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The effectiveness of eHealth cardiac rehabilitation on health outcomes of Chinese patients with coronary artery disease
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注册号:

Registration number:

ChiCTR1800020411 

最近更新日期:

Date of Last Refreshed on:

2018-12-28 

注册时间:

Date of Registration:

2018-12-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

The effectiveness of eHealth cardiac rehabilitation on health outcomes of Chinese patients with coronary artery disease 

Public title:

The effectiveness of eHealth cardiac rehabilitation on health outcomes of Chinese patients with coronary artery disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

The effectiveness of eHealth cardiac rehabilitation on health outcomes of Chinese patients with coronary artery disease 

Scientific title:

The effectiveness of eHealth cardiac rehabilitation on health outcomes of Chinese patients with coronary artery disease 

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:

苏晶晶 

研究负责人:

苏晶晶 

Applicant:

Jing Jing Su 

Study leader:

Jing Jing Su 

申请注册联系人电话:

Applicant telephone:

+852 52676410 

研究负责人电话:

Study leader's telephone:

+852 52676410 

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:

sujj@link.cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

sujj@link.cuhk.edu.hk 

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:

601 Esther Lee building, The Chinese University of Hong Kong, Shatin, Hong Kong 

研究负责人通讯地址:

601 Esther Lee building, The Chinese University of Hong Kong, Shatin, Hong Kong 

Applicant address:

601 Esther Lee building, The Chinese University of Hong Kong, Shatin, Hong Kong 

Study leader's address:

601 Esther Lee building, The Chinese University of Hong Kong, Shatin, Hong Kong 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

香港中文大學 

Applicant's institution:

The Chinese University of Hong Kong 

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:

2018469 

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:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-12 

伦理委员会联系人:

Envy Lee 

Contact Name of the ethic committee:

Envy Lee 

伦理委员会联系地址:

中國香港特別行政區沙田威爾斯親王醫院呂志和臨床科學大樓 

Contact Address of the ethic committee:

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong 

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:

香港中文大學 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

中國香港特別行政區沙田威爾斯親王醫院 

Primary sponsor's address:

Shatin, The Chinese University of Hong Kong, Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

Individual funded 

Source(s) of funding:

Individual funded 

研究疾病:

冠狀動脈疾病 

Target disease:

Coronary artery disease 

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:

1. To determine the effect of NeCR on lifestyle behavior including physical activity level, dietary habit, and smoking habit among Chinese patients who discharged from an exacerbation of CAD. 2. To determine the effect of a NeCR on self-efficacy in CAD management among Chinese patients who discharged from an exacerbation of CAD. 3. To determine the effect of a NeCR on psychological well-being including stress, anxiety, and depression Chinese patients who just discharged from an exacerbation of CAD. 4. To determine the effect of a NeCR on disease-specific health-related quality of life among Chinese patients who just discharged from an exacerbation of CAD. 5. To determine the effect of a NeCR on cardiovascular risk parameters including blood pressure, body mass index, and waist circumference of Chinese patients who just discharged from an exacerbation of CAD. 6. To determine the effect of the NeCR on unplanned health services utilization including cardiac-related hospital readmission or emergency department visits in of Chinese patients who discharged from an exacerbation of CAD. 7. To explore the acceptability of NeCR among Chinese patients who discharged from an exacerbation of CAD in terms of their engagement level and experience of using this innovative service.  

Objectives of Study:

1. To determine the effect of NeCR on lifestyle behavior including physical activity level, dietary habit, and smoking habit among Chinese patients who discharged from an exacerbation of CAD. 2. To determine the effect of a NeCR on self-efficacy in CAD management among Chinese patients who discharged from an exacerbation of CAD. 3. To determine the effect of a NeCR on psychological well-being including stress, anxiety, and depression Chinese patients who just discharged from an exacerbation of CAD. 4. To determine the effect of a NeCR on disease-specific health-related quality of life among Chinese patients who just discharged from an exacerbation of CAD. 5. To determine the effect of a NeCR on cardiovascular risk parameters including blood pressure, body mass index, and waist circumference of Chinese patients who just discharged from an exacerbation of CAD. 6. To determine the effect of the NeCR on unplanned health services utilization including cardiac-related hospital readmission or emergency department visits in of Chinese patients who discharged from an exacerbation of CAD. 7. To explore the acceptability of NeCR among Chinese patients who discharged from an exacerbation of CAD in terms of their engagement level and experience of using this innovative service.  

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:

Patients eligible for the study if they (1) are 18 years or above; (2) admitted for an index diagnosis of CHD as documented in the medical record; (3) access to the Internet at home via computer or smart phone (use internet search such as Baidu or software such as WeChat); (4) understand and speak Chinese; and (5) no exercise restriction according to the doctors prescription for post-discharge care in the medial record and doctors confirmation.  

Inclusion criteria

Patients eligible for the study if they (1) are 18 years or above; (2) admitted for an index diagnosis of CHD as documented in the medical record; (3) access to the Internet at home via computer or smart phone (use internet search such as Baidu or software such as WeChat); (4) understand and speak Chinese; and (5) no exercise restriction according to the doctors prescription for post-discharge care in the medial record and doctors confirmation.  

排除标准:

Patients with a diagnosis of acute psychotic disease/ life-limiting condition, absolute and relative contradictions to exercise testing and training and high risk for exercise prescription according to American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guideline (AACVPR, 2013; Diniz et al., 2017; OGara et al., 2013), and not discharge to home will be excluded.  

Exclusion criteria:

Patients with a diagnosis of acute psychotic disease/ life-limiting condition, absolute and relative contradictions to exercise testing and training and high risk for exercise prescription according to American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guideline (AACVPR, 2013; Diniz et al., 2017; OGara et al., 2013), and not discharge to home will be excluded.  

研究实施时间:

Study execute time:

From2019-02-20To 2019-10-01 

征募观察对象时间:

Recruiting time:

From2019-02-25To 2019-06-30 

干预措施:

Interventions:

组别:

usual care

样本量:

73

Group:

usual care

Sample size:

干预措施:

health education

干预措施代码:

Intervention:

health education

Intervention code:

组别:

Intervention

样本量:

73

Group:

Intervention

Sample size:

干预措施:

eHealth cardiac rehabilitation

干预措施代码:

Intervention:

eHealth cardiac rehabilitation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

同济医院 

单位级别:

三甲医院 

Institution
hospital:

Tongji  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

Health behavior

指标类型:

主要指标 

Outcome:

Health behavior

Type:

Primary indicator 

测量时间点:

测量方法:

Questionnaire

Measure time point of outcome:

Measure method:

Questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

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 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):

分段随机;计算机软件

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

Three different block sizes including size of 4, 6 and 8 will be used. The random number for group assignment will be generated by random allocation software used by the researcher. The group assignment will be written and placed in an opaque and sealed envelope.

盲法:

未说明

Blinding:

Not stated

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):

The raw data will be submitted to the journal during submission.

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

The raw data will be submitted to the journal during submission.

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:

The data retrieved from the medical record, from the website counter, and from the questionnaire by interview will be saved in an excel file.

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

The data retrieved from the medical record, from the website counter, and from the questionnaire by interview will be saved in an excel file.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-12-28
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