The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients With Type 2 Diabetes: Application of the Transtheoretical Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Hemoglobin (HbA1c) Levels
研究概览
简要总结
The aim of the study is to assess the effectiveness of an intervention for insulin injection initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2 diabetes mellitus (T2DM).
详细描述
According to the Transtheoretical Model (TTM) proposed by Prochaska and Diclemente, people will experience different stages of change before the actual behavioral change takes place. Ineffectiveness of intervention to instigate behavioral change is largely due to failure to take into account the stage of change in which individuals are. The TTM suggests that decisional balance, which reflects the relative difference between pros and cons, is important for influencing the stage of change. In order to achieve behavioral change, the perceived pros of changing must be strengthened to outweigh the cons. In addition, individual must be self-convinced that the behavioral change is important for themselves. Furthermore, the process for behavioral change can be provided to facilitate behavioral change in individuals. The theory of TTM has yet been used to improve the behavior of insulin initiation in insulin-naïve patients with T2DM. Thus, this study aims to assess the effectiveness of an intervention for insulin injection initiation based on the TTM in insulin-naïve patients with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) diagnosed with T2DM for at least half a year; (2) aged 20-70 years old; (3) controlling diabetes only through oral medication, without previous experience in insulin injection; (4) HbA1c≧8.5% as measured more than twice in a year; (5) considered suitable and recommended by the doctor to initiate insulin injection.
排除标准
- •(1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.
研究组 & 干预措施
Intervention arm
The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
干预措施: TTM Intervention for Insulin Initiation (Behavioral)
Control arm
The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Change in Glycosylated Hemoglobin (HbA1c) Levels
时间窗: At baseline and 12 months after the intervention
Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels
次要结局
- Change in Diabetes Empowerment Process(At baseline and 12 months after the intervention)
- Change in Diabetes Distress(At baseline and 12 months after the intervention)
- Change in Quality of Life(At baseline and 12 months after the intervention)
- Change in Body Mass Index(At baseline and 12 months after the intervention)
研究者
Ruey-Hsia Wang, PhD
Professor
Kaohsiung Medical University Chung-Ho Memorial Hospital
