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Effectiveness of a pathway-driven eHealth-based integrated care model for hypertension management in China
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注册号:

Registration number:

ChiCTR1900027645 

最近更新日期:

Date of Last Refreshed on:

2019-11-23 

注册时间:

Date of Registration:

2019-11-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

探究路径驱动的电子化慢病协同管理服务模式对高血压患者的干预效果研究 

Public title:

Effectiveness of a pathway-driven eHealth-based integrated care model for hypertension management in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

探究路径驱动的电子化慢病协同管理服务模式对高血压患者的干预效果研究 

Scientific title:

Effectiveness of a pathway-driven eHealth-based integrated care model for hypertension management in China 

研究课题代号(代码):

Study subject ID:

2018YFC0910503; 2017YFC0114105; 2017YFB1002301; 2018BFG02009 

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:

段会龙 

研究负责人:

段会龙 

Applicant:

Huilong Duan 

Study leader:

Huilong Duan 

申请注册联系人电话:

Applicant telephone:

+86 13515816864 

研究负责人电话:

Study leader's telephone:

+86 13515816864 

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:

dengn@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

dengn@zju.edu.cn 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cbeis.zju.edu.cn/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://person.zju.edu.cn/0091070 

申请注册联系人通讯地址:

浙江省杭州市西湖区浙大路38号 

研究负责人通讯地址:

浙江省杭州市西湖区浙大路38号 

Applicant address:

38 Zheda Road, Xihu District, Hangzhou, Zhejiang, China 

Study leader's address:

38 Zheda Road, Xihu District, Hangzhou, Zhejiang, China  

申请注册联系人邮政编码:

Applicant postcode:

310027 

研究负责人邮政编码:

Study leader's postcode:

310027 

申请人所在单位:

浙江大学 

Applicant's institution:

Zhejiang 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:

2019-005 

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:

宜宾市第一人民医院医学伦理委员会 

Name of the ethic committee:

The Medical Ethics Committee of the First People’s Hospital of Yibin 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-06 

伦理委员会联系人:

谢均明 

Contact Name of the ethic committee:

Junming Xie 

伦理委员会联系地址:

四川省宜宾市文星街65号 

Contact Address of the ethic committee:

65 Wenxin Street, Yibin, Sichuan, China  

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:

浙江大学 

Primary sponsor:

Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市西湖区浙大路38号 

Primary sponsor's address:

38 Zheda Road, Xihu District, Hangzhou, Zhejiang, 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):

四川

市(区县):

宜宾

Country:

China

Province:

Sichuan

City:

Yibin

单位(医院):

宜宾市第一人民医院

具体地址:

宜宾市南岸商贸路108号

Institution
hospital:

108 Nan'an Shangmao Road, Yibin, Sichuan

Address:

108 Nan'an Shangmao Road, Yibin, Sichuan

经费或物资来源:

本研究由国家重点研发计划课题(编号No. 2018YFC0910503, No. 2017YFC0114105, No. 2017YFB1002301),宁夏回族自治区重点研发计划课题(编号No. 2018BFG02009)资助 

Source(s) of funding:

This study was supported by the National Key Research and Development Program of China and the Key Research and Development Program of Ningxia 

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:

探索性研究/预试验 

Study phase:

研究目的:

探究路径驱动的电子化慢病协同管理模型在中国的高血压院外管理中的可行性及有效性。 

Objectives of Study:

To investigate the feasibility and effectiveness of a pathway-driven eHealth-based integrated care model for hypertension management in China. 

药物成份或治疗方案详述:

对照组:基于指南中规定的流程对院外患者进行管理,患者可使用智能监测终端进行血压的测量; 试验组:基于提出的路径驱动的协同管理模型对患者进行管理,患者可使用智能监测终端执行定制化的自我管理,并接受医生的监督与干预。 

Description for medicine or protocol of treatment in detail:

Control group: perform management regimes according to the guidelines combined with a partial-accessed smart self-monitoring terminal; Intervention Group: perform management regimes according a pathway-driven integrated care model combined with a full-accessed smart self-monitoring terminal. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 18至80周岁 2. 已确诊高血压至少一年且血压未达标 3. 能够流利地听、说普通话或四川方言 4. 能够流畅地操作智能手机 5. 大部分的就诊在试验医院进行 6. 没有行动障碍 

Inclusion criteria

1. aged 18-80 years; 2. hypertension diagnosis with uncontrolled BP for at least one year; 3. fluent in Mandarin or Sichuan dialect; 4. being able to use the system fluently after instruction; 5. mainly visiting the hospital where the trial is hold; 6. having no walking disability. 

