在中国农村地区构建基于家庭成员督导策略的高血压病人服务包

注册号:

Registration number:

ChiCTR-ONC-12001940 

最近更新日期:

Date of Last Refreshed on:

2015-08-03 12:43:26 

注册时间:

Date of Registration:

2012-01-27 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

在中国农村地区构建基于家庭成员督导策略的高血压病人服务包

Public title:

Development of a family member-based education package for patients with hypertension in rural China

注册题目简写:

English Acronym:

研究课题的正式科学名称:

在中国农村地区构建基于家庭成员督导策略的高血压病人服务包

Scientific title:

Development of a family member-based education package for patients with hypertension in rural China

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:

王建明 

研究负责人:

王建明 

Applicant:

Jianming Wang 

Study leader:

Jianming Wang 

申请注册联系人电话:

Applicant telephone:

+86 15996496360

研究负责人电话:

Study leader's
telephone:

+86 15996496360

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:

merry21st@yahoo.com.cn

研究负责人电子邮件:

Study leader's E-mail:

merry21st@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:

南京市汉中路140号

研究负责人通讯地址:

南京市汉中路140号

Applicant address:

140 Hanzhong Rd. Nanjing, Jiangsu, China

Study leader's address:

140 Hanzhong Rd. Nanjing, Jiangsu, China

申请注册联系人邮政编码:

Applicant postcode:

210029

研究负责人邮政编码:

Study leader's postcode:

210029

申请人所在单位:

南京医科大学公共卫生学院

Applicant's institution:

School of Public Health, Nanjing Medical 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:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2011-0929

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:

南京医科大学伦理委员会

Name of the ethic committee:

IRB of Nanjing Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2011-09-29 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:

南京医科大学公共卫生学院

Primary sponsor:

School of Public Health, Nanjing Medical University

研究实施负责(组长)单位地址:

南京市汉中路140号

Primary sponsor's address:

140 Hanzhong Rd. Nanjing, Jiangsu, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

美国中华医学会

具体地址:

北京朝阳区建国路79号华贸中心2号写字楼402室

Institution
hospital:

China Medical Board, USA

Address:

Room 402, Tower 2,China Central Place, No. 79, Jianguo Road,Chaoyang, Beijing, 100025

经费或物资来源:

美国中华医学会

Source(s) of funding:

China Medical Board, USA

研究疾病:

高血压  

Target disease:

Hypertension

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:

连续入组 

Study design:

Sequential 

研究目的:

探讨基于家庭成员督导策略以提高高血压治疗依从性和血压控制率的可行性  

Objectives of Study:

To develop a family member-based education package for patients with hypertension and to determine if the family member supervised therapy can improve treatment adherence and BP control

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.继发性高血压;(2)独住;(3)拒绝参加;(4)存在其它严重并发症

Exclusion criteria:

1. Secondary hypertension;
2. Patients living solely;
3. Refuse to participate;
4. With advanced complications.

研究实施时间:

Study execute time:

From 2012-02-01 00:00:00 To 2012-10-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2012-02-15 00:00:00 To 2012-03-15 00:00:00

干预措施:

Interventions:

组别:

样本量:

150

Group:

1

Sample size:

干预措施:

干预措施代码:

Intervention:

family member-based education program

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):

扬中 

单位级别:

县 

Institution
hospital:

Yangzhong

Level of the institution:

Secondary A hospital

测量指标:

Outcomes:

指标中文名:

治疗依从性

指标类型:

主要指标

Outcome:

Treatment adherence

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压值改变情况

指标类型:

主要指标

Outcome:

Blood pressure

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

可接受性

指标类型:

次要指标

Outcome:

Acceptability

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

可行性

指标类型:

次要指标

Outcome:

Feasibility

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 30 years
最大 Max age 80 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:

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):

南京医科大学

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

Nanjing Medical 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:

南京医科大学

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

Nanjing Medical University

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2012-02-17 00:00:00