跳至主要内容
临床试验/NCT03324451
NCT03324451已完成不适用

The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients With Type 2 Diabetes: Application of the Transtheoretical Model

Kaohsiung Medical University Chung-Ho Memorial Hospital1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

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

Experimental

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

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruey-Hsia Wang, PhD

Professor

Kaohsiung Medical University Chung-Ho Memorial Hospital

研究点 (1)

Loading locations...

相似试验