The Effectiveness of Intervention on Insulin Injection

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: TTM Intervention for Insulin Initiation
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with T2DM at a clinic in southern Taiwan are assigned to the intervention arm, whereas patients with T2DM at the endocrinology department of a hospital in northern Taiwan are placed in the control arm. Eligible patients that match the inclusion criteria are recommended by doctors to initiate insulin treatment. Research assistants will explain the objectives of this study to eligible participants. Subsequently, baseline data will be collected from participants by research assistants after the participants sign the consent forms. Afterwards, the participants in the intervention arm will receive the intervention. For the control arm, the participants will receive regular patient education originally administered at the hospital.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>The arm that receives TTM Intervention for Insulin Initiation. The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management | Behavioral: TTM Intervention for Insulin Initiation<br>* 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.<br>|
| Placebo Comparator: Control arm<br>The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education. | Behavioral: Usual care<br>* Regular patient education on insulin injection at the control arm hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Hemoglobin (HbA1c) Levels | Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels | At baseline and 12 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | At baseline and 12 months after the intervention |