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远程医疗在骨关节炎中的应用:一项随机对照试验
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注册号:

Registration number:

ChiCTR1800014465 

最近更新日期:

Date of Last Refreshed on:

2018-01-16 

注册时间:

Date of Registration:

2018-01-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

远程医疗在骨关节炎中的应用:一项随机对照试验  

Public title:

Implementation of telemedicine for knee osteoarthritis: a randomized controlled trial  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

远程医疗在骨关节炎中的应用:一项随机对照试验  

Scientific title:

Implementation of telemedicine for knee osteoarthritis: a randomized controlled trial  

研究课题代号(代码):

Study subject ID:

院内青年基金 (编号:YQ2016-006) ;人才发展基金(编号:2014001) ;广东省自然科学基金 (编号:2017A030313526)  

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:

黄正平 

研究负责人:

黄正平 

Applicant:

Huang Zhengping 

Study leader:

Huang Zhengping 

申请注册联系人电话:

Applicant telephone:

+86 13802416733 

研究负责人电话:

Study leader's telephone:

+86 13802416733 

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:

huangzhp2012@163.com 

研究负责人电子邮件:

Study leader's E-mail:

huangzhp2012@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:

广东省广州市海珠区新港中路466号 

研究负责人通讯地址:

广东省广州市海珠区新港中路466号 

Applicant address:

466 Xin'gang Middle Road, Haizhu District, Guangzhou, Guangdong, China 

Study leader's address:

466 Xin'gang Middle Road, Haizhu District, Guangzhou, Guangdong, 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:

广东省第二人民医院 

Applicant's institution:

Guangdong Second Provincial General Hospital  

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:

2017-SF-032 

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:

广东省第二人民医院伦理委员会 

Name of the ethic committee:

Guangdong Second Provincial General Hospital ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

田军章 

Contact Name of the ethic committee:

Tian Junzhang 

伦理委员会联系地址:

广东省广州市海珠区新港中路466号 

Contact Address of the ethic committee:

466 Xin'gang Middle Road, Haizhu District, Guangzhou, Guangdong, 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:

广东省第二人民医院 

Primary sponsor:

Guangdong Second Provincial General hospital  

研究实施负责(组长)单位地址:

广东省广州市海珠区新港中路466号 

Primary sponsor's address:

466 Xin'gang Middle Road, Haizhu District, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省第二人民医院

具体地址:

广东省广州市海珠区新港中路466号

Institution
hospital:

Guangdong Second Provincial General hospital

Address:

466 Xin'gang Middle Road, Haizhu District, Guangzhou, Guangdong, China

经费或物资来源:

院内青年基金 (编号:YQ2016-006) ;人才发展基金(编号:2014001) ;广东省自然科学基金 (编号:2017A030313526)  

Source(s) of funding:

the Youth Development Foundation (Grant No. YQ2016-006); the Talent Development Fund (Grant No. 2014001); Natural Science Foundation of Guangdong Province, China (Grant No.2017A030313526) 

研究疾病:

膝骨关节炎 

Target disease:

Knee osteoarthritis 

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:

评估广东省网络医院强化膝骨关节炎管理的可能性和有效性  

Objectives of Study:

To evaluate the feasibility and efficacy of Guangdong Internet Hospital in enhanced management of knee osteoarthritis  

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:

符合1986年ACR膝骨关节炎分类标准;单侧膝骨关节炎;VAS>20mm,持续6个月;50-75岁;所在社区有广东省网络医院平台;有交流和理解能力  

Inclusion criteria

Participants will be qualified for inclusion when they meet the following criteria: meeting the 1986 American College of Rheumatology (ACR) classification criteria for knee OA; unilateral knee OA with a pain score of at least 20 mm on a 100-mm visual analogue scale (VAS) for at least 6 months; aged 50 to 75 years on the date of invitation to participate; availability of GOH telemedicine platforms in the community; ability to communicate and to understand the study.  

排除标准:

严重的关节残疾,需要手术;其他关节疾病,如类风湿关节炎、关节外伤;自身免疫病及其他系统慢性疾病;不同意进行该研究;无法访问广东省网络医院平台  

Exclusion criteria:

Participants will be excluded if they have any of the following conditions: OA with severe joint deformity which needs surgery; other joint diseases, including rheumatoid arthritis and joint trauma; autoimmune diseases; hypertension; coronary heart disease; chronic digestive disorders including chronic gastritis and chronic hepatitis; stroke; diabetes mellitus; chronic kidney diseases; chronic respiratory diseases including chronic obstructive pulmonary disease; cancers; dementia or substantial cognitive impairment; psychotic illness; inability to give informed consent; unable to communicate or to understand the study; and no access to a GOH telemedicine platform.  

研究实施时间:

Study execute time:

From2018-02-01To 2019-06-30 

干预措施:

Interventions:

组别:

干预组

样本量:

20

Group:

Intervention group

Sample size:

干预措施:

常规管理的基础上通过广东省网络医院进行强化管理

干预措施代码:

Intervention:

In addition to conventional therapy, participants in CT-GOHT group will receive a brief repeated GOH-based management every month via the GOHT platform.

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

常规药物治疗

干预措施代码:

Intervention:

conventional therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Second Provincial General hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

可行性

指标类型:

主要指标 

Outcome:

Feasibility

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

麦克马斯特大学骨关节炎指数

指标类型:

次要指标 

Outcome:

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医院焦虑和抑郁量表

指标类型:

次要指标 

Outcome:

Hospital Anxiety and Depression Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数

指标类型:

次要指标 

Outcome:

the Pittsburgh Sleep Quality Index (PSQI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

多维疲劳量表

指标类型:

次要指标 

Outcome:

the Multidimensional Fatigue Inventory (MFI)

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:

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 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):

随机数字表法

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

Random number table

盲法:

Blinding:

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2020年1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 2020 in the form of meetings, speeches or 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)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:

 2018-01-16
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