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基于SNA的基本公共卫生服务运行机制优化关键技术研究
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注册号:

Registration number:

ChiCTR1900020753 

最近更新日期:

Date of Last Refreshed on:

2019-01-17 

注册时间:

Date of Registration:

2019-01-17 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于SNA的基本公共卫生服务运行机制优化关键技术研究  

Public title:

Study for the key technologies for optimization of the basic public health services operating mechanism based on SNA  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于SNA的基本公共卫生服务运行机制优化关键技术研究  

Scientific title:

Study for the key technologies for optimization of the basic public health services operating mechanism based on SNA  

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:

励晓红 

研究负责人:

励晓红 

Applicant:

Xiaohong Li 

Study leader:

Xiaohong Li 

申请注册联系人电话:

Applicant telephone:

+86 13918213586 

研究负责人电话:

Study leader's telephone:

+86 13918213586 

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:

lixiaohongfudan@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lixiaohongfudan@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:

上海市医学院路138号177信箱 

研究负责人通讯地址:

上海市医学院路138号177信箱 

Applicant address:

P.O. Box 177, 138 Yi-Xue-Yuan Road, Shanghai, China 

Study leader's address:

P.O. Box 177, 138 Yi-Xue-Yuan Road, Shanghai, 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:

复旦大学 

Applicant's institution:

Fudan 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:

IRB#2018-01-0663 

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:

复旦大学公共卫生学院医学研究伦理委员会 

Name of the ethic committee:

Medical research ethics committee, School of public health, Fudan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-01-24 

伦理委员会联系人:

罗君 

Contact Name of the ethic committee:

Luo Jun 

伦理委员会联系地址:

上海市徐汇区医学院路138号复旦大学公共卫生学院科研办  

Contact Address of the ethic committee:

Scientific Research Office of School of Public Health, Fudan University, 138 Medical College Road, Xuhui District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-54237051 

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:

复旦大学 

Primary sponsor:

Fudan University 

研究实施负责(组长)单位地址:

上海市医学院路138号 

Primary sponsor's address:

138 Yi-Xue-Yuan Road, Shanghai, 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):

上海

市(区县):

徐汇区

Country:

China

Province:

Shanghai

City:

Xuhui District

单位(医院):

复旦大学公共卫生学院

具体地址:

上海市东安路130号

Institution
hospital:

School of Public Health Fudan University

Address:

130 Dong'an Road, Shanghai 20032, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

The National Natural Science Fund  

研究疾病:

意外伤害 

Target disease:

Accidental injury 

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:

研究针对优化服务运行所需,一是研制“细化服务内容机制、优化服务提供过程机制、优化运行评估指标体系机制”关键技术,结合糖尿病健康教育和婴幼儿健康管理服务,基于社会网络分析、社会营销等理论方法,阐述关键技术在优化具体服务运行机制中的运用;二是结合两类服务的运行机制,形成干预方案,开展干预研究,全过程记录实施过程中解决难点与障碍的办法;三是运用多水平模型、重复测量方差分析等方法,对干预过程和结果进行评价,并完善关键技术。最终形成一套现实可操作的包括关键技术及其应用评价的理论体系及操作指南,对其他地区如何优化服务运行也有思路和方法上的借鉴意义。 儿童意外伤害干预将作为本研究子项目之一,探讨基于微信群的社区干预方案对儿童意外伤害发生率、儿童家长的意外伤害风险意识、知识、行为的改善情况。 

Objectives of Study:

In order to optimize the implementation of the basic public health services, this study aims to develop three key technologies: the mechanism of detailing the content of the services, the mechanism of optimizing the providing process of services, and mechanism of optimizing the operation evaluation system. This study selects the services of health education on diabetes and the services of health management of the 0-3 years, and explores new interventions based on the theories and methods of social network analysis and social marketing. This study will carry out a controlled community-based intervention study, and record the resolution for the difficulties and obstacles during the program. The process and outcome of the intervention study will be evaluated, using methods such as multi-level modeling and repeated measures analysis of variance. Furthermore, the key technologies will be improved based on the evaluation. A guideline will be formed, including technologies and their application. The results of this study will provide references for optimization of the implementation of other public health services at other places in terms of framework and methods. Child accidental injury intervention will be one of the sub-projects of this study.Child accidental injury intervention will be one of the sub-projects of this study to explore the effect of WeChat-based community intervention regimen on incidence rate of unintentional injuries in children, and on improvement of parentsperception, knowledge and behavior of unintentional injury risk  

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:

1.0-3岁儿童的儿童家长; 2.父母为其主要照顾人之一; 3.父母经常使用微信; 4.识字且文化程度是初中或初中以上; 5.儿童身心健康、未见明显疾病或残疾; 6.儿童父母对本课题知情同意,自愿签署知情同意书。 7.近一年内无搬迁计划。 

Inclusion criteria

1. parents whose child is 0-3 years of age; 2. mother or father is one of primary caregivers; 3. parents are frequent WeChat user; 4. parents went to at least junior high school; 5. the child is physically and mentally healthy; absence of apparent disease or disabilities; 6. parents of the child were informed, and signed on the informed consent on a volunteer basis; 7. no recent plans of move. 

排除标准:

1.排除不符合纳入标准者; 2.排除资料不全或难以配合治疗者; 3.存在智力问题者; 4.不愿意或无法提供知情同意; 5.正在参与其他儿童意外伤害干预研究。 

Exclusion criteria:

1. participants who do not meet the inclusion criteria; 2. participants with incomplete information or bad compliance; 3. participants who have intellectual illness; 4. unwilling or unable to provide informed consent; 5. Participating in other accidental injury intervention studies.  

研究实施时间:

Study execute time:

From2016-01-01To 2020-02-29 

征募观察对象时间:

Recruiting time:

From2019-01-27To 2019-02-28 

干预措施:

Interventions:

组别:

干预组

样本量:

155

Group:

intervention group

Sample size:

干预措施:

微信干预

干预措施代码:

Intervention:

WeChat intervention

Intervention code:

组别:

对照组

样本量:

155

Group:

control group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市嘉定区嘉定镇社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Community Health Service Center of Jiading Town, Jiading District, Shanghai  

Level of the institution:

Community Health Service Center  

测量指标:

Outcomes:

指标中文名:

意外伤害发生率

指标类型:

主要指标 

Outcome:

Incidence of accidental injury

Type:

Primary 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 18 years
最大 Max age 79 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):

使用计算机软件进行随机化分组,分组后儿童家长进入干预组或对照组

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

Randomized grouping was performed by computer software. After grouping,parents of children were paired into intervention group or control group.

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

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):

本课题组于本临床试验所获原始数据将于本试验结束后6个月内在中国临床试验注册中心(http://www.chictr.org.cn/index.aspx)进行共享

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

The original data collected in this study will be shared in 6 months after the end of this study at the China Clinical Trials Registry (http://www.chictr.org.cn/index.aspx).

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:

http://www.medresman.org

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

http://www.medresman.org

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:

 2019-01-17
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