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评估华法林居家管理(SMART模式)的有效性、安全性和成本效益:一项多中心随机对照研究
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注册号:

Registration number:

ChiCTR2000038984 

最近更新日期:

Date of Last Refreshed on:

2021-01-10 

注册时间:

Date of Registration:

2020-10-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评估华法林居家管理(SMART模式)的有效性、安全性和成本效益:一项多中心随机对照研究 

Public title:

Assessing the effectiveness, safety and cost-effectiveness of the “Safe Multidisciplinary App-Assisted Remote Patient-Self-Testing (SMART) Model” for warfarin home management: a multi-center randomized controlled trial 

注册题目简写:

华法林居家管理 

English Acronym:

warfarin home management 

研究课题的正式科学名称:

评估华法林居家管理(SMART模式)的有效性、安全性和成本效益:一项多中心随机对照研究 

Scientific title:

Assessing the effectiveness, safety and cost-effectiveness of the “Safe Multidisciplinary App-Assisted Remote Patient-Self-Testing (SMART) Model” for warfarin home management: a multi-center randomized 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:

谭胜蓝 

研究负责人:

谭胜蓝 

Applicant:

Shenglan Tan 

Study leader:

Shenglan Tan 

申请注册联系人电话:

Applicant telephone:

+86 13467589877 

研究负责人电话:

Study leader's telephone:

+86 13467589877 

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:

94794635@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

94794635@qq.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:

中国湖南省长沙市人民中路139号 

研究负责人通讯地址:

湖南省长沙市人民中路139号 

Applicant address:

139 Renmin Road Middle, Changsha, Hu'nan, China 

Study leader's address:

139 Renmin Road Middle, Changsha, Hu'nan, 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:

中南大学湘雅二医院 

Applicant's institution:

The Second Xiangya Hospital of Central South 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:

(2020)伦审【临研】第(054)号 

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:

中南大学湘雅二医院临床研究伦理委员会 

Name of the ethic committee:

Clinical Research Ethics Committee of the Second Xiangya Hospital of Central South University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-13 

伦理委员会联系人:

徐会中 

Contact Name of the ethic committee:

Huizhong Xu 

伦理委员会联系地址:

中国湖南省长沙市人民中路139号 

Contact Address of the ethic committee:

139 Renmin Road Middle, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 731-85292476 

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:

中南大学湘雅二医院 

Primary sponsor:

The Second Xiangya Hospital of Central South University 

研究实施负责(组长)单位地址:

中国湖南省长沙市人民中路139号 

Primary sponsor's address:

139 Renmin Road Middle, Changsha, Hu'nan, 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):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

中南大学湘雅二医院

具体地址:

人民中路139号

Institution
hospital:

The Second Xiangya Hospital of Central South University

Address:

139 Renmin Road Middle

经费或物资来源:

美国中华医学基金会 

Source(s) of funding:

China Medical Board 

研究疾病:

心脏疾病 

Target disease:

Heart diseases 

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:

通过构建SMART模式对我省华法林患者进行管理,旨在提高患者使用华法林的安全性和有效性,并且提高患者生活质量。同时该研究通过与普通门诊和抗凝门诊对比,评价华法林SMART居家管理模式的有效性、安全性和经济性。 

Objectives of Study:

The purpose is to improve the safety and effectiveness of patients on warfarin as well as to improve their quality of life by establishing the SMART model to manage these patients. Meanwhile,the effectiveness, safety and cost-effectiveness of the SMART model will be evaluated by comparing with the usual care clinic and the anticoagulantion clinic. 

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 未来12个月里会持续服用华法林进行治疗; ② 服从试验方案和随机化; ③ 签署知情同意书。 

Inclusion criteria

1. Patients who will continue to take warfarin in the next 12 months; 2. Patients who followed the protocol and randomization; 3. Patients who signed informed consent. 

排除标准:

① 妊娠或在未来18个月中妊娠计划; ② 过去6个月内有因出血不良事件进行治疗; ③ 无法在6小时内到医院就诊; ④ 肾衰晚期(进行血液透析或者肾小球清除率<10mL/min); ⑤ 老年痴呆或精神分裂症; ⑥ 正在接受抗癌治疗; ⑦ 患有充血性心衰并需要接受药物治疗; ⑧ 有胃溃疡等出血病史; ⑨ 同时服用阿司匹林等抗血小板药物。 

Exclusion criteria:

1. Subjects of pregnancy or pregnancy plan in the next 18 months; 2. Those who had been treated for bleeding adverse events in the past 6 months; 3. Those who can't go to the hospital within 6 hours; 4. Patients with advanced renal failure (hemodialysis or glomerular clearance rate < 10ml / min) 5. Patients with senile dementia or schizophrenia; 6. Patients receiving anti-cancer treatment; 7. Patients with congestive heart failure who need medical treatment; 8. Patients with history of bleeding such as gastric ulcer; 9. Patients taking aspirin and other antiplatelet drugs at the same time. 