排除标准:

1. 本研究开始前4周曾参加过其他临床试验 2. 有精神异常的患者 3. 同时患有肿瘤,且近半年接受过化疗者 4. 患有心梗的患者 5. 合并其他重疾且自然病程小于一年的患者 6. 无法访问网络的患者 7. 怀孕或准备怀孕的病人 

Exclusion criteria:

1. participating in another trial four weeks before this study; 2. suffering from mental health problem; 3. suffering from cancer and receiving chemotherapy within half a year; 4. suffering from myocardial infarction; 5. suffering from other serious diseases with natural course shorter than 1 year; 6. having no access to the Internet; 7. pregnant or trying to get pregnant. 

研究实施时间:

Study execute time:

From2020-07-30To 2021-07-30 

干预措施:

Interventions:

组别:

对照组

样本量:

201

Group:

Control Group

Sample size:

干预措施:

指南结合自我监测

干预措施代码:

Intervention:

Usual care

Intervention code:

组别:

试验组

样本量:

201

Group:

Intervention Group

Sample size:

干预措施:

路径驱动的管理模型结合自我监测

干预措施代码:

Intervention:

Management based on the pathway

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

宜宾 

Country:

China 

Province:

Sichuan 

City:

Yibin 

单位(医院):

宜宾市第一人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First People's Hospital of Yibin  

Level of the institution:

Tertiary Hospital 

测量指标:

Outcomes:

指标中文名:

收缩压

指标类型:

主要指标 

Outcome:

Systolic 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:

舒张压

指标类型:

次要指标 

Outcome:

Diastolic pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

舒张压

指标类型:

次要指标 

Outcome:

Diastolic pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿素氮

指标类型:

次要指标 

Outcome:

Urea nitrogen

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

次要指标 

Outcome:

Creatinine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷丙转氨酶

指标类型:

次要指标 

Outcome:

Alanine transaminase

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷草转氨酶

指标类型:

次要指标 

Outcome:

Aspartate transaminase

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿酸

指标类型:

次要指标 

Outcome:

Blood uric acid

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

次要指标 

Outcome:

Total cholesterol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

次要指标 

Outcome:

Triglyceride

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白

指标类型:

次要指标 

Outcome:

High-density lipoprotein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白

指标类型:

次要指标 

Outcome:

Low-density lipoprotein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

24小时尿钠

指标类型:

次要指标 

Outcome:

24-hour urinary sodium

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

24小时尿钾

指标类型:

次要指标 

Outcome:

24-hour urinary potassium

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

Questionnaires

指标中文名:

依从度

指标类型:

次要指标 

Outcome:

Compliance

Type:

Secondary indicator 

测量时间点:

测量方法:

问卷及系统日志

Measure time point of outcome:

Measure method:

Questionnaires and system logs

指标中文名:

知识知晓率

指标类型:

次要指标 

Outcome:

knowledge awareness

Type:

Secondary indicator 

测量时间点:

测量方法:

问卷

Measure time point of outcome:

Measure method:

Questionnaires

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 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):

随机序列将由一名研究人员通过 SPSS 23.0 软件生成。

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

One researcher will generate the randomized allocation sequence using SPSS version 23.0 which allocates 50% of the participants to either group.

盲法:

不设盲法。

Blinding:

None.

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

在2022年1月前以发表文章的形式公布数据

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

Publish original data by January 2022 in the form of articles

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:

数据采集和管理由病例记录表(Case Record Form, CRF) 和电子采集和管理系统( Electronic Data Capture system (EDC)) 共同完成

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

Data collection and management are completed by Case Record Form (CRF) and Electronic Data Capture system (EDC)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-11-22
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