ChiCTR2500106084 版本V1.0 版本创建时间2025/07/17 09:31:35 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：

 ChiCTR2500106084 

最近更新日期：

Date of Last Refreshed on：

 2025-07-17 09:30:14 

注册时间：

Date of Registration：

 2025-07-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Cost-effectiveness study of community care worker- professional care model in health management in sub-divided unit residence

Public title：

Cost-effectiveness study of community care worker- professional care model in health management in sub-divided unit residence

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Cost-effectiveness study of community care worker- professional care model in health management in sub-divided unit residence

Scientific title：

Cost-effectiveness study of community care worker- professional care model in health management in sub-divided unit residence

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：

Crystal Ying Chan 

研究负责人：

Eliza Lai-yi Wong 

Applicant：

Crystal Ying Chan 

Study leader：

Eliza Lai-yi Wong 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8413

研究负责人电话：

Study leader's
telephone：

+852 2252 8772

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：

 ychan@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)：

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：

Room 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

研究负责人通讯地址：

Room 418, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

Applicant address：

Room 417, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., Hong Kong

Study leader's address：

Room 418, The Jockey Club School of Public Health and Primary Care/ Faculty of Medicine Postgraduate Education Centre, Shatin, N.T., 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：

Applicant's institution：

Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

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：

 2023.023

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：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

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：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

Contact Name of the ethic committee：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

伦理委员会联系地址：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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 Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong.

Primary sponsor's address：

The Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong.

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)：

The Chinese University of Hong Kong

具体地址：

The Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong.

Institution
hospital：

The Hong Kong Jockey Club Charities Trust

Address：

The Chinese University of Hong Kong, Sha Tin, New Territories, Hong Kong.

经费或物资来源：

The Hong Kong Jockey Club Charities Trust

Source(s) of funding：

The Hong Kong Jockey Club Charities Trust

研究疾病：

Diabetes, hypertension, obesity, hyperlipidemia  

Target disease：

Diabetes, hypertension, obesity, hyperlipidemia

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：

Objectives: 1) To evaluate the cost-effectiveness of community care worker (CCW) intervention in chronic disease prevention and management (HbA1c, Blood pressure, Body weight/waist circumference) when comparing to usual care provided by dietitian intervention, and nurse intervention in real-world settings; 2) To find the next adaptive intervention when participants do not respond to the initial intervention due to individual differences.  

Objectives of Study：

Objectives: 1) To evaluate the cost-effectiveness of community care worker (CCW) intervention in chronic disease prevention and management (HbA1c, Blood pressure, Body weight/waist circumference) when comparing to usual care provided by dietitian intervention, and nurse intervention in real-world settings; 2) To find the next adaptive intervention when participants do not respond to the initial intervention due to individual differences.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Residents living in informal and transitional houses, including sub-divided flats, social houses, community care worker serving population living in informal and transitional houses, local NGO operators, project staff from CUHK AND those who can speak Chinese or English.

Inclusion criteria

Residents living in informal and transitional houses, including sub-divided flats, social houses, community care worker serving population living in informal and transitional houses, local NGO operators, project staff from CUHK AND those who can speak Chinese or English.

排除标准：

Individuals who are incapable to give consent and participants who are mentally incompetent, and those age <= 12 will be excluded.

Exclusion criteria：

Individuals who are incapable to give consent and participants who are mentally incompetent, and those age <= 12 will be excluded.

研究实施时间：

Study execute time：

从 From 2023-02-08 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-08-02 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

CCW-professional arrm

样本量：

 160

Group：

CCW-professional arrm

Sample size：

干预措施：

Beneficiaries who are randomly assigned to CCWs-professional support

干预措施代码：

 CCW

Intervention：

Beneficiaries who are randomly assigned to CCWs-professional support

Intervention code：

组别：

Dieitian arm

样本量：

 160

Group：

Dieitian arm

Sample size：

干预措施：

Beneficiaries who are randomly assigned to usual care by dietitian only

干预措施代码：

 DT

Intervention：

Beneficiaries who are randomly assigned to usual care by dietitian only

Intervention code：

组别：

Nurse arm

样本量：

 160

Group：

Nurse arm

Sample size：

干预措施：

Beneficiaries who are randomly assigned to usual care by nurse only

干预措施代码：

 RN

Intervention：

Beneficiaries who are randomly assigned to usual care by nurse only

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)：

 The Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

HbA1c

指标类型：

主要指标

Outcome：

HbA1c

Type：

Primary indicator

测量时间点：

测量方法：

POC blood test

Measure time point of outcome：

Measure method：

POC blood test

指标中文名：

Self-reported health

指标类型：

次要指标

Outcome：

Self-reported health

Type：

Secondary indicator

测量时间点：

测量方法：

Survey

Measure time point of outcome：

Measure method：

Survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

组织：

Sample Name：

Blood

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 0 岁 years
最大 Max age 80 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）：

To perform simple randomization into three groups, we used Excel’s random number generator. We started by listing each participant in a separate row and generated a random number next to each one using the formula =RAND(). After generating the random numbers, we sorted the list in ascending order. Then, we assigned participants to the three groups in sequence—Group 1, Group 2, and Group 3—as we moved down the sorted list. This approach allowed me to randomly and evenly distribute participants across all groups.

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

To perform simple randomization into three groups, we used Excel’s random number generator. We started by listing each participant in a separate row and generated a random number next to each one using the formula =RAND(). After generating the random numbers, we sorted the list in ascending order. Then, we assigned participants to the three groups in sequence—Group 1, Group 2, and Group 3—as we moved down the sorted list. This approach allowed me to randomly and evenly distribute participants across all groups.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

No blinding

Blinding：

No blinding

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）：

Upon direct communication with PI

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

Upon direct communication with PI

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：

Considering the implementation of the service, data collection will be done during the face-to-face health assessment in 0th, 3rd, 6th and 9th months. Data collection and management are safeguarded by project team and CREC.

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

Considering the implementation of the service, data collection will be done during the face-to-face health assessment in 0th, 3rd, 6th and 9th months. Data collection and management are safeguarded by project team and CREC.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-07-17 09:30:14