ChiCTR2400086768 版本V1.0 版本创建时间2024/07/10 14:25:53 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400086768 

最近更新日期：

Date of Last Refreshed on：

 2024-07-10 14:25:48 

注册时间：

Date of Registration：

 2024-07-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

儿童抗菌药物合理使用校园众创干预研究

Public title：

Crowdsourcing to Improve Antibiotic Use among Children in China: a School-based, Open-label, Clusterr Randomized, Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于认知社会影响理论的儿童抗菌药物合理使用校园众创干预研究

Scientific title：

School-based Crowdsourcing to Improve Antibiotic Use among Children Based on Cognitive-Social Impact Theory: An Open-label, Cluster 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：

徐锌 

研究负责人：

周旭东 

Applicant：

Xin Xu 

Study leader：

Xudong Zhou 

申请注册联系人电话：

Applicant telephone：

 +86 188 6810 9091

研究负责人电话：

Study leader's
telephone：

+86 181 5810 1668

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：

 zinc_xu@zju.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 zhouxudong@zju.edu.cn

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：

浙江省杭州市西湖区余杭塘路866号浙江大学紫金港校区

研究负责人通讯地址：

浙江省杭州市西湖区余杭塘路866号浙江大学紫金港校区

Applicant address：

Zhejiang University, 866 Yuhangtang Road, Xihu District, Hangzhou, Zhejiang Province, 310058, P.R.China

Study leader's address：

Zhejiang University, 866 Yuhangtang Road, Xihu District, Hangzhou, Zhejiang Province, 310058, P.R.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：

浙江大学

Applicant's institution：

Zhejiang University

研究负责人所在单位：

浙江大学

Affiliation of the Leader：

Zhejiang 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：

 ZGL202401-2

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：

浙江大学公共卫生学院医学伦理委员会

Name of the ethic committee：

Ethics Committee of Zhejiang University School of Public Health

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-01-25 00:00:00

伦理委员会联系人：

李佳

Contact Name of the ethic committee：

Jia Li

伦理委员会联系地址：

杭州市西湖区余杭塘路866号浙江大学紫金港校区医学院综合楼907

Contact Address of the ethic committee：

Room 907, Comprehensive Building, School of Medicine, Zijingang Campus, Zhejiang University, 866 Yuhangtang Road, Xihu District, Hangzhou, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 8898 1319

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：

浙江大学

Primary sponsor：

Zhejiang University

研究实施负责（组长）单位地址：

浙江省杭州市西湖区余杭塘路866号浙江大学紫金港校区

Primary sponsor's address：

Zhejiang University, 866 Yuhangtang Road, Xihu District, Hangzhou, Zhejiang Province, 310058, P.R.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)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江大学

具体地址：

浙江省杭州市西湖区余杭塘路866号浙江大学紫金港校区

Institution
hospital：

Zhejiang University

Address：

Zhejiang University, 866 Yuhangtang Road, Xihu District, Hangzhou, Zhejiang Province, 310058, P.R.China

经费或物资来源：

国家自然科学基金（项目号：82373693）

Source(s) of funding：

Natural Science Foundation of China (NSFC), No. 82373693

研究疾病：

无  

Target disease：

NA

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

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

1）验证基于认知-社会影响理论的校园众创健康教育的有效性； 1.1）主要研究问题：校园众创健康教育是否能有效减少儿童家长的自我治疗使用抗菌药物行为。 1.2）次要研究问题：校园众创健康教育是否能有效改善参与儿童及儿童家长其他使用抗菌药物的行为、对抗菌药物的认知和使用技能。 2）开展校园众创健康教育的经济学评估； 3）探究认知-社会影响理论对抗菌药物使用行为改变的路径。  

Objectives of Study：

1) To validate the effectiveness of campus crowdsourced health education based on cognitive-social influence theory; 1.1) Primary research question: whether campus crowdsourced health education is effective in reducing self-medicating antimicrobial drug use behaviours among children's parents. 1.2) Secondary research question: whether campus crowdsourced health education is effective in improving other antimicrobial drug use behaviours, perceptions of antimicrobial drugs, and use skills of participating children and children's parents. 2) To conduct an economic evaluation of campus-based crowd-sourced health education; 3) To explore the pathways of Cognitive-Social Influence Theory for behavioural change in antimicrobial drug use.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

