ChiCTR2600120714 版本V1.0 版本创建时间2026/03/18 16:17:34 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：

ChiCTR2600120714 

最近更新日期：

Date of Last Refreshed on：

2026-03-18 16:17:25 

注册时间：

Date of Registration：

2026-03-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

以理論為基礎的跨專業教育計劃，以提高香港華人社區長者的新冠疫苗接種率

Public title：

A theory-based interprofessional educational program to improve COVID vaccination rate among Hong Kong Chinese community-dwelling elders

注册题目简写：

English Acronym：

研究课题的正式科学名称：

以理論為基礎的跨專業教育計劃，以提高香港華人社區長者的新冠疫苗接種率

Scientific title：

A theory-based interprofessional educational program to improve COVID vaccination rate among Hong Kong Chinese community-dwelling elders

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：

黃錦城 

研究负责人：

李詠恩 

Applicant：

Terry Wong 

Study leader：

LEE Wing Yan, Vivian 

申请注册联系人电话：

Applicant telephone：

+852 3943 1579

研究负责人电话：

Study leader's telephone：

+852 3943 8012

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：

terrykswong@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

vivianlee@cuhk.edu.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：

中國香港新界沙田區,香港中文大學,利黃瑤璧樓8樓808室

研究负责人通讯地址：

中國香港新界沙田區,香港中文大學,學能提升研究中心,許讓成樓5樓502室

Applicant address：

Rm 808, 8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong SAR, China

Study leader's address：

Room 502, Hui Yeung Shing Building, Centre for Learning Enhancement And Research, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, 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：

香港中文大學 那打素護理學院

Applicant's institution：

The Nethersole School of Nursing The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學 學能提升研究中心

Affiliation of the Leader：

Centre for Learning Enhancement And Research, 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：

CREC Ref. No.: 2023.044

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：

香港中文大學– 新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong KHK-NTEC CREC

伦理委员会批准日期：

Date of approved by ethic committee：

2023-02-14 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

香港沙田威爾斯親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3505 3824

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：

香港中文大學

Primary sponsor：

General Research Fund (GRF), University Grants Committee, Hong Kong

研究实施负责（组长）单位地址：

中國香港新界沙田區,香港中文大學,學能提升研究中心,許讓成樓5樓502室

Primary sponsor's address：

Room 502, Hui Yeung Shing Building, Centre for Learning Enhancement And Research, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港中文大學

具体地址：

中國香港新界沙田區香港中文大學學能提升研究中心許讓成樓5樓502室

Institution
hospital：

The Chinese University of Hong Kong

Address：

R502 Hui Yeung Shing Building Centre for Learning Enhancement And Research The Chinese University of Hong Kong Shatin N.T. Hong Kong SAR Chi

经费或物资来源：

香港大學資助委員會，優配研究金

Source(s) of funding：

General Research Fund (GRF), University Grants Committee, Hong Kong

Target disease：

COVID-19

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：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

The aim of this RCT is to examine the effects and mechanisms of a theory-based educational program on vaccination rate among community dwelling elders aged over 60 years old.  

Objectives of Study：

The aim of this RCT is to examine the effects and mechanisms of a theory-based educational program on vaccination rate among community dwelling elders aged over 60 years old.

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. All male or female Chinese community dwelling elders aged of 60 years old or older. 2. Elders who have not completed 3 doses of COVID-19 vaccines. 3. Able to give informed consent.

Inclusion criteria

1. All male or female Chinese community dwelling elders aged of 60 years old or older. 2. Elders who have not completed 3 doses of COVID-19 vaccines. 3. Able to give informed consent.

排除标准：

1. Patients who have dementia and/or cannot understand Cantonese. 2. Elders who are currently in nursing home. 3. Concurrently involved in another clinical trial, educational intervention program

Exclusion criteria：

1. Patients who have dementia and/or cannot understand Cantonese. 2. Elders who are currently in nursing home. 3. Concurrently involved in another clinical trial, educational intervention program

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-08-07 00:00:00 至 To 2025-04-16 00:00:00  

干预措施：

Interventions：

组别：

IPE-HBM Intervention Group

样本量：

75

Group：

IPE-HBM Intervention Group

Sample size：

干预措施：

Subjects in the IPE-HBM intervention group will receive the theory-based interprofessional education program conducted by a clinical nurse and a clinical pharmacist supervised by principal and coinvestigators. The educational intervention aims to empower subjects with the knowledge related to COVID-19 infection and vaccines. In addition, we also educate subjects on the daily skills on how to prevent COVID-19 infection and side effects related to COVID-19 vaccines and eventually to change their behaviours to tackle COVID-19 infection and improve vaccination rates. The IPE-HBM interventions are interactive during the 3-month program. It comprises of one individual introduction session of the website/pamphlets (45 minutes), three 45 minutes group meetings and five individual telephone contacts (20 minutes each).

