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临床试验/NCT02343055
NCT02343055已完成不适用

Collaborative Self-Management Patient Education Will Improve Health Outcomes in COPD

Lawson Health Research Institute8 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2011年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
8
主要终点
COPD Assessment Test (CAT)

研究概览

简要总结

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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研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Usual Care

Placebo Comparator

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.

干预措施: Case Management and Self-Management Education (Other)

Case Management and Self-Management Education

Experimental

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.

干预措施: Case Management and Self-Management Education (Other)

结局指标

主要结局

COPD Assessment Test (CAT)

时间窗: 1 Year

COPD related quality of life measure in primary care.

次要结局

  • Health Care Utilization for Emergency Department visits proportion and rate per year(1 year)
  • Health Care Utilization for Hospital Admission proportion and rate per year(1 year)
  • Severe Exacerbation proportion and rate per year(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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