The Effectiveness of Intervention on Insulin Injection

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Behavioral: TTM Intervention for Insulin Initiation
Behavioral: Usual care

Registration Number: NCT03324451

Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	TTM Intervention for Insulin Initiation	The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management
Control arm	Usual care	The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.

Primary Outcome Measures

Name	Time	Method
Change in Glycosylated Hemoglobin (HbA1c) Levels	At baseline and 12 months after the intervention	Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels

Secondary Outcome Measures

Name	Time	Method
Change in Diabetes Empowerment Process	At baseline and 12 months after the intervention	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.
Change in Diabetes Distress	At baseline and 12 months after the intervention	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.
Change in Quality of Life	At baseline and 12 months after the intervention	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.
Change in Body Mass Index	At baseline and 12 months after the intervention	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