe asthma exacerbations are events that require urgent action on the part of the patient and physician to prevent a serious outcome, such as hospitalization or death from asthma. The occurrence of severe asthma exacerbations is an important marker of poor asthma control. Severe asthma exacerbations are defined by the occurrence of at least one of the following: * Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days. For consistency, courses of corticosteroids separated by 1 week or more should be treated as separate severe exacerbations. * A hospitalisation or ER visit because of asthma, requiring systemic corticosteroids.
次要结局
- Asthma Control using asthma control questionnaire(1 year)
- User acceptence(1 year & preliminary analysis after 1 month)