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Effect of an evidence-based assessment instrument to minimize the use of physical restraint in general adult ward settings in Hong Kong: A cluster randomized controlled trial
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注册号：

Registration number：

 ChiCTR2500099134 

最近更新日期：

Date of Last Refreshed on：

 2025-03-19 09:09:47 

注册时间：

Date of Registration：

 2025-03-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of an evidence-based assessment instrument to minimize the use of physical restraint in general adult ward settings in Hong Kong: A cluster randomized controlled trial

Public title：

Effect of an evidence-based assessment instrument to minimize the use of physical restraint in general adult ward settings in Hong Kong: A cluster randomized controlled trial

注册题目简写：

Assessment instrument to minimize the use of physical restraint

English Acronym：

Assessment instrument to minimize the use of physical restraint

研究课题的正式科学名称：

Effect of an evidence-based assessment instrument to minimize the use of physical restraint in general adult ward settings in Hong Kong: A cluster randomized controlled trial

Scientific title：

Effect of an evidence-based assessment instrument to minimize the use of physical restraint in general adult ward settings in Hong Kong: A 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：

TSANG Lap Fung 

研究负责人：

TSANG Lap Fung 

Applicant：

TSANG Lap Fung 

Study leader：

TSANG Lap Fung 

申请注册联系人电话：

Applicant telephone：

 +852 9357 4447

研究负责人电话：

Study leader's
telephone：

+852 9357 4447

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：

 tsanlf1@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 tsanlf1@ha.org.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：

Ft B, 6/F, Block L, United Christian Hospital, 130 Hip Wo Street, Kwun Tong, KLN, HK

研究负责人通讯地址：

Ft B, 6/F, Block L, United Christian Hospital, 130 Hip Wo Street, Kwun Tong, KLN, HK

Applicant address：

Ft B, 6/F, Block L, United Christian Hospital, 130 Hip Wo Street, Kwun Tong, KLN, HK

Study leader's address：

Ft B, 6/F, Block L, United Christian Hospital, 130 Hip Wo Street, Kwun Tong, KLN, HK

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：

United Christian Hospital, Hong Kong Hospital Authority

Applicant's institution：

United Christian Hospital, Hong Kong Hospital Authority

研究负责人所在单位：

United Christian Hospital, Hong Kong Hospital Authority

Affiliation of the Leader：

United Christian Hospital, Hong Kong Hospital Authority

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：

 CIRB-2024-517-3

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：

Hospital Authority Central Institutional Review Board

Name of the ethic committee：

Hospital Authority Central Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-13 00:00:00

伦理委员会联系人：

Mandy Luk

Contact Name of the ethic committee：

Mandy Luk

伦理委员会联系地址：

Central Coordinating Office/HO Q&S

Contact Address of the ethic committee：

Central Coordinating Office/HO Q&S

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2300 6431

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 mandy.luk@ha.org.hk

研究实施负责（组长）单位：

United Christian Hospital, Hong Kong Hospital Authority

Primary sponsor：

United Christian Hospital, Hong Kong Hospital Authority

研究实施负责（组长）单位地址：

130 Hip Wo Street, Kwun Tong, KLN, HK

Primary sponsor's address：

130 Hip Wo Street, Kwun Tong, KLN, HK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

United Christian Hospital, Hong Kong Hospital Authority

具体地址：

130 Hip Wo Street, Kwun Tong, KLN, HK

Institution
hospital：

United Christian Hospital, Hong Kong Hospital Authority

Address：

130 Hip Wo Street, Kwun Tong, KLN, HK

经费或物资来源：

Nil

Source(s) of funding：

Nil

研究疾病：

Nil  

Target disease：

Nil

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：

The objectives of this research are to evaluate the effect of the evidence-based assessment instrument to minimize the use of PR in general adult ward settings, and the process evaluation and satisfaction of the evidence-based assessment instrument when applying in general adult ward settings in Hong Kong.  

Objectives of Study：

The objectives of this research are to evaluate the effect of the evidence-based assessment instrument to minimize the use of PR in general adult ward settings, and the process evaluation and satisfaction of the evidence-based assessment instrument when applying in general adult ward settings in Hong Kong.

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：

For the clinical study, there are no exclusion criteria, as all patients are under treatment and care during hospitalization. Participation in the evaluation is voluntary for healthcare providers who wish to give feedback and participate in the survey.

Exclusion criteria：

For the clinical study, there are no exclusion criteria, as all patients are under treatment and care during hospitalization. Participation in the evaluation is voluntary for healthcare providers who wish to give feedback and participate in the survey.

研究实施时间：

Study execute time：

从 From 2025-03-25 00:00:00至 To 2025-06-09 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-04-08 00:00:00 至 To 2025-06-09 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 932

Group：

Intervention group

Sample size：

干预措施：

The evidence-based assessment instrument

干预措施代码：

Intervention：

The evidence-based assessment instrument

Intervention code：

组别：

Control group

样本量：

 932

Group：

Control group

Sample size：

干预措施：

Convention record form

干预措施代码：

Intervention：

Convention record form

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 United Christian Hospital 

单位级别：

 无 

Institution
hospital：

United Christian Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

Crude and absolute prevalent number per day

指标类型：

主要指标

Outcome：

Crude and absolute prevalent number per day

Type：

Primary indicator

测量时间点：

Daily

测量方法：

Data capture by responsible person

Measure time point of outcome：

Daily

Measure method：

Data capture by responsible person

指标中文名：

the duration of physical restraint use

指标类型：

次要指标

Outcome：

the duration of physical restraint use

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

safety incidents, including accidental catheter removal, falls, length of stay during hospitalization

指标类型：

次要指标

Outcome：

safety incidents, including accidental catheter removal, falls, length of stay during hospitalization

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

overall satisfaction

指标类型：

次要指标

Outcome：

overall satisfaction

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：

N/A

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 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）：

A single blinded cluster randomized controlled trial will be conducted in a total of eight wards within the department of Medicine & Geriatrics (M&G), the department of Orthopaedics & Traumatology (O&T), and the Department of Surgery (SUR) from 8th April to 9th June 2025 at UCH. Two wards from O&T and SUR, along with four wards from M&G, will be randomly assigned using simple random sampling.

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

A single blinded cluster randomized controlled trial will be conducted in a total of eight wards within the department of Medicine & Geriatrics (M&G), the department of Orthopaedics & Traumatology (O&T), and the Department of Surgery (SUR) from 8th April to 9th June 2025 at UCH. Two wards from O&T and SUR, along with four wards from M&G, will be randomly assigned using simple random sampling.

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：

A single blinded cluster randomized controlled trial will be conducted as the patient does not know which group they are allocated.

Blinding：

A single blinded cluster randomized controlled trial will be conducted as the patient does not know which group they are allocated.

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）：

Conference / publication at Journal

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

Conference / publication at Journal

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：

Data will be collected by reviewing patient medical records upon discharge throughout the study period, as well as through surveys of healthcare providers at the end of the study. Co-investigators are responsible for updating the prevalent number of restrained patients in the study sites daily.

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

Data will be collected by reviewing patient medical records upon discharge throughout the study period, as well as through surveys of healthcare providers at the end of the study. Co-investigators are responsible for updating the prevalent number of restrained patients in the study sites daily.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-03-19 09:09:23
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