中国护士健康队列的建立与开展:一项基于网络的纵向研究

注册号:

Registration number:

ChiCTR2300072756 

最近更新日期:

Date of Last Refreshed on:

2023-08-18 17:21:19 

注册时间:

Date of Registration:

2023-06-25 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

中国护士健康队列的建立与开展:一项基于网络的纵向研究

Public title:

The establishment and development of the Chinese Nurses' health cohort: a longitudinal web-based study

注册题目简写:

中国护士健康队列

English Acronym:

The TARGET Nurses' health cohort

研究课题的正式科学名称:

中国护士健康队列的建立与开展:一项基于网络的纵向研究

Scientific title:

The establishment and development of the Chinese Nurses' health cohort: a longitudinal web-based study

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:

李黎 

研究负责人:

曹英娟 

Applicant:

Li Li 

Study leader:

Yingjuan Cao 

申请注册联系人电话:

Applicant telephone:

+86 185 6008 4568

研究负责人电话:

Study leader's
telephone:

+86 185 6008 2789

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:

l7776lili@163.com

研究负责人电子邮件:

Study leader's E-mail:

caoyj@sdu.edu.cn

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:

山东省济南市历下区文化西路107号

研究负责人通讯地址:

山东省济南市历下区文化西路107号

Applicant address:

107 Wenhua Road West, Lixia District, Jinan, Shandong

Study leader's address:

107 Wenhua Road West, Lixia District, Jinan, Shandong

申请注册联系人邮政编码:

Applicant postcode:

250012

研究负责人邮政编码:

Study leader's postcode:

250012

申请人所在单位:

山东大学齐鲁医院

Applicant's institution:

Qilu Hospital of Shandong University

研究负责人所在单位:

山东大学齐鲁医院

Affiliation of the Leader:

Qilu Hospital of Shandong University

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:

KYLL-202210-060-1

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:

山东大学齐鲁医院科研伦理委员会

Name of the ethic committee:

Ethnics Committee of Scientific Research of Shandong University Qilu Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2023-03-08 00:00:00

伦理委员会联系人:

卜丽娟

Contact Name of the ethic committee:

Lijuan Bu

伦理委员会联系地址:

山东省济南市历下区文化西路107号

Contact Address of the ethic committee:

107 Wenhua Road West, Lixia District, Jinan, Shandong

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 531 8216 9166

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:

山东大学齐鲁医院

Primary sponsor:

Qilu Hospital of Shandong University

研究实施负责(组长)单位地址:

山东省济南市历下区文化西路107号

Primary sponsor's address:

107 Wenhua Road West, Lixia District, Jinan, Shandong

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东大学齐鲁医院

具体地址:

山东省济南市历下区文化西路107号

Institution
hospital:

Qilu Hospital of Shandong University

Address:

107 Wenhua Road West, Lixia District, Jinan, Shandong

经费或物资来源:

自筹经费

Source(s) of funding:

Self-raised funds

研究疾病:

癌症与心血管疾病  

Target disease:

Cancer and cardiovascular 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:

探索性研究/预试验 

Study phase:

0

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

探讨我国护士工作相关压力,工作环境和生活方式对健康结局(疾病发生)的影响。通过长期随访观察,将多个暴露组与非暴露组的发病情况进行比较,寻找疾病相关危险因素,并验证病因假说,确定因果关联强度。阐明护士职业健康状况及患病率、发病率和长期变化趋势,包括全因死亡率和特定原因死亡率等。为健康干预提供循证证据,为进一步的有效计划和政策提供证据参考。  

Objectives of Study:

To assess and describe the health status of Chinese nurses, focusing on the impact of work-related stress, work environment, and lifestyle risk factors on the health of Chinese nurses.

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:

1.进修护士; 2.离职护士。

Exclusion criteria:

1. Resigned nurses; 2. Those who refuse to participate in the study.

研究实施时间:

Study execute time:

From 2023-07-01 00:00:00 To 2033-07-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-07-01 00:00:00 To 2033-07-01 00:00:00

干预措施:

Interventions:

组别:

护士

样本量:

79532

Group:

Nurses

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

山东 

市(区县):

济南 

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东大学齐鲁医院 

单位级别:

三甲 

Institution
hospital:

Qilu Hospital of Shandong University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

浙江 

市(区县):

绍兴 

Country:

China

Province:

Zhejiang

City:

Shaoxing

单位(医院):

绍兴市中心医院 

单位级别:

三乙 

Institution
hospital:

Shaoxing Central Hospital

Level of the institution:

Tertiary B

国家:

中国

省(直辖市):

浙江 

市(区县):

衢州 

Country:

China

Province:

Zhejiang

City:

Quzhou

单位(医院):

衢州市人民医院 

单位级别:

三甲 

Institution
hospital:

People's Hospital of Quzhou

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉市中心医院 

单位级别:

三甲 

Institution
hospital:

The Central Hospital of Wuhan

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

江西 

市(区县):

南昌 

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

南昌大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

The Second Affiliated Hospital of Nanchang Univerty

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

山东 

市(区县):

济南 

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东中医药大学附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

河北 

市(区县):

沧州 

Country:

China

Province:

Hebei

City:

Cangzhou

单位(医院):

沧州市中心医院 

单位级别:

三甲 

Institution
hospital:

Cangzhou Central Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

新疆 

市(区县):

疏勒 

Country:

China

Province:

Xinjiang

City:

Shule

单位(医院):

疏勒县人民医院 

单位级别:

二甲 

Institution
hospital:

Shule County People's Hospital

Level of the institution:

Secondary A

国家:

中国

省(直辖市):

河南 

市(区县):

安阳 

Country:

China

Province:

Henan

City:

Anyang

单位(医院):

安阳地区医院 

单位级别:

三甲 

Institution
hospital:

Anyang District Hospital

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

陕西 

市(区县):

清涧 

Country:

China

Province:

Shaanxi

City:

Qingjian

单位(医院):

清涧县人民医院 

单位级别:

二甲 

Institution
hospital:

Qingjian County People's Hospital

Level of the institution:

Secondary A

国家:

中国

省(直辖市):

山东 

市(区县):

济南 

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东省立第三医院 

单位级别:

三甲 

Institution
hospital:

Shandong Provincial Third Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

工作相关指标

指标类型:

主要指标

Outcome:

Work-related factors

Type:

Primary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

健康状况

指标类型:

主要指标

Outcome:

health status

Type:

Primary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

人格特质

指标类型:

次要指标

Outcome:

personality

Type:

Secondary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

指标中文名:

生活方式

指标类型:

次要指标

Outcome:

lifestyle

Type:

Secondary indicator

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

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 65 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):

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

None

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:

Blinding:

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

否No

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):

原始数据暂不共享

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

not shared

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:

数据采集采用病例记录表(Case Record Form, CRF)。数据管理采用电子数据管理系统。

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

Case Record Form (CRF) is used for data collection. Data review are performed by Electronic Data managing system.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2023-06-25 11:33:31