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微信健康教育在强直性脊柱炎患者中的应用效果研究
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注册号:

Registration number:

ChiCTR-IPR-16009293 

最近更新日期:

Date of Last Refreshed on:

2016-09-29 

注册时间:

Date of Registration:

2016-09-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

微信健康教育在强直性脊柱炎患者中的应用效果研究 

Public title:

A study of the application of WeChat-based health education in patients with ankylosing spondylitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

微信健康教育在强直性脊柱炎患者中的应用效果研究 

Scientific title:

A study of the application of WeChat-based health education in patients with ankylosing spondylitis 

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:

宋雨晴 

研究负责人:

陈红 

Applicant:

Song Yuqing 

Study leader:

Chen Hong 

申请注册联系人电话:

Applicant telephone:

+86 13258288267 

研究负责人电话:

Study leader's telephone:

+86 18980601733 

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:

13258288267@163.com 

研究负责人电子邮件:

Study leader's E-mail:

1366109878@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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxuexiang, Chengdu, Sichuan, China  

Study leader's address:

37 Guoxuexiang, Chengdu, Sichuan, China  

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区国学巷37号 

Primary sponsor's address:

37 Guoxuexiang, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西医院

具体地址:

四川省成都市武侯区国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxuexiang, Chengdu, Sichuan, China

经费或物资来源:

四川大学华西医院 

Source(s) of funding:

West China Hospital, Sichuan University 

研究疾病:

ankylosing spondylitis 

Target disease:

强直性脊柱炎 

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:

1.评估微信健康教育方案的可行性和应用效果;2.为开展强直性脊柱炎出院患者的健康教育提供依据,进一步改善患者结局。 

Objectives of Study:

1. To evaluate the validity and the feasibility of telephone follow-up health education; 2. To provide an effective health education program for patients with ankylosing spondylitis and improve their outcomes. 

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.诊断符合1984年纽约强直性脊柱炎分类标准;2.年龄≥14岁;3.意识清楚,有一定的阅读理解和言语表达能力;4.自愿参加本研究。 

Inclusion criteria

1. Confirmed ankylosing spondylitis by Modified New York criteria for ankylosing spondylitis (1984); 2. Aged more than 14 years old, either two genders; 3. To be able to conscious, understand and express Chinese; 4. Volunteer to participate in the study. 

排除标准:

1.有严重的认知或精神障碍者;2.不使用微信者;3.正在参与其他健康教育类的研究项目。 

Exclusion criteria:

1. Patient with severe cognitive or mental impairment; 2. Not use WeChat; 3. Are participating in other health education programs. 

研究实施时间:

Study execute time:

From2016-10-10To 2017-12-01 

征募观察对象时间:

Recruiting time:

From2016-10-10To  

干预措施:

Interventions:

组别:

干预组

样本量:

51

Group:

Intervention group

Sample size:

干预措施:

基于微信的健康教育

干预措施代码:

Intervention:

WeChat-based health education

Intervention code:

组别:

对照组

样本量:

51

Group:

Control group

Sample size:

干预措施:

常规护理

干预措施代码:

Intervention:

Standard care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西医院 

单位级别:

三级甲等医院 

Institution
hospital:

West China Hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

强直性脊柱炎患者疾病知识问卷

指标类型:

主要指标 

Outcome:

The AS knowledge questionnaire

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

关节炎自我效能量表

指标类型:

主要指标 

Outcome:

Arthritis Self—Efficacy Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Morisky 服药依从性量表

指标类型:

主要指标 

Outcome:

Morisky Medication Adherence Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

巴氏强直性脊柱炎疾病活动指数

指标类型:

次要指标 

Outcome:

Bath Ankylosing Spondylitis Disease Activity Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

巴氏强直性脊柱炎功能指数

指标类型:

次要指标 

Outcome:

Bath Ankylosing Spondylitis Functional Index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

强直性脊柱炎生活质量量表

指标类型:

次要指标 

Outcome:

Ankylosing?Spondylitis?Quality?of?Life Questionnaire

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 14 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):

研究者用电脑生成的随机数字表将受试者随机分为对照组和干预组

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

Randomly divide the participants into control group or intervention group with a computer generated random number table by the researcher

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):

是否共享原始数据:

IPD sharing

否No

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-09-29
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