ChiCTR2100049535 版本V1.1 版本创建时间2021/08/02 14:45:00 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100049535 

最近更新日期：

Date of Last Refreshed on：

2021-08-02 14:42:21 

注册时间：

Date of Registration：

2021-08-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Tashi Dorje: please submit the approval letter of IRB or ethics committee 请提交伦理批准件 Socia

Public title：

Social media and smartphone-based high blood pressure management

注册题目简写：

English Acronym：

WECARE hypertension

研究课题的正式科学名称：

Social media-delivered care for improving hypertension management in the Tibetan plateau: the WECARE randomised controlled trial protocol

Scientific title：

Social media-delivered care for improving hypertension management in the Tibetan plateau: the WECARE randomised controlled trial protocol

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：

Tashi Dorje 

研究负责人：

Tashi Dorje 

Applicant：

Tashi Dorje 

Study leader：

Tashi Dorje 

申请注册联系人电话：

Applicant telephone：

+61 8 6152 0872

研究负责人电话：

Study leader's telephone：

+61 8 6152 0872

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：

woshiyak@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

woshiyak@gmail.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：

11 Robin Warren Dr, Murdoch WA 6150, Australia

研究负责人通讯地址：

11 Robin Warren Dr, Murdoch WA 6150, Australia

Applicant address：

11 Robin Warren Dr, Murdoch WA 6150, Australia

Study leader's address：

11 Robin Warren Dr, Murdoch WA 6150, Australia

申请注册联系人邮政编码：

Applicant postcode：

6149

研究负责人邮政编码：

Study leader's postcode：

6150

申请人所在单位：

澳大利亚Curtin University

Applicant's institution：

Curtin University

研究负责人所在单位：

澳大利亚Curtin University

Affiliation of the Leader：

Curtin University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

P-SL-2019069

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：

Human Research Ethics Committee of Qinghai University Affiliated Hospital

Name of the ethic committee：

Human Research Ethics Committee of Qinghai University Affiliated Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2019-08-01 00:00:00

伦理委员会联系人：

Ma LiLI

Contact Name of the ethic committee：

Ma LiLI

伦理委员会联系地址：

青海省西宁市同仁路29号

Contact Address of the ethic committee：

29 Tongren Road, Xi'ning, Qinghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 971-6162000

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：

China Medical Board

Primary sponsor：

China Medical Board

研究实施负责（组长）单位地址：

1st Floor, Old Building 12 Peking Union Medical College Hospital No. 1 Shuaifuyuan, Dongcheng District Beijing 100730

Primary sponsor's address：

1st Floor, Old Building 12 Peking Union Medical College Hospital No. 1 Shuaifuyuan, Dongcheng District Beijing 100730

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

澳大利亚

省(直辖市)：

WA

市(区县)：

Bentley

Country：

Australia

Province：

WA

City：

Bentley

单位(医院)：

Curtin University

具体地址：

Kent St

Institution
hospital：

Curtin University

Address：

Kent St

国家：

中国

省(直辖市)：

青海

市(区县)：

西宁

Country：

China

Province：

Qinghai

City：

Xining

单位(医院)：

Qinghai University Affiliated Hospital

具体地址：

29 Tongren Road, Xi'ning, Qinghai, China

Institution
hospital：

Qinghai University Affiliated Hospital

Address：

29 Tongren Road, Xi'ning, Qinghai, China

经费或物资来源：

China Medical Board

Source(s) of funding：

China Medical Board

Target disease：

Hypertension

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The aim of this study is to evaluate the effectiveness of a social media-delivered comprehensive hypertension management programme in patients with uncontrolled hypertension.  

Objectives of Study：

The aim of this study is to evaluate the effectiveness of a social media-delivered comprehensive hypertension management programme in patients with uncontrolled hypertension.

