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基于移动互联网的CABG术后管理对药物依从性影响:随机对照试验
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注册号:

Registration number:

ChiCTR1800018809 

最近更新日期:

Date of Last Refreshed on:

2018-10-10 

注册时间:

Date of Registration:

2018-10-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于移动互联网的CABG术后管理对药物依从性影响:随机对照试验 

Public title:

Mhealth based intervention to improve the medication adherence for patients undergoing CABG: a randomised controlled trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于移动互联网的CABG术后管理对药物依从性影响:随机对照试验 

Scientific title:

Mhealth based intervention to improve the medication adherence for patients undergoing CABG: a randomised controlled trial  

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:

王锦纹 

研究负责人:

王锦纹 

Applicant:

Wang Jinwen 

Study leader:

Wang Jinwen 

申请注册联系人电话:

Applicant telephone:

+86 13366240290 

研究负责人电话:

Study leader's telephone:

+86 13366240290 

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:

wang-jin-wen@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wang-jin-wen@163.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:

北京市朝阳区安贞路2号 北京安贞医院 北京市心肺血管疾病研究所  

研究负责人通讯地址:

北京市朝阳区安贞路2号 北京安贞医院 北京市心肺血管疾病研究所  

Applicant address:

2 Anzhen Road, Chaoyang District, Beijing, China  

Study leader's address:

2 Anzhen Road, Chaoyang District, Beijing, China  

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:

北京安贞医院 北京市心肺血管疾病研究所 

Applicant's institution:

Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Disease  

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:

2017010 

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:

北京安贞医院临床研究伦理委员会 

Name of the ethic committee:

Drug Clinical Research Ethics Committee of Beijing Anzhen Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

吴朝阳 

Contact Name of the ethic committee:

Wu Chaoyang 

伦理委员会联系地址:

北京市朝阳区安贞路2号 北京安贞医院 

Contact Address of the ethic committee:

2 Anzhen Road, Chaoyang District, Beijing, 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:

北京安贞医院 北京市心肺血管疾病研究所 

Primary sponsor:

Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Disease  

研究实施负责(组长)单位地址:

北京市朝阳区安贞路2号 北京安贞医院 北京市心肺血管疾病研究所  

Primary sponsor's address:

2 Anzhen Road, Chaoyang District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京安贞医院 北京市心肺血管疾病研究所

具体地址:

北京市朝阳区安贞路2号 北京安贞医院 北京市心肺血管疾病研究所

Institution
hospital:

Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart Lung and Blood Vessel Disease

Address:

2 Anzhen Road, Chaoyang District, Beijing, China

经费或物资来源:

北京市卫生和计划生育委员会 

Source(s) of funding:

Beijing municipal Commission of Health and Family Planning 

研究疾病:

冠心病 

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:

评价互联网为基础的冠心病患者术后康复管理模式与传统冠心病术后管理模式相比的干预效果如何 

Objectives of Study:

The objective of this study is to investigate whether a mhealth-based (WeChat) rehabilitation/secondary prevention programme can improve disease self-management and health outcomes in patients with coronary heart disease (CHD), after coronary artery bypass grafting (CABG) therapy. 

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:

1. CABG术后; 2. 35-75岁; 3. 熟练使用手机并可以访问互联网。拥有3G/4G功能的智能移动设备。 

Inclusion criteria

(1) patients undergoing CABG; (2) aged 35-75 years; (3) smartphone owners and ability to use mobile application.  

排除标准:

1. 合并以下疾病之一:主动脉瘤、主动脉夹层、瓣膜病、心肌病、房颤、慢性肾病、肿瘤、遗传性疾病、慢性肾衰透析; 2. 合并以下手术:瓣膜置换术、先心病手术、房颤治疗手术、心脏损伤修复手术; 3. 患者不能遵守研究方案,如不能随访以及不可能完成本研究 4. 生活不能自理(如残疾、痴呆、精神心理疾患等); 

Exclusion criteria:

(1) Had one of the following diseases: aortic aneurysm, aortic dissection, valvular disease, cardiomyopathy, atrial fibrillation, chronic kidney disease, tumor, genetic disease, chronic renal failure dialysis; (2) Combined with the following surgery: valve replacement, congenital heart disease surgery, atrial fibrillation surgery, repair of heart injury surgery; (3) Unwillingness to be followed for a period of 12 months; (4) Dementia, mental illness or any condition that would limit ability to read, write, or communicate, or were considered to be inappropriate for the study by the physician. 

研究实施时间:

Study execute time:

From2018-10-15To  

征募观察对象时间:

Recruiting time:

From2018-10-15To 2018-12-15 

干预措施:

Interventions:

组别:

干预组

样本量:

70

Group:

Intervention group

Sample size:

干预措施:

基于微信公众号的术后康复指导

干预措施代码:

Intervention:

mhealth-based (WeChat) rehabilitation/secondary prevention programme

Intervention code:

组别:

对照组

样本量:

70

Group:

Control group

Sample size:

干预措施:

常规管理

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):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京安贞医院 

单位级别:

三级医院 

Institution
hospital:

Beijing Anzhen Hospital  

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

药物依从性

指标类型:

主要指标 

Outcome:

medication 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:

心血管危险因素

指标类型:

次要指标 

Outcome:

change in cardiovascular disease risk factors

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:

标本中文名:

组织:

Sample Name:

None

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 35 years
最大 Max age 75 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):

拟采用安贞医院临床试验数据管理平台创建SAS 9.4软件产生随机隐匿表,采用随机隐匿方法按1:1随机原则入组。经入选及排除标准筛选患者后,研究者按患者入组时间顺序随机入组微信管理组或常规管理组组,每位受试者的患者编号在研究过程中保持不变。

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

The clinical data management platform of Beijing Anzhen Hospital is commissioned to create SAS 9.4 software to generate random concealment table tables. Masked envelopes will be produced by random concealment and participants are admitted by 1:1 random principle. After screening for inclusion and exclusion criteria

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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2021年6月前以参加会议发言或发表文章的方式公布原始数据

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

Publish original data by June 2021 in the form of meetings, speeches or articles; via ResMan

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)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 is completed by Case Record Form (CRF)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-10
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