【ChiCTR2100046342】A diabetes self-management programme for people with type 2 diabetes receiving insulin injection

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基本信息

登记号

ChiCTR2100046342

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2021-05-14

临床申请受理号

靶点

适应症

糖尿病

试验通俗题目

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

试验专业题目

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

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临床试验信息

试验目的

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.

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

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

盲法

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

试验项目经费来源

Self- financing

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-06-06

试验终止时间

2022-02-28

是否属于一致性

入选标准

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.；

排除标准

1.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; 2.severe complications of chronic diseases (i.e. advanced macro-micro vascular complication); 3.severe medical or health conditions (i.e. being bedridden, end-stage renal disease on dialysis, heart failure); 4.terminal illness such as advanced cancer; or aural and/or visual impairment.；

研究者信息

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试验机构

香港中文大學

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