洞察市场格局
解锁药品研发情报

客服电话

400-9696-311

医药数据查询

【ChiCTR2600115884】Effectiveness of acceptance-based diabetes self-management (ACT-DSM) for adults with type 2 diabetes for improving diabetes distress and glycaemic control: A randomised controlled trial

查看原文

立即下载

基本信息

登记号

ChiCTR2600115884

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2026-01-03

临床申请受理号

靶点

适应症

Type 2 diabetes

试验通俗题目

Effectiveness of acceptance-based diabetes self-management (ACT-DSM) for adults with type 2 diabetes for improving diabetes distress and glycaemic control: A randomised controlled trial

试验专业题目

Effectiveness of acceptance-based diabetes self-management (ACT-DSM) for adults with type 2 diabetes for improving diabetes distress and glycaemic control: A randomised controlled trial

申办单位信息

申请人联系人

请登录查看

申请人名称

请登录查看

联系人邮箱

请登录查看

联系人邮编

联系人通讯地址

请登录查看

临床试验信息

试验目的

The primary objective is to determine whether the ACT-DSM programme is more effective than conventional diabetes self-management education in reducing HbA1c over 3–12 months. The secondary objective is to assess its impact on diabetes distress, self-care, self-efficacy, psychological flexibility, and other health markers from 1 week to 12 months post-intervention. This is tested in a cluster randomised controlled trial involving adults with type 2 diabetes of ≤8 years duration, suboptimal glycaemic control (HbA1c ≥7%), and moderate-to-high diabetes distress.

试验分类

请登录查看

试验类型

整群随机分组

试验分期

其它

随机化

Six Hospital Authority general outpatient clinics are randomised (1:1) to ACT-DSM or control group using computer-generated random sequence by an independent statistician. The Principal Investigator (PI) and research team are not involved in generating the sequence. Allocation is concealed using sealed opaque envelopes.

盲法

Outcome assessor (RA2) is blinded to group allocation.

试验项目经费来源

Health and Medical Research Funding

试验范围

目标入组人数

108

实际入组人数

第一例入组时间

2026-01-02

试验终止时间

2026-07-31

是否属于一致性

入选标准

Hong Kong Chinese resident Aged 18–64 years Diagnosed with type 2 diabetes (T2D) for ≤8 years HbA1c >=7.0% in the past 3 months and confirmed at baseline capillary testing At least moderate diabetes distress: mean item score >2 on the Chinese Diabetes Distress Scale (CDDS-15) Able to communicate in Cantonese or Mandarin；

排除标准

Has a mental disorder such as: Major depression Psychosis Has an acute or severe medical illness Currently receiving or has recently received a psychological intervention for diabetes self-care；

研究者信息

研究负责人姓名

请登录查看

试验机构

The Chinese University of Hong Kong

研究负责人电话

请登录查看

研究负责人邮箱

请登录查看

研究负责人邮编

联系人通讯地址

请登录查看