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Self-management Behaviours and Disease Control of Type 2 Diabetes Mellitus Patients Among Working Population in Hong Kong
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注册号：

Registration number：

 ChiCTR1900028083 

最近更新日期：

Date of Last Refreshed on：

 2019-12-11 

注册时间：

Date of Registration：

2019-12-11 

注册号状态：

预注册  

Registration Status：

Prospective registration  

注册题目：

Self-management Behaviours and Disease Control of Type 2 Diabetes Mellitus Patients Among Working Population in Hong Kong 

Public title：

Self-management Behaviours and Disease Control of Type 2 Diabetes Mellitus Patients Among Working Population in Hong Kong 

注册题目简写：

 

English Acronym：

 

研究课题的正式科学名称：

Self-management Behaviours and Disease Control of Type 2 Diabetes Mellitus Patients Among Working Population in Hong Kong 

Scientific title：

Self-management Behaviours and Disease Control of Type 2 Diabetes Mellitus Patients Among Working Population in Hong Kong 

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：

Heidi Hung 

研究负责人：

Heidi Hung 

Applicant：

Heidi Hung 

Study leader：

Heidi Hung 

申请注册联系人电话：

Applicant telephone：

+852 9098 2216 

研究负责人电话：

Study leader's telephone：

+852 9098 2216 

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：

heidihung@link.cuhk.edu.hk 

研究负责人电子邮件：

Study leader's E-mail：

heidihung@link.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：

中國香港特別行政區新界沙田威爾士親王醫院公共衛生與基層醫療學院4樓503室 

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院公共衛生與基層醫療學院4樓503室 

Applicant address：

Room 503, The School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China 

Study leader's address：

Room 503, The School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories, 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：

香港中文大學 

Applicant's institution：

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：

2019.487 

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：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC)  

伦理委员会批准日期：

Date of approved by ethic committee：

2019-10-08 

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：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F 

Contact Address of the ethic committee：

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

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：

crec@cuhk.edu.hk 

研究实施负责（组长）单位：

香港中文大學 

Primary sponsor：

The Chinese University of Hong Kong 

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田威爾士親王醫院公共衛生與基層醫療學院 

Primary sponsor's address：

The School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, New Territories, Hong Kong, China 

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Study grant of study lead  

Source(s) of funding：

Study grant of study lead  

研究疾病：

糖尿病 

Target disease：

Diabetes 

研究疾病代码：

 

Target disease code：

 

研究类型：

观察性研究 

Study type：

Observational study 

研究所处阶段：

其它 

Study phase：

N/A 

研究目的：

The overall aim of this proposed study is to investigate if and how employment affects the self-management and disease control by the type 2 DM patients among the working population. The study objectives are: (1) To investigate if there is any difference in the self-management behaviours and disease control between type 2 DM patients with and without employment; (2) To investigate if there are occupational differences in the self-management and disease control among type 2 DM patients with employment; (3) To investigate if certain working conditions are associated with self-management behaviours and disease control of type 2 DM patients with employment; and (4) To investigate if self-management behaviours mediate the association between working condition and disease control for type 2 DM patients with employment. 

Objectives of Study：

The overall aim of this proposed study is to investigate if and how employment affects the self-management and disease control by the type 2 DM patients among the working population. The study objectives are: (1) To investigate if there is any difference in the self-management behaviours and disease control between type 2 DM patients with and without employment; (2) To investigate if there are occupational differences in the self-management and disease control among type 2 DM patients with employment; (3) To investigate if certain working conditions are associated with self-management behaviours and disease control of type 2 DM patients with employment; and (4) To investigate if self-management behaviours mediate the association between working condition and disease control for type 2 DM patients with employment. 

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

No treatment involved.  

研究设计：

连续入组 

Study design：

Sequential 

纳入标准：

(1) Holder of Hong Kong Identity Cards; (2) Able to understand Cantonese; (3) Aged between 18 and 65; and (4) Diagnosed with type 2 DM for at least 6 months.  

