NCT03324451

The Effectiveness of Intervention on Insulin Injection

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	TTM Intervention for Insulin Initiation	The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
BEHAVIORAL	Usual care	Regular patient education on insulin injection at the control arm hospital.

Timeline

• Start date: 2018-03-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2017-10-27
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

1 site across 1 country: Taiwan