The effectiveness of a school-based protocol for environmental cleaning and disinfection during a pandemic: a randomized controlled pilot study

注册号:

Registration number:

ChiCTR2200066239 

最近更新日期:

Date of Last Refreshed on:

2022-11-29 11:26:52 

注册时间:

Date of Registration:

2022-11-29 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

The effectiveness of a school-based protocol for environmental cleaning and disinfection during a pandemic: a randomized controlled pilot study

Public title:

The effectiveness of a school-based protocol for environmental cleaning and disinfection during a pandemic: a randomized controlled pilot study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

The effectiveness of a school-based protocol for environmental cleaning and disinfection during a pandemic: a randomized controlled pilot study

Scientific title:

The effectiveness of a school-based protocol for environmental cleaning and disinfection during a pandemic: a randomized controlled pilot study

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:

Or Pui Lai Peggy 

研究负责人:

Or Pui Lai Peggy 

Applicant:

Or Pui Lai Peggy 

Study leader:

Or Pui Lai Peggy 

申请注册联系人电话:

Applicant telephone:

85294693255

研究负责人电话:

Study leader's
telephone:

85294693255

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:

peggyor@eduhk.hk

研究负责人电子邮件:

Study leader's E-mail:

peggyor@eduhk.hk

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:

10 Lo Ping Road, Tai Po, New Territories, Hong Kong. The Education University of Hong Kong

研究负责人通讯地址:

The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

Applicant address:

10 Lo Ping Road, Tai Po, New Territories, Hong Kong, The Education University of Hong Kong

Study leader's address:

The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

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:

Department of Health and Physical Education, The Education University of Hong Kong.

Applicant's institution:

Department of Health and Physical Education, The Education University of Hong Kong.

研究负责人所在单位:

Department of Health and Physical Education, The Education University of Hong Kong.

Affiliation of the Leader:

Department of Health and Physical Education, The Education University of Hong Kong.

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:

2020-2021-0278

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:

Human Research Ethics Committee of the Education University of Hong Kong

Name of the ethic committee:

Human Research Ethics Committee of the Education University of Hong Kong

伦理委员会批准日期:

Date of approved by ethic committee:

2021-03-26 00:00:00

伦理委员会联系人:

Chung Patsy

Contact Name of the ethic committee:

Chung Patsy

伦理委员会联系地址:

The Education University of Hong Kong. 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

Contact Address of the ethic committee:

The Education University of Hong Kong. 10 Lo Ping Road, Tai Po, New Territories, Hong Kong

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:

The Education University of Hong Kong

Primary sponsor:

The Education University of Hong Kong

研究实施负责(组长)单位地址:

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

Primary sponsor's address:

10 Lo Ping Road, Tai Po, New Territories, Hong Kong

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

Nil

省(直辖市):

Nil

市(区县):

Country:

Nil

Province:

Nil

City:

单位(医院):

Nil

具体地址:

Nil

Institution
hospital:

Nil

Address:

Nil

经费或物资来源:

A.R. Medicome Inc (Asia) Ltd

Source(s) of funding:

A.R. Medicome Inc (Asia) Ltd

研究疾病:

Viral Disease  

Target disease:

Viral Disease

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:

Investigate the effectiveness of a new school cleaning protocol in reducing the environmental contamination of influenza virus and staphylococcus aureus bacteria in kindergarten and primary school settings.  

Objectives of Study:

Investigate the effectiveness of a new school cleaning protocol in reducing the environmental contamination of influenza virus and staphylococcus aureus bacteria in kindergarten and primary school settings.

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:

Schools had no cleaning team.

Exclusion criteria:

Schools had no cleaning team.

研究实施时间:

Study execute time:

From 2021-04-01 00:00:00 To 2022-03-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2021-04-01 00:00:00 To 2021-06-01 00:00:00

干预措施:

Interventions:

组别:

Intervention

样本量:

20

Group:

Intervention

Sample size:

干预措施:

disposable wipe

干预措施代码:

A

Intervention:

disposable wipe

Intervention code:

组别:

Intervention

样本量:

20

Group:

Intervention

Sample size:

干预措施:

no wipe

干预措施代码:

B

Intervention:

no wipe

Intervention code:

组别:

Control

样本量:

20

Group:

Control

Sample size:

干预措施:

no intervention

干预措施代码:

C

Intervention:

no intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

China

省(直辖市):

Hong Kong SAR 

市(区县):

Hong Kong 

Country:

China

Province:

Hong Kong SAR

City:

Hong Kong

单位(医院):

Schools 

单位级别:

 

Institution
hospital:

Schools

Level of the institution:

测量指标:

Outcomes:

指标中文名:

Bacterial count

指标类型:

主要指标

Outcome:

Bacterial count

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:

标本中文名:

Environmental sampling

组织:

Sample Name:

Environmental sampling

Tissue:

人体标本去向

使用后销毁  

说明

Fate of sample:

Destruction after use  

Note:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 31 years
最大 Max age 56 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):

Randomization was implemented by putting the sealed codes of schools for selection inside a paper bag. The random number sequence based on a table of random numbers, which is generated by computer. The schools were then drawn randomly by an individual who was not associated with the study for allocation

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

Randomization was implemented by putting the sealed codes of schools for selection inside a paper bag. The random number sequence based on a table of random numbers, which is generated by computer. The schools were then drawn randomly by an individual who was not associated with the study for allocation

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:

Not stated

Blinding:

Not stated

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):

ResMan, http://www.medresman.org.cn

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

ResMan, http://www.medresman.org.cn

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:

A standard data collection and management system will be included

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

A standard data collection and management system will be included

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:

 2022-11-29 11:26:37