药物成份或治疗方案详述：

Participants will be randomised (1:1 ratio) to receive either usual care, or WECARE (WEChat-based healthCARE). The WECARE programme provides comprehensive hypertension management consisting of online health education, remote monitoring and management of blood pressure (BP), individualised support for cardiovascular disease (CVD) risk assessment and modification, and maintenance of antihypertensive medication adherence and hypertension management self-efficacy. This will be delivered exclusively via WeChat, a popular social media platform in China.  

Description for medicine or protocol of treatment in detail：

Participants will be randomised (1:1 ratio) to receive either usual care, or WECARE (WEChat-based healthCARE). The WECARE programme provides comprehensive hypertension management consisting of online health education, remote monitoring and management of blood pressure (BP), individualised support for cardiovascular disease (CVD) risk assessment and modification, and maintenance of antihypertensive medication adherence and hypertension management self-efficacy. This will be delivered exclusively via WeChat, a popular social media platform in China.  

纳入标准：

Individuals will be eligible if they are WeChat users, have an operating smartphone, and are aged between 18 or over. Have had a medical history of hypertension documented for six or more months and have at least two measures in the last three months indicating poor control. Participants will be also required to have sufficient Chinese or Tibetan language proficiency, as well as digital literacy in using WeChat and the internet, to enable WeChat-based health education and communication with the WECARE team.

Inclusion criteria

Individuals will be eligible if they are WeChat users, have an operating smartphone, and are aged between 18 or over. Have had a medical history of hypertension documented for six or more months and have at least two measures in the last three months indicating poor control. Participants will be also required to have sufficient Chinese or Tibetan language proficiency, as well as digital literacy in using WeChat and the internet, to enable WeChat-based health education and communication with the WECARE team.

排除标准：

Individuals will be excluded if they are currently receiving any mHealth-based hypertension management programme, have no internet access at their place of residence, or are unable to operate a smartphone, or Bluetooth-enabled BP monitor for the purpose of the trial (e.g., vision, hearing, cognitive or dexterity impairment). Other exclusion criteria include the following: a known cause of secondary hypertension; acute coronary syndrome, coronary revascularisation or stroke, within the past three months; heart failure; or receiving haemodialysis or chemotherapy.

Exclusion criteria：

Individuals will be excluded if they are currently receiving any mHealth-based hypertension management programme, have no internet access at their place of residence, or are unable to operate a smartphone, or Bluetooth-enabled BP monitor for the purpose of the trial (e.g., vision, hearing, cognitive or dexterity impairment). Other exclusion criteria include the following: a known cause of secondary hypertension; acute coronary syndrome, coronary revascularisation or stroke, within the past three months; heart failure; or receiving haemodialysis or chemotherapy.

研究实施时间：

Study execute time：

从 From 2021-06-01 00:00:00至 To 2024-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-08-03 00:00:00 至 To 2023-01-01 00:00:00  

干预措施：

Interventions：

组别：

1

样本量：

230

Group：

1

Sample size：

干预措施：

WECARE hypertension mangement program

干预措施代码：

Intervention：

WECARE hypertension mangement program

Intervention code：

组别：

2

样本量：

230

Group：

2

Sample size：

干预措施：

Usual care

干预措施代码：

Intervention：

Usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 青海 

市(区县)：

 西宁 

Country：

China 

Province：

Qinghai 

City：

Xining 

单位(医院)：

Qinghai University Affiliated Hospital 

单位级别：

三级医院 

Institution
hospital：

Qinghai University Affiliated Hospital

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 青海 

市(区县)：

 玉树 

Country：

China 

Province：

Qinghai 

City：

Yushu 

单位(医院)：

Yushu People's Hospital 

单位级别：

三级医院 

Institution
hospital：

Yushu People's Hospital

Level of the institution：

Tetiary

国家：

 中国

省(直辖市)：

 青海 

市(区县)：

  

Country：

China 

Province：

Qinghai 

City：

Qilian 

单位(医院)：

Qilian County People's Hospital 

单位级别：

 