Inclusion criteria

(1) Holder of Hong Kong Identity Cards; (2) Able to understand Cantonese; (3) Aged between 18 and 65; and (4) Diagnosed with type 2 DM for at least 6 months.  

排除标准：

(1) Refuse to give informed consent; and (2) Foreign domestic helpers. 

Exclusion criteria：

(1) Refuse to give informed consent; and (2) Foreign domestic helpers. 

研究实施时间：

Study execute time：

从From2020-01-02至To  

征募观察对象时间：

Recruiting time：

从From2020-01-02至To 2020-12-31 

干预措施：

Interventions：

组别：

Case series

样本量：

 750

Group：

Case series

Sample size：

干预措施：

No intervention

干预措施代码：

Intervention：

No intervention

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 SAR 

City：

  

单位(医院)：

 威爾士親王醫院 

单位级别：

 三级医院 

Institution
hospital：

 Prince of Wales Hospital  

Level of the institution：

 Tertiary 

国家：

 中國 

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

 China 

Province：

 Hong Kong SAR 

City：

 Hong Kong 

单位(医院)：

 粉嶺家庭醫學中心 

单位级别：

 社區衛生服務中心 

Institution
hospital：

 Fanling Family Medicine Centre  

Level of the institution：

 Community Health Service Center 

测量指标：

Outcomes：

指标中文名：

Self-management behaviours

指标类型：

主要指标 

Outcome：

Self-management behaviours

Type：

Primary indicator 

测量时间点：

At the time when completing questionnaire

测量方法：

Questionnare

Measure time point of outcome：

At the time when completing questionnaire

Measure method：

Questionnare

指标中文名：

HbA1c

指标类型：

主要指标 

Outcome：

HbA1c

Type：

Primary indicator 

测量时间点：

Patients’ latest HbA1c counts available from hospital/ clinic three months after the completion of the questionnaire

测量方法：

Clinical records

Measure time point of outcome：

Patients’ latest HbA1c counts available from hospital/ clinic three months after the completion of the questionnaire

Measure method：

Clinical records

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

No

Tissue：

No tissue involved

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 65 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）：

No

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

No. All patients attending appointments at the participating hospital and clinic who meet the inclusion criteria will be invited to participate

盲法：

No

Blinding：

No

试验完成后的统计结果（上传文件）：

Calculated Results ater
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：

Personal data will be collected only as necessary for follow-up, for adequate description of the study population, and for answering the research questions. The data collected will be used on confidential basis and for research purpose only, and the personal data of the participants will not be disclosed. To protect the participant’s confidentiality, the names of the participants will not be included in the questionnaire, and the data collected in the questionnaire and the HbA1c records will be matched with unique identifier instead of names of patients. The data collected will be accessible only by the researchers involved in the project. All hardcopies of personal data will be stored in locked file cabinet. All electronic records of personal data and discussion will be stored in password-protected computers with electronic files with password, accessible only by researchers involved in the project. All data collected will be used only for research purpose only and be destroyed within 3 years after completion of the study. Participants can request withdrawal of their personal data any time after participating in the study, and their request will be handled within 6 months.

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

Personal data will be collected only as necessary for follow-up, for adequate description of the study population, and for answering the research questions. The data collected will be used on confidential basis and for research purpose only, and the personal data of the participants will not be disclosed. To protect the participant’s confidentiality, the names of the participants will not be included in the questionnaire, and the data collected in the questionnaire and the HbA1c records will be matched with unique identifier instead of names of patients. The data collected will be accessible only by the researchers involved in the project. All hardcopies of personal data will be stored in locked file cabinet. All electronic records of personal data and discussion will be stored in password-protected computers with electronic files with password, accessible only by researchers involved in the project. All data collected will be used only for research purpose only and be destroyed within 3 years after completion of the study. Participants can request withdrawal of their personal data any time after participating in the study, and their request will be handled within 6 months.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

 2019-12-11
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