Optimisation of ASthma In Those With Uncontrolled Symptoms (OASIS) in Primary Care Using a Digital Consultation Tool During the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Rate of exacerbation frequency
研究概览
简要总结
A digital tool, called ReferID has been developed to facilitate the review of asthma patients. It aims to assist in the identification of patients with uncontrolled and/or severe asthma and to ensure a timely referral to secondary care where appropriate. To validate the tool, patients will be randomised to have a review with a healthcare professional using tool to facilitate the review or to continue receiving usual care. Outcome measures including exacerbation frequency and level of asthma control will be assessed at 12 months.
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 (Care Provider)
盲法说明
An electronic randomisation programme will be used to assign the patient to each arm of the study in primary care. However during the review, masking will not be possible.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All asthma patients with 1 of more exacerbations in the last 12 months or receiving high dose inhaled corticosteroids.
- •Patients able and willing to provide informed consent.
- •Patients aged 18 and over.
排除标准
- •Patients who lack capacity.
- •Patients who do not have a diagnosis of asthma
- •Patients who are unable to provide informed consent
- •Patients under the age of 18
- •Patients already under a severe asthma centre
结局指标
主要结局
Rate of exacerbation frequency
时间窗: 24 months
Measured by the number of courses of oral corticosteroids measured at 12 months before and 12 months after initial consultation. Exacerbations are defined as the need for oral corticosteroids prescribed by a healthcare professional for a minimum of 3 consecutive days in the context of worsening asthma symptoms.
次要结局
- Asthma control measured by the Asthma Control Questionnaire (ACQ) - 6.(12 months)
- Emergency care utilisation(24 months)
- Inhaler technique assessed.(12 months)
- Adherence to inhaled corticosteroids(24 months)
- Salbutamol use (measured by the number of inhalers issued)(24 months)
- Quality of Life Score measured by the mini Asthma Quality of Life Questionnaire (mAQLQ)(12 months)
- Number of patients referred to secondary care who are taking part in the study.(12 months)
- Number of patients initiated on biologic therapy(12 months)
- Number of patients who are found to have an incorrect diagnosis.(12 months)