干预措施代码：

Intervention：

Subjects in the IPE-HBM intervention group will receive the theory-based interprofessional education program conducted by a clinical nurse and a clinical pharmacist supervised by principal and coinvestigators. The educational intervention aims to empower subjects with the knowledge related to COVID-19 infection and vaccines. In addition, we also educate subjects on the daily skills on how to prevent COVID-19 infection and side effects related to COVID-19 vaccines and eventually to change their behaviours to tackle COVID-19 infection and improve vaccination rates. The IPE-HBM interventions are interactive during the 3-month program. It comprises of one individual introduction session of the website/pamphlets (45 minutes), three 45 minutes group meetings and five individual telephone contacts (20 minutes each).

Intervention code：

组别：

Control Group

样本量：

75

Group：

Control Group

Sample size：

干预措施：

Subjects in the CG will receive COVID-19 related information from the established government website (https://www.coronavirus.gov.hk/eng/index.html) that also includes the Centre for Health Protection website https://www.chp.gov.hk/en/features/102745.html). If subjects do not have access to internet, we shall download and print the pamphlets from the Centre for Health Protection website (https://www.chp.gov.hk/en/features/102745.html) to the elders. One 30-minute didactic lecture will be conducted to introduce the website/pamphlets for subjects in CG. A health knowledge assessment on COVID-19 infection and vaccines will be used to evaluate the change of knowledge before and after the introduction session.

干预措施代码：

Intervention：

Subjects in the CG will receive COVID-19 related information from the established government website (https://www.coronavirus.gov.hk/eng/index.html) that also includes the Centre for Health Protection website https://www.chp.gov.hk/en/features/102745.html). If subjects do not have access to internet, we shall download and print the pamphlets from the Centre for Health Protection website (https://www.chp.gov.hk/en/features/102745.html) to the elders. One 30-minute didactic lecture will be conducted to introduce the website/pamphlets for subjects in CG. A health knowledge assessment on COVID-19 infection and vaccines will be used to evaluate the change of knowledge before and after the introduction session.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港 

市(区县)：

  

Country：

China 

Province：

Hong Kong S.A.R. 

City：

 

单位(医院)：

香港中文大學 

单位级别：

大學 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

疫苗接種率

指标类型：

主要指标

Outcome：

Vaccination rate

Type：

Primary indicator

测量时间点：

Month 0 & month 12.

测量方法：

問卷

Measure time point of outcome：

Month 0 & month 12.

Measure method：

Questionnaire

指标中文名：

健康知識

指标类型：

次要指标

Outcome：

Knowledge reinforcement and enhancement

Type：

Secondary indicator

测量时间点：

Month 0 & month 3.

测量方法：

問卷

Measure time point of outcome：

Month 0 & month 3.

Measure method：

Questionnaire

指标中文名：

生活素質

指标类型：

次要指标

Outcome：

Patient empowerment and quality of life

Type：

Secondary indicator

测量时间点：

Month 0 & month 3.

测量方法：

問卷

Measure time point of outcome：

Month 0 & month 3.

Measure method：

Questionnaire

指标中文名：

健康賦權

指标类型：

次要指标

Outcome：

The Elderly Health Empowerment Scale

Type：

Secondary indicator

测量时间点：

Month 0 & month 3.

测量方法：

問卷

Measure time point of outcome：

Month 0 & month 3.

Measure method：

Questionnaire

指标中文名：

醫療資源使用

指标类型：

次要指标

Outcome：

Health resources utilisation

Type：

Secondary indicator

测量时间点：

Month 0, weeks 2, 4, 6, 8, 10 and month12.

测量方法：

問卷

Measure time point of outcome：

Month 0, weeks 2, 4, 6, 8, 10 and month12.

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 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）：

The current study adopted the RCT study design. Eligible students will be randomly assigned (1:1) with a computer-generated list of random numbers to one of the two groups.

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

The current study adopted the RCT study design. Eligible students will be randomly assigned (1:1) with a computer-generated list of random numbers to one of the two groups.

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

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）：

研究者擁有研究中的所有資料，並對資料的完整性和資料分析的準確性負責。 獲得研究者同意後可通過電子郵件索取數據。

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

Investigator has full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The data can be obtained via email with the investigator’s consent.

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：

數據將以SPSS儲存。

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

The data will be saved in the SPSS software.

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：

  2026-03-18 16:17:25