研究实施时间:

Study execute time:

From2020-01-01To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2020-11-02To 2022-10-15 

干预措施:

Interventions:

组别:

SMART组

样本量:

360

Group:

SMART group

Sample size:

干预措施:

SMART模式管理

干预措施代码:

Intervention:

SMART model management

Intervention code:

组别:

UC组

样本量:

360

Group:

usual care clinic group

Sample size:

干预措施:

不干预,常规医生门诊就诊

干预措施代码:

Intervention:

No intervention, patients will be managed in the usual care clinics

Intervention code:

组别:

AC 组

样本量:

360

Group:

anticoagulation clinic group

Sample size:

干预措施:

不干预,抗凝门诊就诊

干预措施代码:

Intervention:

No intervention, patients will be managed in the anticoagulation clinics

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

中南大学湘雅二医院 

单位级别:

三级 

Institution
hospital:

The Second Xiangya Hospital of Central South University  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

中南大学湘雅医院 

单位级别:

三级 

Institution
hospital:

The Xiangya Hospital of Central South University  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

中南大学湘雅三医院 

单位级别:

三级 

Institution
hospital:

The Third Xiangya Hosptial of Central South University  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

湖南省人民医院 

单位级别:

三级 

Institution
hospital:

Hunan Provincial People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

衡阳 

Country:

China 

Province:

Hu'nan 

City:

Hengyang 

单位(医院):

南华大学附属第一医院 

单位级别:

三级 

Institution
hospital:

The First Affiliated Hospital of South China University  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

怀化 

Country:

China 

Province:

Hu'nan 

City:

Huaihua 

单位(医院):

怀化市第一人民医院 

单位级别:

三级 

Institution
hospital:

Huaihua First People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

常德 

Country:

China 

Province:

Hu'nan 

City:

Changde 

单位(医院):

常德市第一人民医院 

单位级别:

三级 

Institution
hospital:

Changde First People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

岳阳 

Country:

China 

Province:

Hu'nan 

City:

Yueyang 

单位(医院):

岳阳市一人民医院 

单位级别:

三级 

Institution
hospital:

Yueyang First People's hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

湘潭 

Country:

China 

Province:

Hu'nan 

City:

Xiangtan 

单位(医院):

湘潭市中心医院 

单位级别:

三级 

Institution
hospital:

Xiangtan Central Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

株洲 

Country:

China 

Province:

Hu'nan 

City:

Zhuzhou 

单位(医院):

株洲市中心医院 

单位级别:

三级 

Institution
hospital:

Zhuzhou Central Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

邵阳 

Country:

China 

Province:

Hu'nan 

City:

Shaoyang 

单位(医院):

邵阳市中心医院 

单位级别:

三级 

Institution
hospital:

Shaoyang Central Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

湖南 

市(区县):

桃源 

Country:

China 

Province:

Hu'nan 

City:

Taoyuan 

单位(医院):

桃源县人民医院 

单位级别:

二级甲等 

Institution
hospital:

Taoyuan People's Hospital  

Level of the institution:

Secondary A 

国家:

中国 

省(直辖市):

湖南 

市(区县):

平江 

Country:

China 

Province:

Hu'nan 

City:

Pingjiang 

单位(医院):

平江县人民医院 

单位级别:

二级甲等 

Institution
hospital:

Pingjiang People's Hospital  

Level of the institution:

Secondary A 

国家:

中国 

省(直辖市):

湖南 

市(区县):

宁乡 

Country:

China 

Province:

Hu'nan 

City:

Ningxiang 

单位(医院):

宁乡县人民医院 

单位级别:

二级甲等 

Institution
hospital:

Ningxiang People's Hospital  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

TTR(治疗范围内时间百分比)

指标类型:

主要指标 

Outcome:

The percentage of time in therapeutic range

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

INR <1.5 的次数

指标类型:

次要指标 

Outcome:

the numbers of INR results <1.5

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

INR >5.0 的次数

指标类型:

次要指标 

Outcome:

the numbers of INR results >5.0

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

严重不良事件

指标类型:

次要指标 

Outcome:

serious adverse clinical events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者生活质量

指标类型:

次要指标 

Outcome:

patients’ quality of life

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:

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:

大便

组织:

Sample Name:

stool

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 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):

随机化方法将由各中心负责人利用互联网程序实现(网址:(http://stattrek.com/statistics/random-number-generator.aspx))

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

Patients’ randomization will be carried out using a standard protocol available on the internet (http://stattrek.com/statistics/random-number-generator.aspx).

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):

是否共享原始数据:

IPD sharing

是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):

2024年公开原始数据,上传数据到中国临床试验注册中心

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

In 2024, the original data will be uploaded into the Chinese clinical trial registry

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:

采用病例记录表和Resman对数据进行采集和管理

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

Data collection and management will be conducted by case record form and Resman.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-11
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