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: |
|
||||||||||||||||||||||
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: |
0 |
||||||||||||||||||||||
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: |
从From2016-10-10至To 2017-12-01 |
征募观察对象时间: Recruiting time: |
从From2016-10-10至To |
干预措施: Interventions: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|
采集人体标本:
Collecting sample(s)
|
|
征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
|
||||||
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
|
|
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 |