Sputum-guided Treatment With Comprehensive Care Management for Respiratory Improvement to Provide Value and Escalate Care - A Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Severe exacerbations of COPD
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a lung condition affecting 1 in 6 Canadians and does not have a cure. Flare-ups of COPD are the most common reason someone goes to hospital in Canada. This is made worse because within 30-days of having a flare-up, 1 in 5 patients will come back to hospital for the same problem.
Flare-ups of COPD often have many causes and these are different person to person. Sometimes it is related to behaviours such as smoking or not using medicines properly. Other times, it is from lung inflammation. Education programs that help people learn about their disease and maintain healthy behaviours, and using phlegm to decide on which medicines will be useful, have been studied separately and appear to work, but many people still have flare-ups. To help fix this problem, we need to look carefully at each patient, to make sure they are on the right medicine but also have the right behaviours and support to benefit from medical care.
The goal of this project is to see if patients who are taught the right behaviours and have their lung inflammation controlled with the right medicines will have fewer COPD flare-ups than those who get normal care.
详细描述
STRIVE is a randomized-controlled trial comparing a two-pronged intervention, including sputum-biomarker-directed treatment of airway inflammation, and comprehensive care management, to usual care, for COPD patients with frequent exacerbation from two sites.
The intervention consists of 6-months of comprehensive care management (CCM) and sputum biomarker-directed treatment of airway inflammation, including hospital and clinic visits. Clinic visits will occur at 2, 6 and 16 weeks after hospital discharge. For the intervention group, the key elements of CCM will be provided, including case management, self-management education, and coordination of community/hospital resources (1). Spontaneous sputum biomarkers will be used to direct therapy at the time of AECOPD and during clinic visits after hospital discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Study personnel (aside from the research coordinator) will be blinded to randomization, sputum biomarker results, and treatment arm. Sputum biomarker results (de-identified) will be available to site leads to optimize treatment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=2 exacerbations of COPD in the last 12-months, FEV1/FVC<0.7 or radiologic emphysema, with a >-10 pack-year smoking history
排除标准
- •severe mental illness not controlled by medication or life-expectancy less than 6-months
结局指标
主要结局
Severe exacerbations of COPD
时间窗: 6 months
As defined by an acute worsening of respiratory symptoms requiring treatment with antibiotics or steroids associated with ER visit or hospitalization.
次要结局
- Reason for non-participation(2 years)
- Change in Clinical COPD Questionnaire(26 weeks)
- Patient care(study duration)
- FEV1(16 weeks)
- Sputum abnormalities rectified(16 weeks)
- Change in COPD Assessment Test(26 weeks)
- Use of antibiotics(6 months)
- Number of days to visit 1(Should fall within a 2-3 week window)
- Time to first COPD exacerbation(6 months)
- Change in Patient Health Questionnaire-9(26 weeks)
- EQ-5D-5L questionnaire(26 weeks)
- Sputum eosinophil percentage(16 weeks)
- Sputum neutrophil count(16 weeks)
- Moderate COPD Exacerbation(6 months)
- Mild COPD Exacerbation(6 months)
- COPD exacerbation associated with inflammation(6 months)
- Time to first COPD exacerbation associated with inflammation(6 months)
- Use of oral or inhaled corticosteroid(6 months)
- Change in General Anxiety Disorder-7 questionnaire(26 weeks)
- Number of clinic visits(6 months)
- Side effects(26 weeks)
- Participant recruitment number(2 years)
- Clinic attendance(6 months)