基于决策树的消化性溃疡诊疗互动视频课程开发与效果评价

注册号:

Registration number:

ChiCTR2300073773 

最近更新日期:

Date of Last Refreshed on:

2023-09-16 20:27:50 

注册时间:

Date of Registration:

2023-07-20 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于决策树的消化性溃疡诊疗互动视频课程开发与效果评价

Public title:

Development and effectiveness evaluation of interactive video course for diagnosis and treatment of peptic ulcer based on decision tree

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于决策树的消化性溃疡诊疗互动视频课程开发与效果评价

Scientific title:

Development and effectiveness evaluation of interactive video course for diagnosis and treatment of peptic ulcer based on decision tree

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:

吴一波 

研究负责人:

张瑞红 

Applicant:

Wu Yibo 

Study leader:

Zhang Ruihong 

申请注册联系人电话:

Applicant telephone:

+86 188 1016 9630

研究负责人电话:

Study leader's
telephone:

+86 139 3139 1449

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:

bjmuwuyibo@outlook.com

研究负责人电子邮件:

Study leader's E-mail:

425748906@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:

北京市海淀区学院路38号北京大学医学部公共卫生学院

研究负责人通讯地址:

保定市第四中心医院

Applicant address:

School of Public Health, Peking University Health Science Center, 38 Xueyuan Road, Haidian District, Beijing

Study leader's address:

Baoding Fourth Central Hospital, 28 Xiangyang Street North, Tangxian County, Baoding, Hebei

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:

北京大学医学部公共卫生学院社会医学与健康教育系

Applicant's institution:

Department of Social Medicine and Health Education, School of Public Health, Peking University

研究负责人所在单位:

保定市第四中心医院

Affiliation of the Leader:

Baoding Fourth Central Hospital

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2023031

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:

保定市第四中心医院伦理委员会

Name of the ethic committee:

Ethics Committee of Baoding Fourth Central Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2023-05-08 00:00:00

伦理委员会联系人:

赵文娟

Contact Name of the ethic committee:

Zhao Wenjuan

伦理委员会联系地址:

河北省保定市唐县向阳北街28号

Contact Address of the ethic committee:

28 Xiangyang Street North, Tangxian County, Baoding, Hebei

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 159 3075 8855

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:

保定市第四中心医院

Primary sponsor:

Baoding Fourth Central Hospital

研究实施负责(组长)单位地址:

河北省保定市唐县向阳北街28号

Primary sponsor's address:

28 Xiangyang Street North, Tangxian County, Baoding, Hebei

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河北

市(区县):

保定市

Country:

China

Province:

Hebei

City:

Baoding

单位(医院):

保定市第四中心医院

具体地址:

唐县向阳北街28号

Institution
hospital:

Baoding Fourth Central Hospital

Address:

28 Xiangyang Street North, Tangxian County

经费或物资来源:

自筹

Source(s) of funding:

self-funded

研究疾病:

教学改革  

Target disease:

Teaching Reform

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:

随机平行对照 

Study design:

Parallel 

研究目的:

将互动视频技术应用在消化性溃疡教学中,以期改善学生的学习效果、提升课程质量。  

Objectives of Study:

The application of interactive video technology in the teaching of peptic ulcer aims to improve students' learning outcomes and enhance course quality.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

排除标准: 1.有重大身体或心理疾病者,比如重度抑郁; 2.正在参与其他类似研究课题者。

Exclusion criteria:

Exclusion criteria: 1. People with serious physical or psychological diseases, such as severe depression; 2. Those who are participating in other similar research projects.

研究实施时间:

Study execute time:

From 2023-06-01 00:00:00 To 2024-02-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-08-01 00:00:00 To 2023-08-30 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

28

Group:

intervention group

Sample size:

干预措施:

利用互动视频决策树模式进行案例教学

干预措施代码:

Intervention:

Using Interactive Video Decision Tree Mode for Case Teaching

Intervention code:

组别:

对照组

样本量:

28

Group:

Control group

Sample size:

干预措施:

采用传统的CBL常规案例教学方式进行学习

干预措施代码:

Intervention:

Adopting traditional CBL conventional case teaching methods for learning

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

河北 

市(区县):

保定市 

Country:

China

Province:

Heibei

City:

Baoding

单位(医院):

保定市第四中心医院 

单位级别:

三级 

Institution
hospital:

Baoding Fourth Central Hospital

Level of the institution:

Tertiary

测量指标:

Outcomes:

指标中文名:

教学效果

指标类型:

主要指标

Outcome:

Evaluation of teaching effectiveness

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

教学满意度

指标类型:

次要指标

Outcome:

Satisfaction assessment

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

参与度评估

指标类型:

次要指标

Outcome:

Participation evaluation

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

课程体验量表(CEQ)

指标类型:

次要指标

Outcome:

Course Experience Questionnaire (CEQ)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学习效果评价量表(CBL)

指标类型:

次要指标

Outcome:

Learning Effectiveness Evaluation Scale (CBL)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

学业自我效能量表

指标类型:

次要指标

Outcome:

Academic Self Efficacy 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:

大学生学习倦怠成因问卷

指标类型:

附加指标

Outcome:

Questionnaire on the Causes of Learning Burnout among College Students

Type:

Additional 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:

组织:

Sample Name:

N/A

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 18 years
最大 Max age 22 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):

对56名在校临床医学专业学生进行方便抽样。使用计算机随机数生成器将他们按1:1的比例分为干预组和对照组,并接受干预。

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

Convenient sampling was conducted on 56 students majoring in clinical medicine on campus. They were divided into intervention group and control group according to 1:1 ratio by using computer random number generator, and received intervention.

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:

Blinding:

None

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):

公开原始数据日期2024-3,应用ResMan平台共享原始数据(www.medresman.org)

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

The original data was published on March 2024, and the original data was shared by the ResMan platform (www.medresman. org).

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:

所有的研究结果,包括临床和试验室数据,都将记录在受试者的医疗记录和病例报告表(CRF)中。研究者负责确保CRF的所有部分都正确完成,并可以根据源数据进行验证。每个完成的CRF必须注明日期并签字。一份原始CRF的副本将被转移给试验首席研究员。最初的CRF将留给调查人员。研究者将将所有试验数据(受试者识别代码列表、源数据和研究者文件)和相关通信存档在研究数据库文件中。数据库所有来源数据和该研究的所有相关文件将在试验定稿后根据法律法规存档。

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

All research results, including clinical and laboratory data, will be recorded in the subjects' medical records and case report forms (CRF). Researchers are responsible for ensuring that all parts of the CRF are completed correctly and can be validated based on source data. Each completed CRF must be dated and signed. A copy of the original CRF will be transferred to the trial Principal investigator. The initial CRF will be left to investigators. The researcher will archive all experimental data (subject identification code list, source data, and researcher files) and related communication in the research database file. All source data in the database and all relevant documents of the study will be archived in accordance with laws and regulations after the trial is finalized.

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:

 2023-07-20 14:58:51