Today is 2020-07-05

Research for the benefits and influencing factors of standardized management of chronic obstructive pulmonary disease
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注册号:

Registration number:

ChiCTR2000031092 

最近更新日期:

Date of Last Refreshed on:

2020-03-22 

注册时间:

Date of Registration:

2020-03-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

慢性阻塞肺疾病规范管理模式的建立和影响因素研究 

Public title:

Research for the benefits and influencing factors of standardized management of chronic obstructive pulmonary disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

慢性阻塞性肺疾病社区规范化管理及双向转诊的探讨 

Scientific title:

Two-way referral study and re-evaluation of health economics and standardization management of chrond 

研究课题代号(代码):

Study subject ID:

20124124 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

李凡 

研究负责人:

李凡 

Applicant:

Fan Li 

Study leader:

Fan Li 

申请注册联系人电话:

Applicant telephone:

+86 18918288118 

研究负责人电话:

Study leader's telephone:

+86 18918288118 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

lifanking@live.com 

研究负责人电子邮件:

Study leader's E-mail:

lifanking@live.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市松江区中山中路748号 

研究负责人通讯地址:

上海市松江区中山中路748号 

Applicant address:

748 Middle Zhongshan Road, Songjiang District, Shanghai, China 

Study leader's address:

748 Middle Zhongshan Road, Songjiang District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海市松江区中心医院 

Applicant's institution:

Songjiang District Central Hospital, Shanghai 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

201506-松中心 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海市松江区中心医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Shanghai Municipal Songjiang District Central Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-07-02 

伦理委员会联系人:

朱仲庚 

Contact Name of the ethic committee:

Zhonggeng Zhu 

伦理委员会联系地址:

上海市松江区中山中路748号 

Contact Address of the ethic committee:

748 Middle Zhongshan Road, Songjiang District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

上海市松江区中心医院 

Primary sponsor:

Songjiang District Central Hospital, Shanghai 

研究实施负责(组长)单位地址:

上海市松江区中山中路748号 

Primary sponsor's address:

748 Middle Zhongshan Road, Songjiang District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市松江区中心医院

具体地址:

松江区中山中路748号

Institution
hospital:

Songjiang District Central Hospital, Shanghai

Address:

748 Middle Zhongshan Road, Songjiang District

经费或物资来源:

上海市卫生局 

Source(s) of funding:

Shanghai Municipal Health Bureau 

研究疾病:

慢阻肺 

Target disease:

COPD 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1. 探讨在社区推广COPD防治指南,规范社区全科医生对COPD病人的防控的卫生经济学价值; 2. 建立一个慢阻肺分级诊疗移动互联网管理系统。 3. 建立一个慢阻肺患者自我管理的平台。 

Objectives of Study:

1. To study impact of adherence to GOLD guidelines on health economic value in a Shanghai suburb; 2. Develop Smartphone-based D2P-COPD Platform in the Hierarchical Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease; 3. Develop a mobile Internet information system for self-management of COPD patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

成年COPD患者,符合2011年COPD诊治指南诊断标准。 

Inclusion criteria

Patients meet the diagnostic criteria adherence to GOLD 2011. 

排除标准:

1、合并有其他严重心、肝、肾、脑等并发症; 2、语言表达能力太差; 3、不能完成全部研究过程者; 4、合并有恶性肿瘤者。 

Exclusion criteria:

1. severe heart, liver, kidney, or brain disease; 2. Poor language skills; 3. Inability to complete the study; 4. Combined with malignant tumor. 

研究实施时间:

Study execute time:

From2020-02-01To 2023-12-30 

干预措施:

Interventions:

组别:

规范化组(遵循指南治疗)

样本量:

1000

Group:

Standardized set of adherence to GOLD guidelines

Sample size:

干预措施:

遵循指南治疗

干预措施代码:

Intervention:

Follow the guidelines

Intervention code:

组别:

非规范组(未执行指南)

样本量:

1000

Group:

Non-normative group (guidelines not implemented)

Sample size:

干预措施:

干预措施代码:

Intervention:

No intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

松江 

Country:

China 

Province:

Shanghai 

City:

Songjiang District 

单位(医院):

上海市松江区中心医院 

单位级别:

二级甲等 

Institution
hospital:

Songjiang District Central Hospital, Shanghai  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

慢阻肺评估测试表

指标类型:

主要指标 

Outcome:

CAT

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

呼吸困难问卷

指标类型:

主要指标 

Outcome:

mMRC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院次数

指标类型:

主要指标 

Outcome:

Number of hospitalizations

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

急诊次数

指标类型:

主要指标 

Outcome:

Emergency number

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命质量

指标类型:

主要指标 

Outcome:

Quality of Life

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗率

指标类型:

主要指标 

Outcome:

Rate of Treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗规范化率

指标类型:

主要指标 

Outcome:

The rate of standardized pharmacologic treatment

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 90 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

N/A

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

不适用

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

论文发表后,通过ResMan网站公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

After the paper was published, the data will be published on the ResMan website after the trial is completed

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

数据由第一研究单位保存,建立了专门数据库。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

The data is save by first research unit, and set up a specialist database.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-22
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