ChiCTR1800016095 版本V1.0 版本创建时间2019/03/31 20:23:43 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：

ChiCTR1800016095 

最近更新日期：

Date of Last Refreshed on：

2018-05-11 11:39:02 

注册时间：

Date of Registration：

2018-04-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

急症室服務經驗調查

Public title：

PES on Accident and Emergency Service

注册题目简写：

English Acronym：

研究课题的正式科学名称：

急症室服務經驗調查

Scientific title：

Development of Short-form Questionnaire for PES on Accident and Emergency Service (SF-AEEQ)

研究课题代号(代码)：

Study subject ID：

 MD13931

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：

CUHK_CCRB00602

申请注册联系人：

Ms. Annie CHEUNG 

研究负责人：

Professor Eliza Wong 

Applicant：

Ms. Annie CHEUNG 

Study leader：

Professor Eliza Wong 

申请注册联系人电话：

Applicant telephone：

+852 22528406

研究负责人电话：

Study leader's telephone：

+852 22528772

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：

anniewlcheung@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

lywong@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/536

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/536

申请注册联系人通讯地址：

Rm 415, School of Public Health Building, Prince of Wales Hospital, Sha Tin, Hong Kong, China

研究负责人通讯地址：

Rm 418, School of Public Health Building, Prince of Wales Hospital, Sha Tin, Hong Kong, China

Applicant address：

Rm 415, School of Public Health Building, Prince of Wales Hospital, Sha Tin, Hong Kong, China

Study leader's address：

Rm 418, School of Public Health Building, Prince of Wales Hospital, Sha Tin, Hong Kong, 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：

JC School of Publilc Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong

Applicant's institution：

JC School of Publilc Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong

研究负责人所在单位：

JC School of Public Health and Primary Care , Faculty of Medicine, The Chinese University of Hong Kong

Affiliation of the Leader：

JC School of Public Health and Primary Care , Faculty of Medicine, The Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2017.584

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2017-12-20 00:00:00

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：

School of Public Health Building, Prince of Wales Hospital

Primary sponsor：

School of Public Health Building, Prince of Wales Hospital

研究实施负责（组长）单位地址：

School of Public Health Building, Prince of Wales Hospital

Primary sponsor's address：

School of Public Health Building, Prince of Wales Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Hospital Authority

Source(s) of funding：

Hospital Authority

Target disease：

Medical service

Target disease code：

研究类型：

流行病学研究

Study type：

Epidemilogical research

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

急症室服務經驗調查  

Objectives of Study：

Development of Short-form Questionnaire for PES on Accident and Emergency Service (SF-AEEQ)

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. Received HA A&E service during the survey period;
2. Hong Kong citizens with the Hong Kong Identity Card;
3. Aged 18 or above on the date of attendance;
4. Able to be contacted within two weeks after attendance;
5. Able to listen and speak Cantonese.

Inclusion criteria

1. Received HA A&E service during the survey period;
2. Hong Kong citizens with the Hong Kong Identity Card;
3. Aged 18 or above on the date of attendance;
4. Able to be contacted within two weeks after attendance;
5. Able to listen and speak Cantonese.

排除标准：

1. Deceased patients;
2. Children or young persons aged under 18 years at the date of their attendance at the A&E departments;
3. Any patients who are known to be current inpatients during interview.

Exclusion criteria：

1. Deceased patients;
2. Children or young persons aged under 18 years at the date of their attendance at the A&E departments;
3. Any patients who are known to be current inpatients during interview.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2018-07-01 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

Case series

样本量：

510

Group：

Case series

Sample size：

干预措施：

No procedure/ treatment will be carried through out the studies.

干预措施代码：

Intervention：

No procedure/ treatment will be carried through out the studies.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SR 

City：

 

单位(医院)：

School of Public Health Building, Prince of Wales Hospital 

单位级别：

School of Public Health Building, Prince of Wales Hospital 

Institution
hospital：

School of Public Health Building, Prince of Wales Hospital

Level of the institution：

School of Public Health Building, Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

A validated Short-form Questionnaire (SF-AEEQ) on A&E service

指标类型：

主要指标

Outcome：

A validated Short-form Questionnaire (SF-AEEQ) on A&E service

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 岁 years
最大 Max age 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）：

N/A

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

N/A

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：

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

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：

有/Yes

注册人：

Name of Registration：

  2018-05-11 11:39:02