COPE With COPD Trial
2018年7月26日 更新者：Lawson Health Research Institute
Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD
The overall objective of this study is to evaluate a collaborative self-management intervention in patients with moderate to severe COPD in a primary care population. To achieve this objective the investigators developed a diagnostic and treatment pathway for the management of COPD in primary care that is based on national guidelines and focused on patient self-management.
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研究概览
研究类型
介入性
注册 (实际的)
182
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Amherstburg、Ontario、加拿大、N9V 0B4
- Amherstburg FHT
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Chatham、Ontario、加拿大、N7L 5K5
- Chatham-Kent FHT
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Harrow、Ontario、加拿大、NOR 1G0
- Harrow FHT
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Leamington、Ontario、加拿大、N8H 1N8
- Leamington FHT
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Current or Ex-smokers
- 40 years of age or over
- Minimum 10 pack year smoking history
- Post-bronchodilator FEV1 of 70% or less (4 puffs of Salbutamol) and Forced Expiratory Volume at 1sec to Forced Vital Capacity (FEV1/FVC) ratio 70% or less
- A history of two exacerbations (involving treatment and/or visit to a health care practitioner) in the past 3 years OR 1 exacerbation in the past year
- Provides informed consent
Exclusion Criteria:
- COPD exacerbation in the past 4 weeks
- Diagnosis of asthma prior to the age of 40 years
- Co-existing illness that could interfere with study results (ie. Congestive Heart Failure with exacerbation of symptoms)
- Scheduled for COPD rehabilitation
- A terminal illness
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Case Management and Self-Management Education
A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician.
Specific elements of evidence-based management are targetted for intervention.
Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months.
Telephone follow up will occur at a minimum at 6 and 9 months.
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A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician.
Specific elements of evidence-based management are targetted for intervention.
Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months.
Telephone follow up will occur at a minimum at 6 and 9 months.
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安慰剂比较：Usual Care
A Certified Respiratory Educator (CRE) will meet with subjects to obtain a detailed COPD history and do a breathing test.
Subjects will receive COPD care as usually provided by their physician.
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A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician.
Specific elements of evidence-based management are targetted for intervention.
Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months.
Telephone follow up will occur at a minimum at 6 and 9 months.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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COPD Assessment Test (CAT)
大体时间：1 Year
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COPD related quality of life measure in primary care.
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1 Year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Health Care Utilization for Emergency Department visits proportion and rate per year
大体时间：1 year
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The proportion of subjects that utilized the Emergency for a COPD exacerbation
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1 year
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Health Care Utilization for Hospital Admission proportion and rate per year
大体时间：1 year
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The proportion of subjects that were admitted to hospital for a COPD exacerbation An exacerbation is defined as an increase in or the onset of more than one respiratory symptom (cough, sputum, sputum purulence, wheezing, or dyspnea) lasting 3 days or more and requiring treatment with an antibiotic or a systemic corticosteroid.
Respiratory status had to return to baseline for at least 72 hours before another exacerbation would be counted.
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1 year
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Severe Exacerbation proportion and rate per year
大体时间：1 year
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The proportion of subjects experiencing one or more exacerbations in the study interval.
An exacerbation diary will be completed for each event.
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1 year
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Life
大体时间：1 year
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Improvement of Quality of Life using the CAT score(COPD Assessment Test)
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1 year
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Improvement in Knowledge of COPD and confidence in self-management
大体时间：1 year
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Improvement in Bristol COPD Knowledge Questionnaire and patient self report
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1 year
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Process of Care
大体时间：1 year
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Process of care: have written action plan, used action plan, advised to quit smoking, offered pharmacologic help with quitting, quit smoking, current packs/day, diagnosis confirmed by spirometry, vaccination rates, instructed on inhaler technique, vaccination rates
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1 year
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Dyspnea Improvement
大体时间：1 year
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Change in dyspnea using the modified MRC questionnaire - Medical Research Council (MRC).
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1 year
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Disease control
大体时间：1 year
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Disease control using the Clinical COPD questionnaire (CCQ)
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1 year
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Symptom Profile
大体时间：1 year
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Change in Symptom profile (cough, wheeze, sputum production)
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1 year
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Forced Expiratory Volume at 1sec (FEV1) % predicted
大体时间：1 year
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FEV1
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1 year
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Proportion of Patients on therapy appropriate to their stage of disease
大体时间：1 year
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Evaluate medication prescribed related to stage of disease
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1 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christopher Licskai、Lawson Health Research Institution
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年10月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2015年1月1日
研究注册日期
首次提交
2014年10月22日
首先提交符合 QC 标准的
2015年1月20日
首次发布 (估计)
2015年1月21日
研究记录更新
最后更新发布 (实际的)
2018年7月30日
上次提交的符合 QC 标准的更新
2018年7月26日
最后验证
2015年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 00000941
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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