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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
151
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.
Regular patient education on insulin injection at the control arm hospital.
Lee's clinic
Kaohsiung City, Taiwan
Change in Glycosylated Hemoglobin (HbA1c) Levels
Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels
Time frame: At baseline and 12 months after the intervention
Change in Diabetes Empowerment Process
A 13-item Chinese version of the Diabetes Empowerment Process Scale was used to assess the perceived level of empowerment by healthcare providers in participants. Each item was rated on a 5-point scale with scores ranging from 0 (strongly disagree) to 4 (strongly agree). The total score range from 13 to 65. A higher score indicated higher perceived patient empowerment.
Time frame: At baseline and 12 months after the intervention
Change in Diabetes Distress
An 8-item Chinese version of the short-form Problem Areas in Diabetes Scale was used to assess the levels of diabetes distress in participants. The response of each item was rated from 0 (not a problem) to 4 (serious problem). The total score ranged from 8 to 32. A higher score represented severer diabetes distress.
Time frame: At baseline and 12 months after the intervention
Change in Quality of Life
A 15-item Diabetes-Specific Quality-of-Life Scale was used to assess the subjective appraisal of participants in their perceived degree to which their current health-related aspects in life were affected by emotional suffering, social functioning, adherence to treatment regimen, and diabetic-specific symptoms. Each item was rated from "very much" (0 point) to "not at all" (4 points). The total score ranged from 0 to 60. A higher score indicated better quality of life.
Time frame: At baseline and 12 months after the intervention
Change in Body Mass Index
Physiological parameter which will be collected from body weight scale and height scale, and will be converted to body mass index (weight (kg)/ height(m) 2
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Time frame: At baseline and 12 months after the intervention