今天是:2019-06-25 星期二

Self-Monitoring of Blood Pressure (SMBP) with Nurses support amongst hypertensive patients in Vietnam
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注册号:

Registration number:

ChiCTR1800015794 

最近更新日期:

Date of Last Refreshed on:

2018-04-20 

注册时间:

Date of Registration:

2018-04-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Self-Monitoring of Blood Pressure (SMBP) with Nurses support amongst hypertensive patients in Vietnam 

Public title:

Self-Monitoring of Blood Pressure (SMBP) with Nurses support amongst hypertensive patients in Vietnam 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Self-Monitoring of Blood Pressure (SMBP) with Nurses support amongst hypertensive patients in Vietnam 

Scientific title:

Self-Monitoring of Blood Pressure (SMBP) with Nurses support amongst hypertensive patients in Vietnam 

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:

Dung Thi Nguyen 

研究负责人:

Yan Cui 

Applicant:

Dung Thi Nguyen 

Study leader:

Yan Cui 

申请注册联系人电话:

Applicant telephone:

+86 13770983113 

研究负责人电话:

Study leader's telephone:

+86 25 86869551 

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:

nguyenthidung006@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

cyan@njmu.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:

中国江苏南京江宁区龙眠大道101大道 

研究负责人通讯地址:

中国江苏南京江宁区龙眠大道101大道 

Applicant address:

101 Longmian Avenue, Jiangning District, Nanjing, China. 

Study leader's address:

101 Longmian Avenue, Jiangning District, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

211166 

研究负责人邮政编码:

Study leader's postcode:

211166 

申请人所在单位:

南京医科大学 

Applicant's institution:

Nanjing Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

NJMUIRB2018001 

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:

南京医科大学伦理委员会 

Name of the ethic committee:

Ethics Committee Nanjing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-04-09 

伦理委员会联系人:

南京医科大学伦理委员会 

Contact Name of the ethic committee:

Ethics Committee Nanjing Medical University 

伦理委员会联系地址:

中国江苏南京汉中路140号 

Contact Address of the ethic committee:

140 Hanzhong Road, Nanjing, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 25 86862684 

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 

Primary sponsor:

Nanjing Medical University 

研究实施负责(组长)单位地址:

中国江苏南京江宁区龙眠大道101大道 

Primary sponsor's address:

101 Longmian Avenue, Jiangning District, 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):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京医科大学

具体地址:

中国江苏南京江宁区龙眠大道101大道

Institution
hospital:

Nanjing Medical University

Address:

140 Hanzhong Road, Nanjing Medical University, Nanjing city, China.

经费或物资来源:

self-financing 

Source(s) of funding:

self-financing 

研究疾病:

高血压 

Target disease:

hypertension 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

This study determines the effect of Self-monitoring of Blood Pressure on Blood Pressure reduction and lifestyle modifications with the nurse support hypertensive patients in Vietnam. 

Objectives of Study:

This study determines the effect of Self-monitoring of Blood Pressure on Blood Pressure reduction and lifestyle modifications with the nurse support hypertensive patients in Vietnam. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

Eligible participants included patients will be defined as hypertension according to the clinical record (defined as a systolic Blood pressure≥ 140 mm Hg and/or average Diastolic Blood pressure ≥ 90 mm Hg) or treatment with anti-hypertensive medications; aged 18 years or older; living in Lam Dong province; Vietnamese speaking.  

Inclusion criteria

Eligible participants included patients will be defined as hypertension according to the clinical record (defined as a systolic Blood pressure≥ 140 mm Hg and/or average Diastolic Blood pressure ≥ 90 mm Hg) or treatment with anti-hypertensive medications; aged 18 years or older; living in Lam Dong province; Vietnamese speaking.  

排除标准:

Exclusion criteria included the following: Participants who cannot communicate effectively with the study personnel; already using a home blood pressure monitor; severe cognitive impairment defined as Abbreviated Mental Test Score <7; known secondary hypertension. 

Exclusion criteria:

Exclusion criteria included the following: Participants who cannot communicate effectively with the study personnel; already using a home blood pressure monitor; severe cognitive impairment defined as Abbreviated Mental Test Score <7; known secondary hypertension. 

研究实施时间:

Study execute time:

From2018-08-01To 2019-02-01 

干预措施:

Interventions:

组别:

Group 1

样本量:

30

Group:

Group 1

Sample size:

干预措施:

Measuring the blood pressure

干预措施代码:

Intervention:

Measuring the blood pressure

Intervention code:

组别:

Group 2

样本量:

30

Group:

Group 2

Sample size:

干预措施:

Lifestyle counseling, Medical education

干预措施代码:

Intervention:

Lifestyle counseling, Medical education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

越南 

省(直辖市):

林同 

市(区县):

大叻 

Country:

Vietnam 

Province:

Lam Dong 

City:

Da Lat 

单位(医院):

Lam Dong Province Hospital 

单位级别:

三甲医院 

Institution
hospital:

Lam Dong Province Hospital  

Level of the institution:

Tertiary A Hospital