The Effectiveness of Intervention on Insulin Injection

Kaohsiung Medical University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: TTM Intervention for Insulin Initiation; Behavioral: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT03324451

KMUHIRB-E(I)-20150262

Details and patient eligibility

About

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).

Full 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.

Enrollment: 151 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

(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.

Exclusion criteria

(1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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151 participants in 2 patient groups, including a placebo group

Intervention arm

Experimental group

Description:

The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management

Treatment:

Behavioral: TTM Intervention for Insulin Initiation

Control arm

Placebo Comparator group

Description:

The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.

Treatment:

Behavioral: Usual care