慢病管理智能化系统的开发与应用

注册号:

Registration number:

ChiCTR1800019799 

最近更新日期:

Date of Last Refreshed on:

2018-11-29 07:44:31 

注册时间:

Date of Registration:

2018-11-29 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

慢病管理智能化系统的开发与应用

Public title:

Development and application of intelligent management system for chronic disease

注册题目简写:

English Acronym:

研究课题的正式科学名称:

慢病管理智能化系统的开发与应用

Scientific title:

Development and application of intelligent management system for chronic disease

研究课题代号(代码):

Study subject ID:

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:

黄雨晴 

研究负责人:

陈纪言 

Applicant:

HUANG Yu-qing 

Study leader:

CHEN Ji-yan 

申请注册联系人电话:

Applicant telephone:

+86 13172054256

研究负责人电话:

Study leader's
telephone:

+86 20 83827812

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:

hyq513@126.com

研究负责人电子邮件:

Study leader's E-mail:

Chen-jiyan@163.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:

广东省广州市越秀区中山二路106号

研究负责人通讯地址:

广东省广州市越秀区中山二路106号

Applicant address:

106 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address:

106 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

广东省人民医院

Applicant's institution:

Guangdong General Hospital

研究负责人所在单位:

广东省人民医院

Affiliation of the Leader:

Guangdong General Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

No.GDREC2018290H(R1)

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:

广东省人民医院

Name of the ethic committee:

Guangdong General Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-10 00:00:00

伦理委员会联系人:

蒋发烨

Contact Name of the ethic committee:

JIANG Fa yue

伦理委员会联系地址:

广东省广州市越秀区中山二路106号

Contact Address of the ethic committee:

106 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

广东省人民医院

Primary sponsor:

Guangdong General Hospital

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路106号

Primary sponsor's address:

106 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

广 州 市 科 技 计 划 项 目

Source(s) of funding:

Guangzhou Science and Technology Plan Project

研究疾病:

慢性疾病  

Target disease:

Chronic disease

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

研发慢性疾病智能化管理系统并建立基于互联网技术和平台的心脑血管风险预警  

Objectives of Study:

Develop an intelligent management system for chronic diseases and establish a wake-up of cardiovascular and cerebrovascular risks based on Internet technologies and platforms.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

不签同意书,不配合随访,预期寿命小于1年

Exclusion criteria:

Do not sign the consent form, do not cooperate with the follow-up, the life expectancy is less than 1 year

研究实施时间:

Study execute time:

From 2018-12-01 00:00:00 To 2021-12-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2018-12-01 00:00:00 To 1990-01-01 00:00:00

干预措施:

Interventions:

组别:

Case series

样本量:

10000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

广东省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong general hospital

Level of the institution:

Tertiary A Hospital

国家:

中国

省(直辖市):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

黄石街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Huangshi Street Community Health Service Center

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

均禾街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Junhe Street Community Health Service Center

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

京溪街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Jingxi Street Community Health Service Center

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

棠下街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Tangxia Street Community Health Service Center

Level of the institution:

Community Health Service Center

测量指标:

Outcomes:

指标中文名:

慢病问卷

指标类型:

主要指标

Outcome:

Chronic questionnaire

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠问卷

指标类型:

次要指标

Outcome:

Sleep questionnaire

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易精神量表

指标类型:

次要指标

Outcome:

Simple mental scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

主要指标

Outcome:

lipid

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标

Outcome:

blood sugar

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

主要指标

Outcome:

Creatinine

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

电解质

指标类型:

主要指标

Outcome:

Electrolyte

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿酸

指标类型:

主要指标

Outcome:

Uric acid

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CRP

指标类型:

主要指标

Outcome:

CRP

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

主要指标

Outcome:

Blood routine

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

握力

指标类型:

次要指标

Outcome:

Grip

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全因死亡

指标类型:

主要指标

Outcome:

All cause death

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心脑血管事件

指标类型:

主要指标

Outcome:

Heart and cerebrovascular events

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

因病住院事件

指标类型:

次要指标

Outcome:

Hospitalization due to illness

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

次要指标

Outcome:

Glycated hemoglobin

Type:

Secondary 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:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存  

说明

Fate of sample:

Preservation after use  

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

非随机

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

no randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

文章出版

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

papers

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:

EDC

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

EDC

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-11-29 07:44:31