ChiCTR2100046342招募中4 期
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
Self- financing1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2021年6月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Self-efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The outcome assessor will be blinded to the group allocation until all data collection was completed
入排标准
- 年龄范围
- 18 至 85（—）
- 性别
- All
入选标准
- •Chinese people aged 18 years old or above;
- •a medical diagnosis of T2D for at least six months to allow for the development of self-care skills and initial psychological adjustment;
- •receiving insulin injection with or without oral antihyperglycemic agents;
- •a HbA1c test >7.0% within three months of recruitment indicating poor glycaemic control;
- •residing in the communities in Shanghai;
- •available for telephone follow-up;
- •consent to participate in the study;
- •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.
研究组 & 干预措施
Intervention group
A diabetes self-management programme
Control group
Attentional control
结局指标
主要结局
Self-efficacy
次要结局
- Self-management behaviours
- HbA1c
- Diabetes-related distress
- Qualitative interview
研究者
研究点 (1)
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