ChiCTR2100046342 版本V1.2 版本创建时间2021/12/20 23:29:37 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：

 ChiCTR2100046342 

最近更新日期：

Date of Last Refreshed on：

 2021-06-08 22:27:37 

注册时间：

Date of Registration：

 2021-05-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A diabetes self-management programme for people with type 2 diabetes receiving insulin injection

Public title：

A diabetes self-management programme for people with type 2 diabetes receiving insulin injection

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of a diabetes self-management programme on self-efficacy, self-management behaviours, glycaemic control and diabetes-related distress in people with type 2 diabetes receiving insulin injection: A randomised controlled trial

Scientific title：

Effectiveness of a diabetes self-management programme on self-efficacy, self-management behaviours, glycaemic control and diabetes-related distress in people with type 2 diabetes receiving insulin injection: A randomised controlled trial

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：

梁玮 

研究负责人：

梁玮 

Applicant：

LIANG Wei 

Study leader：

LIANG Wei 

申请注册联系人电话：

Applicant telephone：

 +852 52273500

研究负责人电话：

Study leader's
telephone：

+852 52273500

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：

 lovenursing@126.com

研究负责人电子邮件：

Study leader's E-mail：

 lovenursing@126.com

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香港中文大學利黃瑤璧樓6樓

研究负责人通讯地址：

中國香港特別行政區新界沙田香港中文大學利黃瑤璧樓6樓

Applicant address：

6/F Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, China

Study leader's address：

6/F Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, 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

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

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：

 2021.172-T

伦理委员会批件附件：

Approved file of Ethical Committee：

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：

 2021-04-29 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：

中國香港特別行政區新界沙田銀城街威爾士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, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

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香港中文大學利黃瑤璧樓R829

Primary sponsor's address：

Room 829, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong, 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

Community Health Service Centre of Fengpu Street

具体地址：

Institution
hospital：

Community Health Service Centre of Fengpu Street

Address：

经费或物资来源：

Self- financing

Source(s) of funding：

Self- financing

研究疾病：

糖尿病  

Target disease：

Diabetes

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：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The study aims to examine the effects of a culturally adapted diabetes self-management programme (DSMP) in promoting self-efficacy, improving self-management behaviours, reducing HbA1c and diabetes-related distress in Chinese people with T2D receiving insulin injection.  

Objectives of Study：

The study aims to examine the effects of a culturally adapted diabetes self-management programme (DSMP) in promoting self-efficacy, improving self-management behaviours, reducing HbA1c and diabetes-related distress in Chinese people with T2D receiving insulin injection.

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) Chinese people aged 18 years old or above;
2) a medical diagnosis of T2D for at least six months to allow for the development of self-care skills and initial psychological adjustment;
3) receiving insulin injection with or without oral antihyperglycemic agents;
4) a HbA1c test >7.0% within three months of recruitment indicating poor glycaemic control;
5) residing in the communities in Shanghai;
6) available for telephone follow-up;
7) consent to participate in the study;
8) able to communicate in Putonghua and read simplified Chinese.

Inclusion criteria

1) Chinese people aged 18 years old or above;
2) a medical diagnosis of T2D for at least six months to allow for the development of self-care skills and initial psychological adjustment;
3) receiving insulin injection with or without oral antihyperglycemic agents;
4) a HbA1c test >7.0% within three months of recruitment indicating poor glycaemic control;
5) residing in the communities in Shanghai;
6) available for telephone follow-up;
7) consent to participate in the study;
8) able to communicate in Putonghua and read simplified Chinese.

排除标准：

Participants will be excluded if they have participated in diabetes education programmes within the last six months; cognitive impairment or a major psychiatric disorder (i.e. schizophrenia, bipolar disorder) and currently receiving treatment as indicated by the medical record; severe complications of chronic diseases (i.e. advanced macro-micro vascular complication); severe medical or health conditions (i.e. being bedridden, end-stage renal disease on dialysis, heart failure); terminal illness such as advanced cancer; or aural and/or visual impairment.

Exclusion criteria：

Participants will be excluded if they have participated in diabetes education programmes within the last six months; cognitive impairment or a major psychiatric disorder (i.e. schizophrenia, bipolar disorder) and currently receiving treatment as indicated by the medical record; severe complications of chronic diseases (i.e. advanced macro-micro vascular complication); severe medical or health conditions (i.e. being bedridden, end-stage renal disease on dialysis, heart failure); terminal illness such as advanced cancer; or aural and/or visual impairment.

研究实施时间：

Study execute time：

从 From 2021-06-06 00:00:00至 To 2022-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-06-07 00:00:00 至 To 2021-10-15 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 92

Group：

Intervention group

Sample size：

干预措施：

A diabetes self-management programme

干预措施代码：

Intervention：

A diabetes self-management programme

Intervention code：

组别：

Control group

样本量：

 92

Group：

Control group

Sample size：

干预措施：

Attentional control

干预措施代码：

Intervention：

Attentional control

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 Community Health Service Centre of Fengpu Street 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Community Health Service Centre of Fengpu Street

Level of the institution：

C

测量指标：

Outcomes：

指标中文名：

Self-efficacy

指标类型：

主要指标

Outcome：

Self-efficacy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Self-management behaviours

指标类型：

次要指标

Outcome：

Self-management behaviours

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

HbA1c

指标类型：

次要指标

Outcome：

HbA1c

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Diabetes-related distress

指标类型：

次要指标

Outcome：

Diabetes-related distress

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Qualitative interview

指标类型：

附加指标

Outcome：

Qualitative interview

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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 18 岁 years
最大 Max age 85 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）：

block randomization (generated using a computer programme by a research assistant).

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

block randomization (generated using a computer programme by a research assistant).

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：

The outcome assessor will be blinded to the group allocation until all data collection was completed

Blinding：

The outcome assessor will be blinded to the group allocation until all data collection was completed

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）：

http://www.chictr.org.cn/index.aspx

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

http://www.chictr.org.cn/index.aspx

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：

Research data will be collected by trained research assistants. The quantitative data will be entered using EpiData software and managed by SPSS software. The qualitative data will be managed by NVivo 12.0.

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

Research data will be collected by trained research assistants. The quantitative data will be entered using EpiData software and managed by SPSS software. The qualitative data will be managed by NVivo 12.0.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-05-14 05:43:15