ChiCTR2400082766 版本V1.0 版本创建时间2024/04/07 16:17:19 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：

 ChiCTR2400082766 

最近更新日期：

Date of Last Refreshed on：

 2024-04-07 16:17:08 

注册时间：

Date of Registration：

 2024-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Implementation of an integrated Self-Care Health Service Ecosystem

Public title：

Implementation of an integrated Self-Care Health Service Ecosystem

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Development and implementation of an integrated Self-Care Health Service Ecosystem

Scientific title：

Development and implementation of an integrated Self-Care Health Service Ecosystem

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：

Prof. Eliza Lai Yi Wong 

研究负责人：

Prof. Eliza Lai Yi Wong 

Applicant：

Prof. Eliza Lai Yi Wong 

Study leader：

Prof. Eliza Lai Yi Wong 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8772

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：

 lywong@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 418, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T. Hong Kong

研究负责人通讯地址：

Room 418, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T. Hong Kong

Applicant address：

Room 418, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T. Hong Kong

Study leader's address：

Room 418, 4/F, School of Public Health, Prince of Wales Hospital, 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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

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：

 2023.478

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：

 2023-12-18 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：

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

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 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：

Room 418, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T. Hong Kong

Primary sponsor's address：

Room 418, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T. 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：

Room 418, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T. Hong Kong

Institution
hospital：

The Chinese University of Hong Kong

Address：

Room 418, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T. Hong Kong

经费或物资来源：

Innovation and Technology Fund

Source(s) of funding：

Innovation and Technology Fund

研究疾病：

None  

Target disease：

None

研究疾病代码：

Target disease code：

研究类型：

筛查

Study type：

Screening

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：

This seed project will serve as the first phase of the development and implementation of the self-care health service ecosystem. During the first phase, we will mainly focus on the conceptualization and planning, and creation of prototype of SHE. Thus, this project aims to: 1) To identify the core features of the app and prioritize them to create the Minimum Viable Product; 2) To create wireframes and prototype to visualize the app’s layout, user flow, and interactions (prototype creation); 3) To understand users’ experience on the use of HPV self-sampling and Dried Blood Spot (DBS) in general population (experience test); 4) To validate the risk algorithms for disease prevention and health problem alert; and 5) To explore the health information that the users are in need and can be used to train the chatbot (needs exploration).  

Objectives of Study：

This seed project will serve as the first phase of the development and implementation of the self-care health service ecosystem. During the first phase, we will mainly focus on the conceptualization and planning, and creation of prototype of SHE. Thus, this project aims to: 1) To identify the core features of the app and prioritize them to create the Minimum Viable Product; 2) To create wireframes and prototype to visualize the app’s layout, user flow, and interactions (prototype creation); 3) To understand users’ experience on the use of HPV self-sampling and Dried Blood Spot (DBS) in general population (experience test); 4) To validate the risk algorithms for disease prevention and health problem alert; and 5) To explore the health information that the users are in need and can be used to train the chatbot (needs exploration).

药物成份或治疗方案详述：

This study will be a cross-sectional pilot study to test the logistic and understand the user’s experience of HPV self-sampling and DBS self-sampling kits, and health information needs among Hong Kong population. A mixed-methods will be utilized with web-based survey and in-depth interview. We will target to recruit 192 participants in this pilot. Among the 192 participants, 30 will be randomly selected to attend the in-depth interview based on the saturation principle .  

Description for medicine or protocol of treatment in detail：

This study will be a cross-sectional pilot study to test the logistic and understand the user’s experience of HPV self-sampling and DBS self-sampling kits, and health information needs among Hong Kong population. A mixed-methods will be utilized with web-based survey and in-depth interview. We will target to recruit 192 participants in this pilot. Among the 192 participants, 30 will be randomly selected to attend the in-depth interview based on the saturation principle .  

纳入标准：

1) HK resident; 2) Aged 18 or above; and 3) Able to read, understand and speaking Cantonese or English.

Inclusion criteria

1) HK resident; 2) Aged 18 or above; and 3) Able to read, understand and speaking Cantonese or English.

排除标准：

1) Current pregnancy at the time of recruitment; 2) Had total hysterectomy; 3) Have been diagnosed with an immunocompromised condition (e.g. Systemic Lupus Erythematosus, or illness with steroid-dependent); or 4) Have been diagnosed with any gynecologic cancers (e.g. cervical, ovarian, vaginal, uterine, vulvar, or breast cancer).

Exclusion criteria：

1) Current pregnancy at the time of recruitment; 2) Had total hysterectomy; 3) Have been diagnosed with an immunocompromised condition (e.g. Systemic Lupus Erythematosus, or illness with steroid-dependent); or 4) Have been diagnosed with any gynecologic cancers (e.g. cervical, ovarian, vaginal, uterine, vulvar, or breast cancer).

研究实施时间：

Study execute time：

从 From 2023-12-01 00:00:00至 To 2025-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-05-01 00:00:00 至 To 2025-05-01 00:00:00

干预措施：

Interventions：

组别：

Observation group

样本量：

 192

Group：

Observation group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

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：

  

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Self-screening

指标类型：

主要指标

Outcome：

Self-screening

Type：

Primary indicator

测量时间点：

测量方法：

HPV self-sampling

Measure time point of outcome：

Measure method：

HPV self-sampling

指标中文名：

Health monitoring

指标类型：

主要指标

Outcome：

Health monitoring

Type：

Primary indicator

测量时间点：

测量方法：

Dried Blood Spot

Measure time point of outcome：

Measure method：

Dried Blood Spot

指标中文名：

Self-awareness

指标类型：

主要指标

Outcome：

Self-awareness

Type：

Primary indicator

测量时间点：

测量方法：

chatbot for health communication

Measure time point of outcome：

Measure method：

chatbot for health communication

指标中文名：

Health risk alerts

指标类型：

主要指标

Outcome：

Health risk alerts

Type：

Primary indicator

测量时间点：

测量方法：

Risk assessments

Measure time point of outcome：

Measure method：

Risk assessments

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 120 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:

不公开/Private

盲法：

None

Blinding：

None

是否共享原始数据：

IPD sharing

否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）：

None

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

None

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：

All information of the research data will be stored securely in locked storage units which are only accessible to research staff involved in the study and will be destroyed 3 years after completion of the study.

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

All information of the research data will be stored securely in locked storage units which are only accessible to research staff involved in the study and will be destroyed 3 years after completion of the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-04-07 16:17:08