健康教育对关节炎患者治疗依从性和生活质量影响的研究

注册号:

Registration number:

ChiCTR-OCC-10001120 

最近更新日期:

Date of Last Refreshed on:

2015-07-04 13:56:25 

注册时间:

Date of Registration:

2010-12-11 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

健康教育对关节炎患者治疗依从性和生活质量影响的研究

Public title:

Study of effect of health education on treatment compliance and quality of life in arthritis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

沙利度胺抗RA血管新生治疗的基础和临床研究

Scientific title:

study of the basis and clinical effect of antiangiogenesis of thalidomide in RA

研究课题代号(代码):

Study subject ID:

BS2005037

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:

廖月霞 

研究负责人:

张育 

Applicant:

Yue-xia LIAO 

Study leader:

Yu ZHANG 

申请注册联系人电话:

Applicant telephone:

+86 0514-87978842

研究负责人电话:

Study leader's
telephone:

+86 0514-87978805

申请注册联系人传真 :

Applicant Fax:

+86 0514-87341733

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:

liaoyx_76@163.com

研究负责人电子邮件:

Study leader's E-mail:

yzzy10182001@yahoo.com.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:

扬州大学医学院88#信箱

研究负责人通讯地址:

扬州大学医学院

Applicant address:

Medical College of Yangzhou University, Yangzhou, Jiangsu

Study leader's address:

Medical College of Yangzhou University, Yangzhou, Jiangsu, China

申请注册联系人邮政编码:

Applicant postcode:

225009

研究负责人邮政编码:

Study leader's postcode:

225009

申请人所在单位:

扬州大学医学院

Applicant's institution:

Medical College of Yangzhou University

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:

No

伦理委员会批件文号:

Approved No. of ethic committee:

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:

Name of the ethic committee:

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 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:

扬州大学医学院

Primary sponsor:

Medical College of Yangzhou University

研究实施负责(组长)单位地址:

扬州大学医学院88#信箱

Primary sponsor's address:

Medical College of Yangzhou University

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省科技厅

具体地址:

江苏省南京市北京东路39号

Institution
hospital:

Technological Department of Jiangsu Province

Address:

39 Beijing East Road, Nanjing, Jiangsu

经费或物资来源:

江苏省科技厅

Source(s) of funding:

Technological Department of Jiangsu

研究疾病:

关节炎  

Target disease:

arthritis

研究疾病代码:

M06.9

Target disease code:

M06.9

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

IV期临床试验 

Study phase:

4

研究设计:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

健康教育对关节炎患者治疗依从性和生活质量的影响  

Objectives of Study:

To investigate the effect of health education on treatment compliance and quality of life in arthritis

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:

精神、心理疾病史。

Exclusion criteria:

have a history of mental illness

研究实施时间:

Study execute time:

From 2006-01-01 00:00:00 To 2007-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2006-12-01 00:00:00 To 2007-11-30 00:00:00

干预措施:

Interventions:

组别:

A

样本量:

102

Group:

1

Sample size:

干预措施:

健康教育,健康手册

干预措施代码:

Intervention:

health education, Health Manual

Intervention code:

组别:

B

样本量:

130

Group:

2

Sample size:

干预措施:

问卷调查

干预措施代码:

Intervention:

Questionnaire survey

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):

苏北人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Subei people's hospital

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

生活质量

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:

治疗依从性

指标类型:

主要指标

Outcome:

compliance

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疾病活动指数

指标类型:

次要指标

Outcome:

BASD

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:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 16 years
最大 Max age 61 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):

方便选择

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

convenience enrollment

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

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):

扬州大学医学院

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

Medical College of Yangzhou University

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:

扬州大学医学院

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

Medical College of Yangzhou University

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2015-07-04 13:56:25