A Randomized, Controlled, Clinical Trial to Address the Burden of Undiagnosed Airflow Obstruction in Canadian Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 508
- 试验地点
- 15
- 主要终点
- Annual rate of patient initiated healthcare utilization events for respiratory illness
研究概览
简要总结
Previous population health studies suggest that up to 10% of Canadian adults have undiagnosed asthma or COPD- these people are currently undiagnosed and untreated, even though they may have significant respiratory symptoms. Our study will use targeted casefinding to find people with undiagnosed asthma and COPD in Canadian communities. The investigators will assess their symptoms and their health care use and number of sick days to determine the burden of undiagnosed respiratory disease in these people. The investigators will then determine whether early treatment of previously undiagnosed airflow obstruction will improve patients' health outcomes.
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 (Outcomes Assessor)
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
- •Subjects at least 18 years old;
- •Subjects who score > or = to 6 points on The Asthma Screening Questionnaire or > 19.5 points on The COPD Diagnostic Questionnaire;
- •Subjects who have given written informed consent to participate in this trial in accordance with local regulations;
- •Subjects able to perform pre and post bronchodilator spirometry to measure lung function;
- •Additional Inclusion Criteria for RCT:
- •Those subjects who have undiagnosed airflow obstruction (i.e. Asthma will be diagnosed in subjects with airflow obstruction whose FEV1 improves by > 12% and 200 ml after bronchodilator and COPD will be diagnosed in subjects who do not have a significant bronchodilator response and who exhibit persistent airflow obstruction post bronchodilator) will be asked to consent and participate in the RCT.
排除标准
- •Subjects who report a previous physician diagnosis of asthma.
- •Subjects who report a previous physician diagnosis of COPD
- •Subjects with any of the following conditions within the past 3 months: Heart attack or hospitalization for other heart problems; Stroke; Aortic or cerebral aneurysm; Detached retina or eye surgery
- •Subjects who are in the third trimester of pregnancy
- •Subjects involved in another interventional trial
研究组 & 干预措施
Enhanced Care
Treatment strategy using evidence-based guidelines for asthma or COPD
干预措施: Treatment strategy using evidence-based guidelines for asthma or COPD (Drug)
Enhanced Care
Treatment strategy using evidence-based guidelines for asthma or COPD
干预措施: Smoking Cessation (Behavioral)
Enhanced Care
Treatment strategy using evidence-based guidelines for asthma or COPD
干预措施: Participant Education (Behavioral)
Standard of Care
Spirometry result sent to family MD
干预措施: Smoking Cessation (Behavioral)
结局指标
主要结局
Annual rate of patient initiated healthcare utilization events for respiratory illness
时间窗: 12 months
Number of visits for respiratory illnesses divided by the length of time in the study
次要结局
- Changes in forced expiratory volume in one second (FEV1) measured in litres (L) using pre bronchodilator spirometry testing and post bronchodilator spirometry testing.(12 months)
- Quality of life changes as assessed by the 36-Item Short Form Health Survey (SF-36) Health Survey Questionnaire(12 months)
- Changes in overall respiratory symptoms (including cough, sputum and dyspnea) will be assessed using the COPD Assessment Test (CAT)(12 months)
- Change in disease-specific quality of life quantified using the St. George's Respiratory Questionnaire (SGRQ).(12 months)
- Smoking cessation rate(12 months)