Institution
hospital：

Qilian County People's Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

The difference in change in mean systolic BP between the two follow-up points

指标类型：

主要指标

Outcome：

The difference in change in mean systolic BP between the two follow-up points

Type：

Primary indicator

测量时间点：

Baseline and six month

测量方法：

Measured using a standard protocol via a Bluetooth-enabled automated monitor identical to the home monitor used during the study

Measure time point of outcome：

Baseline and six month

Measure method：

Measured using a standard protocol via a Bluetooth-enabled automated monitor identical to the home monitor used during the study

指标中文名：

Change in mean Diastolic BP

指标类型：

次要指标

Outcome：

Change in mean Diastolic BP

Type：

Secondary indicator

测量时间点：

Baseline and six month

测量方法：

Measured using a standard protocol via a Bluetooth-enabled automated monitor identical to the home monitor used during the study

Measure time point of outcome：

Baseline and six month

Measure method：

Measured using a standard protocol via a Bluetooth-enabled automated monitor identical to the home monitor used during the study

指标中文名：

Change in cardiovascular health literacy,

指标类型：

次要指标

Outcome：

Change in cardiovascular health literacy,

Type：

Secondary indicator

测量时间点：

Baseline and six month

测量方法：

Health literacy will be assessed using a questionnaire developed by the research team based on contemporary clinical guidelines.

Measure time point of outcome：

Baseline and six month

Measure method：

Health literacy will be assessed using a questionnaire developed by the research team based on contemporary clinical guidelines.

指标中文名：

Adherence to antihypertensive medications

指标类型：

次要指标

Outcome：

Adherence to antihypertensive medications

Type：

Secondary indicator

测量时间点：

Baseline and six month

测量方法：

Self-reported adherence to antihypertensive medications will be recorded using the Morisky’s 8-item scale (modified for BP medications)

Measure time point of outcome：

Baseline and six month

Measure method：

Self-reported adherence to antihypertensive medications will be recorded using the Morisky’s 8-item scale (modified for BP medications)

指标中文名：

CVD risk factors including both behavioural and psychosocial factors

指标类型：

次要指标

Outcome：

CVD risk factors including both behavioural and psychosocial factors

Type：

Secondary indicator

测量时间点：

Baseline and six month

测量方法：

Using pre-defined protocol

Measure time point of outcome：

Baseline and six month

Measure method：

Using pre-defined protocol

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

组织：

No

Sample Name：

Blood

Tissue：

None

人体标本去向

 使用后销毁  

说明

NA

Fate of sample：

Destruction after use  

Note：

None

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 岁 years
最大 Max age 100 岁 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）：

Following the provision of written informed consent, participants will be randomised in a 1:1 fashion to the WECARE group, or a usual care group, using central randomisation, with variable block size and stratification by gender, age and baseline treatment status (no medication/medical therapy).

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

Following the provision of written informed consent, participants will be randomised in a 1:1 fashion to the WECARE group, or a usual care group, using central randomisation, with variable block size and stratification by gender, age and baseline treatment status (no medication/medical therapy).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

To maintain blinding of study personnel involved in follow-up assessments to group allocation, participants will be informed of their allocation via a WeChat message sent after leaving the trial sites.

Blinding：

To maintain blinding of study personnel involved in follow-up assessments to group allocation, participants will be informed of their allocation via a WeChat message sent after leaving the trial sites.

是否共享原始数据：

IPD sharing

Yes

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）：

Metadata and protocol

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

Metadata and protocol

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：

Study data will be collected and managed using REDCap electronic data capture tools hosted by Curtin University. A study Steering Committee consisting of the authors and the principal investigators of all participating hospitals will be established to guide the project and quality control. Data will be de-identified and accessible only by researchers required to enter or analyse data.

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

Study data will be collected and managed using REDCap electronic data capture tools hosted by Curtin University. A study Steering Committee consisting of the authors and the principal investigators of all participating hospitals will be established to guide the project and quality control. Data will be de-identified and accessible only by researchers required to enter or analyse data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-02 14:40:20