整群纳排标准 在本研究中，每所学校视为一个集群。纳入本研究的集群应当符合以下条件： 1）在学校层面签署了知情同意书； 2）与任意其他小学/校区地理位置距离2千米以上； 3）选择小学3-5年级或初中1-2年级学生总人数大于100； 个体纳排标准 在本研究中，参与的学生及学生的一个家长（主要照顾者）视为个体。纳入本研究的个体应当符合以下条件： 1）学生与至少1名家长共同生活； 2) 学生本人及家长在个体层面签署了知情同意书； 3）学生本人正常就读于纳入研究的小学3-5年级或初中1-2年级，排除在研究进行期间休学，转学等非正常就读状态的学生； 4）学生本人及家长有能力完成校园众创健康教育的创作及研究评估；

Inclusion criteria

Cluster Inclusion/Exclusion Criteria For the purposes of this study, each school is considered a cluster. Clusters included in this study should meet the following criteria: 1) Signed informed consent at the school level; 2) Geographically located more than 2 km away from any other primary school/school district; 3) Selection of primary school grades 3-5 or junior high school grades 1-2 with a total number of students greater than 100; Individual Inclusion/Exclusion Criteria For the purpose of this study, participating students and one of the students' parents (primary caregiver) are considered individuals. Individuals included in this study should meet the following criteria: 1) The student lives with at least 1 parent; 2) The student himself/herself and his/her parent(s) have signed an informed consent form at the individual level; 3) The student was enrolled in grades 3-5 of the primary school or grades 1-2 of the junior high school in which the study was conducted, excluding students who were suspended from school, transferred to another school, or were not enrolled in school at the time of the study; (4) The students themselves and their parents are capable of completing the creation and evaluation of the study on crowdsourcing health education in schools;

排除标准：

整群纳排标准 在本研究中，每所学校视为一个集群。纳入本研究的集群应当符合以下条件： 1）在学校层面签署了知情同意书； 2）与任意其他小学/校区地理位置距离2千米以上； 3）选择小学3-5年级或初中1-2年级学生总人数大于100； 个体纳排标准 在本研究中，参与的学生及学生的一个家长（主要照顾者）视为个体。纳入本研究的个体应当符合以下条件： 1）学生与至少1名家长共同生活； 2) 学生本人及家长在个体层面签署了知情同意书； 3）学生本人正常就读于纳入研究的小学3-5年级或初中1-2年级，排除在研究进行期间休学，转学等非正常就读状态的学生； 4）学生本人及家长有能力完成校园众创健康教育的创作及研究评估；

Exclusion criteria：

Cluster Inclusion/Exclusion Criteria For the purposes of this study, each school is considered a cluster. Clusters included in this study should meet the following criteria: 1) Signed informed consent at the school level; 2) Geographically located more than 2 km away from any other primary school/school district; 3) Selection of primary school grades 3-5 or junior high school grades 1-2 with a total number of students greater than 100; Individual Inclusion/Exclusion Criteria For the purpose of this study, participating students and one of the students' parents (primary caregiver) are considered individuals. Individuals included in this study should meet the following criteria: 1) The student lives with at least 1 parent; 2) The student himself/herself and his/her parent(s) have signed an informed consent form at the individual level; 3) The student was enrolled in grades 3-5 of the primary school or grades 1-2 of the junior high school in which the study was conducted, excluding students who were suspended from school, transferred to another school, or were not enrolled in school at the time of the study; (4) The students themselves and their parents are capable of completing the creation and evaluation of the study on crowdsourcing health education in schools;

研究实施时间：

Study execute time：

从 From 2024-07-15 00:00:00至 To 2025-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-07-15 00:00:00 至 To 2024-08-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 3136

Group：

Intervention Group

Sample size：

干预措施：

在干预组开展以细菌耐药和抗菌药物合理使用为主题的众创健康教育干预，形式类似一次科普材料创作征集大赛。众创健康教育过程包括抗菌药物合理使用设计征集、任务创作、专家评审、大众评审、决赛评选和健康教育六个步骤。

干预措施代码：

Intervention：

A crowdsourcing health education intervention on the theme of antimicrobial resistance and the rational use of antimicrobials will be conducted in the intervention group in a format similar to a contest for the creation of popular science materials. The crowdsourced health education process will include six steps: antimicrobial rational use design call, task creation, expert review, public review, final selection and health education.

