2型糖尿病患者对运动干预的认知程度调查

注册号:

Registration number:

ChiCTR-OB-11001562 

最近更新日期:

Date of Last Refreshed on:

2015-07-20 22:11:01 

注册时间:

Date of Registration:

2011-09-25 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

2型糖尿病患者对运动干预的认知程度调查

Public title:

A survey of patients with type 2 diabetes exercise intervention on awareness

注册题目简写:

English Acronym:

研究课题的正式科学名称:

2型糖尿病患者对运动干预的认知程度调查

Scientific title:

A survey patients with type 2 diabetes exercise intervention on awareness

研究课题代号(代码):

Study subject ID:

2011LY02

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:

周嘉琪 

研究负责人:

吴云川 

Applicant:

Zhou Jiaqi 

Study leader:

Wu Yunchuan 

申请注册联系人电话:

Applicant telephone:

+86 13675149805

研究负责人电话:

Study leader's
telephone:

+86 13913988723

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:

zjq668@163.com

研究负责人电子邮件:

Study leader's E-mail:

njwych@126.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:

江苏省南京市鼓楼区汉中门282号

研究负责人通讯地址:

江苏省南京市鼓楼区汉中门282号

Applicant address:

282 Hanzhong Road, Nanjing, Jiangsu, China

Study leader's address:

282 Hanzhong Road, Nanjing, Jiangsu, China

申请注册联系人邮政编码:

Applicant postcode:

210000

研究负责人邮政编码:

Study leader's postcode:

210000

申请人所在单位:

南京中医药大学第二临床医学院

Applicant's institution:

The Second School of Clinical Medicine, Nanjing University of Traditional Chinese Medicine

研究负责人所在单位:

Affiliation of the Leader:

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:

ChiECRCT-2011035

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

中国注册临床试验伦理审查委员会

Name of the ethic committee:

China registered clinical trials ethical review committee

伦理委员会批准日期:

Date of approved by ethic committee:

1990-01-01 00:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

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:

南京中医药大学第二临床医学院

Primary sponsor:

The Second School of Clinical Medicine, Nanjing University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

江苏省南京市栖霞区仙林大道138号

Primary sponsor's address:

282 Hanzhong Road, Nanjing, Jiangsu, 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):

安徽

市(区县):

Country:

China

Province:

Anhui

City:

单位(医院):

安徽中医学院第一附属医院

具体地址:

Institution
hospital:

Address:

经费或物资来源:

安徽中医学院第一附属医院

Source(s) of funding:

First Affiliated Hospital of Anhui Medical College

研究疾病:

2型糖尿病  

Target disease:

T2DM

研究疾病代码:

A181

Target disease code:

A181

研究类型:

流行病学研究

Study type:

Epidemilogical research

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

了解2型糖尿病的患者对运动干预的认识和接受程度  

Objectives of Study:

Understanding of type 2 diabetes exercise intervention on awareness and acceptance

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.不符合2型糖尿病诊断标准。
2.无认知能力,不愿参与调查研究的患者。

Exclusion criteria:

1. Does not meet the diagnostic criteria for type 2 diabetes;
2. no cognitive abilities, patients unwilling to participate in research.

研究实施时间:

Study execute time:

From 2011-06-01 00:00:00 To 2011-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2011-06-01 00:00:00 To 2014-11-30 00:00:00

干预措施:

Interventions:

组别:

1

样本量:

3500

Group:

1

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):

江苏 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

苏省级机关医院、溧水县中医院 

单位级别:

二甲医院 

Institution
hospital:

Jiangsu provincial authorities Hospital, Lishui County Hospital

Level of the institution:

Secondary A Hospital

测量指标:

Outcomes:

指标中文名:

2型糖尿病患者对运动干预的认知程度和此疾病相关因素

指标类型:

主要指标

Outcome:

Patients with type 2 diabetes awareness and exercise intervention in this disease-related factors

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:

结束

/Completed

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):

NA

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

NA

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:

医生 是 调查有专门的调查员进行,统计数据则有与此调查过程不相干的专业统计人员进行。 调查员 是 统计人员 是

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

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):

南京中医药大学

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

Nanjing University of Traditional Chinese Medicine

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:

南京中医药大学

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

Nanjing University of Traditional Chinese Medicine

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2015-07-20 22:11:01