A 2 Arm, Multi-centre, Open Label, Parallel-group Randomised Designed Trial Investigating the Use of Sputum Colour Charts to Guide Antibiotic Self-treatment of Acute Exacerbation of COPD in Patients With COPD - Colour COPD
试验速览
- 阶段
- 不适用
- 入组人数
- 2,954
- 试验地点
- 1
- 主要终点
- Number of hospital admissions where the primary reason for admission is AECOPD
研究概览
简要总结
The primary objective of this study is to determine if a sputum colour chart can aid patient self-management of COPD exacerbations, such that use of the chart is non-inferior to usual care with respect to hospital admissions. There are also a range of other secondary objectives as detailed in the secondary outcomes section. An integral pilot phase, economic evaluation and process evaluation are also included.
详细描述
This study is a pragmatic, individually randomized trial, set in primary care, comparing usual care to the use of a sputum colour chart in patients at risk of hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD), with the hypothesis that use of a colour chart will be non-inferior to usual care with respect to hospital admission rate after 12 months of follow-up, this being the primary outcome measure. Use of a chart might reduce antibiotic use, and thus might also change patterns of antibiotic resistance long term, such that these are important secondary outcomes. There is an internal pilot phase, a detailed process evaluation and a cost-effectiveness study.
The trial protocol also includes three sub-studies: 1) using a daily electronic symptom diary capable of picking up symptom defined (but potentially unreported) AECOPD, since these are an important prognostic marker (section 3); 2) collecting sputum samples from patients to assess patterns of antibiotic resistance and 3) a qualitative study which will include staff (for example, healthcare staff delivering the intervention) and patients.
This trial uses a sputum colour chart as part of a self-management intervention that enables patients with COPD to determine whether they have an exacerbation, and whether this requires antibiotic treatment. The 5 point sputum colour chart, adapted from Bronkotest® is being used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Clinically diagnosed COPD, confirmed by a medical record of post-bronchodilator spirometry denoting obstruction.
- •≥2 AECOPD in the 12 months prior to screening according to the patient or ≥1 hospital admission for AECOPD (i.e. Global Initiative for Chronic Obstructive Lung Disease- GOLD; C or D).
- •Able to safely use SM plan in the view of their usual care practitioner
- •Able to use sputum colour chart; this will be confirmed by a sight test if there is any doubt on initial assessment by the usual care or research team. Patients who report being colour blind will have their ability to use the chart tested at the screening visit.
- •Written Informed consent given
- •Additionally, to participate in the E-diary sub-study. - Access to smartphone/tablet and an email address.
- •Additionally, to participate in the Sputum sub-study.
- •Chronic bronchitis, defined by self-reported sputum production for at least 3 months in each of 2 consecutive years or more.
排除标准
- •Household member already participating in the study.
结局指标
主要结局
Number of hospital admissions where the primary reason for admission is AECOPD
时间窗: 12 months post randomisation
A binary outcome assessing incidence of at least one AECOPD over 12 months after randomisation where patients needed hospitalisation (defined by hospital discharge letter/coding).
次要结局
- Number of prescriptions for 2nd courses of antibiotics within 14 days of self-reported event (defined as treatment failure)(12 months post randomisation)
- Number of Bed days due to AECOPD(12 months post randomisation)
- Number of participant deaths from all causes(12 months post randomisation)
- Number of unscheduled GP visits for AECOPD(12 months post randomisation)
- Number of self-reported AECOPD every 3 months(3, 6, 9 and 12 months post randomisation)
- Number of all cause hospital admissions(12 months post randomisation)
- Number of readmissions to hospital for AECOPD at 30 and 90 days(12 months post randomisation)
- Quality of life by COPD assessment test(3, 6, 9 and 12 months post randomisation)
- Quality of life measured using the EuroQoL-5Dimension-5Level questionnaire(3, 6, 9 and 12 months post randomisation)
- Healthcare resource utilisation(3, 6 and 9 and 12 months post randomisation)
- Number of prescriptions for oral anti-fungals(12 months post randomisation)
- Number of Self-reported antibiotic and steroid prescriptions for AECOPD(3, 6, 9 and 12 months post randomisation)
- Antibiotic resistance(at baseline, all AECOPD and 12 months post randomisation)