Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients (ACDM-Maccabi)
Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
研究概览
详细说明
The aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma. The intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the Jerusalem and the Lowland District of Maccabi Health Services in Israel.
The main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease.
Secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Bat-Yam、以色列
- Maccabi Pulmonary Clinic
-
Holon、以色列
- Maccabi Pulmonary Clinic
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women
- 40 years or older
- Having unstable COPD or Asthma
Exclusion Criteria:
- Significant LV dysfunction
- Other severe chronic morbidity compromising short-term survival
- Significant cognitive impairment or psychiatric disease
- Bedridden
- Homeless or no telephone connection
学习计划
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 |
|---|---|
|
实验性的：Disease Management
Comprehensive care delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals in the community
|
Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
|
|
有源比较器：Unual care
Care delivered by the primary practitioner with the advice of a consultant pulmonologist
|
Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
|
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 |
|---|---|---|
|
Healthcare services utilization for acute exacerbations of pulmonary disease
大体时间：Every 6 months during 1-3 years' follow-up
|
The proportion of patients who, due to exacerbation of their COPD or asthma, have at least one out of hours visit to a "off-hour non-hospital based acute-care facilities", or a visit to a hospital emergency room, or a hospitalization within the two years of follow-up.
|
Every 6 months during 1-3 years' follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life
大体时间：Every 6 months during 1-3 years' follow-up
|
Health-related quality of life
|
Every 6 months during 1-3 years' follow-up
|
|
Pulmonary function tests
大体时间：Every 6 months during 1-3 years' follow-up
|
Pulmonary function tests
|
Every 6 months during 1-3 years' follow-up
|
|
Physical function
大体时间：Every 6 months during 1-3 years' follow-up
|
6-minutes walk test assessment
|
Every 6 months during 1-3 years' follow-up
|
|
Depression
大体时间：Every 6 months during 1-3 years' follow-up
|
PHQ-9 Questionnaire
|
Every 6 months during 1-3 years' follow-up
|
合作者和调查者
调查人员
- 首席研究员：Meir Raz, M.D.、Maccabi Healthcare Services, Israel
- 研究主任：Ofra Kalter - Leibovici, M.D.、Sheba medical center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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