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A self-determination theory-based interprofessional intervention to improve diabetes management in the primary health care setting of Hong Kong
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注册号：

Registration number：

 ChiCTR2600118222 

最近更新日期：

Date of Last Refreshed on：

 2026-02-06 16:25:59 

注册时间：

Date of Registration：

 2026-02-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A self-determination theory-based interprofessional intervention to improve diabetes management in the primary health care setting of Hong Kong

Public title：

A self-determination theory-based interprofessional intervention to improve diabetes management in the primary health care setting of Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A self-determination theory-based interprofessional intervention to improve diabetes management in the primary health care setting of Hong Kong

Scientific title：

A self-determination theory-based interprofessional intervention to improve diabetes management in the primary health care setting of 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：

Terry Wong 

研究负责人：

Professor LEE Wing Yan, Vivian 

Applicant：

Terry Wong 

Study leader：

Professor 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：

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

研究负责人通讯地址：

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

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：

The Nethersole School of Nursing The Chinese University of Hong Kong

Applicant's institution：

The Nethersole School of Nursing The Chinese University of Hong Kong

研究负责人所在单位：

Centre for Learning Enhancement And Research, The Chinese University of Hong Kong

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

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024.155

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：

 2024-05-13 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 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：

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

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：

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

Institution
hospital：

The Chinese University of Hong Kong

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

经费或物资来源：

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

Source(s) of funding：

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

研究疾病：

Diabetes Mellitus  

Target disease：

Diabetes Mellitus

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：

1.Comparing with the control group (CG) receiving conventional didactic information, the IPE-SDT intervention group shows significant improvement on HbA1C levels. 2.The utilisation of public medical resources including accident & emergency room visit, clinic visit, and hospital admissions for diabetes-related matters in the IPE-SDT intervention group will be less than the CG. 3.The SDT-IPE educational intervention has positive effect on subjects’ psychological factors of perceived autonomy, competency, and relatedness that can result in changes in their motivation and engagement and lead to changes in health behaviours that could impact on their health status (both physical and psychological well-being) after they have received the 3-month educational program.  

Objectives of Study：

1.Comparing with the control group (CG) receiving conventional didactic information, the IPE-SDT intervention group shows significant improvement on HbA1C levels; 2.The utilisation of public medical resources including accident & emergency room visit, clinic visit, and hospital admissions for diabetes-related matters in the IPE-SDT intervention group will be less than the CG. 3.The SDT-IPE educational intervention has positive effect on subjects’ psychological factors of perceived autonomy, competency, and relatedness that can result in changes in their motivation and engagement and lead to changes in health behaviours that could impact on their health status (both physical and psychological well-being) after they have received the 3-month educational program.

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：

1. Patients who have dementia and/or cannot understand Cantonese; 2. Patients who have gestational diabetes; 3. Concurrently involved in another clinical trial, educational/behavioural modification intervention program

Exclusion criteria：

1. Patients who have dementia and/or cannot understand Cantonese; 2. Patients who have gestational diabetes; 3. Concurrently involved in another clinical trial, educational/behavioural modification intervention program

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2027-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-09 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

IPE-SDT intervention group

样本量：

 80

Group：

IPE-SDT intervention group

Sample size：

干预措施：

Subjects in the IPE-SDT intervention group will receive the theory-based interprofessional education program conducted by diabetes educators (clinical nurse & clinical pharmacist) supervised by principal and co-investigators in addition to the family doctors in the primary care setting. The clinical pharmacist and nurse, involved in the IPE-SDT group will receive a three-day training on understanding patients’ autonomy, competence, and relatedness before conducting the interventions in the IPE-SDT group.

干预措施代码：

Intervention：

Subjects in the IPE-SDT intervention group will receive the theory-based interprofessional education program conducted by diabetes educators (clinical nurse & clinical pharmacist) supervised by principal and co-investigators in addition to the family doctors in the primary care setting. The clinical pharmacist and nurse, involved in the IPE-SDT group will receive a three-day training on understanding patients’ autonomy, competence, and relatedness before conducting the interventions in the IPE-SDT group.

Intervention code：

组别：

Control Group

样本量：

 80

Group：

Control Group

Sample size：

干预措施：

Subjects in the CG will receive their usual care from their family doctors in the primary care setting.

干预措施代码：

Intervention：

Subjects in the CG will receive their usual care from their family doctors in the primary care setting.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong S.A.R. 

市(区县)：

  

Country：

China

Province：

Hong Kong S.A.R.

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 levels

指标类型：

主要指标

Outcome：

HbA1C levels

Type：

Primary indicator

测量时间点：

Month 0 & month 3.

测量方法：

Finger prick test

Measure time point of outcome：

Month 0 & month 3.

Measure method：

Finger prick test

指标中文名：

Health Care Climate Questionnaire

指标类型：

次要指标

Outcome：

Health Care Climate Questionnaire

Type：

Secondary indicator

测量时间点：

Month 0 and 3

测量方法：

Questionnaire

Measure time point of outcome：

Month 0 and 3

Measure method：

Questionnaire

指标中文名：

Perceived Competence for Diabetes Scale

指标类型：

次要指标

Outcome：

Perceived Competence for Diabetes Scale

Type：

Secondary indicator

测量时间点：

Month 0 and 3

测量方法：

Questionnaire

Measure time point of outcome：

Month 0 and 3

Measure method：

Questionnaire

指标中文名：

Multidimensional Scale of Perceived Social Support

指标类型：

次要指标

Outcome：

Multidimensional Scale of Perceived Social Support

Type：

Secondary indicator

测量时间点：

Month 0 and 3

测量方法：

Questionnaire

Measure time point of outcome：

Month 0 and 3

Measure method：

Questionnaire

指标中文名：

Treatment Self-regulation Questionnaire

指标类型：

次要指标

Outcome：

Treatment Self-regulation Questionnaire

Type：

Secondary indicator

测量时间点：

Month 0 and 3

测量方法：

Questionnaire

Measure time point of outcome：

Month 0 and 3

Measure method：

Questionnaire

指标中文名：

Self-Care Of Chronic Illness Inventory

指标类型：

次要指标

Outcome：

Self-Care Of Chronic Illness Inventory

Type：

Secondary indicator

测量时间点：

Month 0 and 3

测量方法：

Questionnaire

Measure time point of outcome：

Month 0 and 3

Measure method：

Questionnaire

指标中文名：

Euro Quality of Life - 5D

指标类型：

次要指标

Outcome：

Euro Quality of Life - 5D

Type：

Secondary indicator

测量时间点：

Month 0 and 3

测量方法：

Questionnaire

Measure time point of outcome：

Month 0 and 3

Measure method：

Questionnaire

指标中文名：

Health Empowerment Scale

指标类型：

次要指标

Outcome：

Health Empowerment Scale

Type：

Secondary indicator

测量时间点：

Month 0 and 3

测量方法：

Questionnaire

Measure time point of outcome：

Month 0 and 3

Measure method：

Questionnaire

指标中文名：

Health Resources Utilisation

指标类型：

次要指标

Outcome：

Health Resources Utilisation

Type：

Secondary indicator

测量时间点：

week 0, 2, 4, 6, 8, 10 and month 12

测量方法：

Questionnaire

Measure time point of outcome：

week 0, 2, 4, 6, 8, 10 and month 12

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

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 45 岁 years
最大 Max age 70 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：

N/A

Blinding：

N/A

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）：

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.

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：

The data will be saved in the SPSS software.

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：

  2026-02-03 15:35:04
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