Intervention code：

组别：

对照组

样本量：

 3136

Group：

Control Group

Sample size：

干预措施：

对照组将举行无关主题（以“非洲文化”为主题）的材料征集比赛

干预措施代码：

Intervention：

In the control group, a contest will be held to collect materials on an unrelated theme (on the theme of "African culture").

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 南陵 

Country：

China

Province：

Anhui

City：

Nanling

单位(医院)：

 南陵县28所小学或初中 

单位级别：

 小学或初中 

Institution
hospital：

28 primary or junior secondary schools in Nanling

Level of the institution：

primary or junior secondary schools

测量指标：

Outcomes：

指标中文名：

儿童家长为孩子自我治疗使用抗菌药物行为

指标类型：

主要指标

Outcome：

Parents’ self-medication with antimicrobial for their children

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

家长及孩子抗菌药物知识水平

指标类型：

次要指标

Outcome：

Parents' and children's antimicrobial knowledge level

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

儿童家长其他抗菌药物使用行为

指标类型：

次要指标

Outcome：

Parents‘ other antimicrobial use behaviours

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

儿童家长使用抗菌药物的技能水平

指标类型：

次要指标

Outcome：

Parents‘ skill level of antimicrobial use

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：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

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 8 岁 years
最大 Max age 80 岁 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）：

本研究采用分层随机。随机过程由一个独立的研究人员（不参与本研究）通过SAS或者R生成随机种子数完成。28所学校先按照学校类型（小学/初中）和城乡（城市/农村）进行分层，每一层中的学校按照1：1随机分入干预组或对照组。

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

Stratified randomisation will be used in this study. The randomisation process was completed by an independent researcher (not involved in this study) by generating random seed numbers through SAS or R. The 28 schools will be first stratified by school type (primary/junior high school) and urban/rural (urban/rural), and schools in each stratum were randomised 1:1 into either the intervention or control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

本研究为开放标签设计，但进行以下盲法处理： 1）参与随机分组的研究人员不参与干预设计、干预实施、数据收集和分析； 2）辅助研究进行的工作人员（如学校领导，班主任等）及参与研究的学生及学生家长将被告知本研究的目的是“中小学生全球领导力项目”，虽然他们知道有两个主题的比赛，但是他们可能不知道自己参与了一项随机对照试验，不了解问卷调查与主题比赛间的关联。问卷内容将包括抗菌药物使用、非洲文化及儿童领导力相关的条目。 3）所有数据收集工作均在第三方在线平台上进行，负责数据分析的研究人员在数据分析结果确定前不知道分组情况，也不会和任何研究对象接触。

Blinding：

The study is an open-label trial but following blinded treatments will be performed: (1) Researchers involved in the randomization will not be involved in the intervention design, intervention implementation, data collection and analysis; 2) Staff supporting the conduct of the study (e.g., school leaders, classroom teachers, etc.) and students and parents of students participating in the study will be informed that the purpose of the study is a "global leadership programme for primary and secondary school students", and that although they are aware of the two themed competitions, they may not be aware that they are participating in a randomised controlled trial, and are unaware of the evaluation questionnaire will be linked to the themed competitions. The questionnaire will include entries related to antimicrobial drug use, African culture and child leadership. 3) All data collection will take place on a third party online platform and the researcher responsible for data analysis will not be aware of the subgroups until the results of the data analysis have been finalised and will not be in contact with any of the study participants.

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）：

不共享原始数据

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

Not sharing

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：

问卷数据通过第三方在线平台（问卷星）采集，由数据管理人员进行管理。

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

Questionnaire data will be collected through a third-party online platform (Questionstar) and managed by a data manager.

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：

  2024-07-10 14:25:48