The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients With Type 2 Diabetes: Application of the Transtheoretical Model
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients 
With Type 2 Diabetes: Application of the Transtheoretical Model 
 
October 18, 2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients 
With Type 2 Diabetes: Application of the Transtheoretical Model 
Introduction 
    If not well controlled, diabetes can easily trigger various complications. 
Maintaining a glycosylated hemoglobin (HbA1c) level lower than 7% has been 
established as the standard for diabetes control. Insulin treatment has been regarded as 
an effective method, and treating diabetes with insulin early on is widely considered 
as an important principle for treating patients with type 2 diabetes mellitus (T2DM) in 
the US and Europe. However, many studies have shown that patients with T2DM are 
often reluctant to change from oral medication to insulin treatment. Research has also 
found that patients with T2DM whose glycemic control was poor delayed insulin 
treatment by 7 to 8 years. Therefore, it is necessary for healthcare professionals to 
establish a comprehensive intervention plan to help patients with poor glycemic 
control to initiate insulin injection early and adhere to the treatment. However, as far 
as is known, little research has been done on this topic in Taiwan.  
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. Subsequently, the process for behavioral change can be 
provided to facilitate behavioral change in individuals. The theory of TTM has 

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been applied to change various problematic behaviors, but so far, it 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. 
Methods 
Study design 
The present study adopts quasi-experimental design. To avoid 
contamination between participants in two study arms, cluster sampling is used. 
Patients with T2DM of an endocrinology clinic in southern Taiwan are assigned 
to the intervention arm, whereas patients at another endocrinology clinic in 
southern Taiwan are placed in the control arm. Eligible patients that match the 
inclusion criteria are recommended by doctors to initiate insulin treatment after 
getting the consent forms from eligible participants. Research assistants will 
subsequently collect baseline data from eligible participants. 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. Data for the participants in both study arms will be 
collected by research assistants at baseline, 3 months, 6 months, and 12 months 
post-intervention. The main outcome variable is change in HbA1c levels, while 
the change in stage of change, in insulin injection adherence, in appraisal of 
insulin injection, in patient empowerment, in self-efficacy for insulin injection, in 
diabetes distress, in quality of life, in triglyceride(TG), in total cholesterol (TC), 
in high-density lipoprotein cholesterol(HDL-C), in low density lipoprotein 
cholesterol(LDL-C), in urine albumin creatinine ratio (UACR), in estimated 
glomerular filtration rate(GFR) are secondary outcome variables. The outcome 

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variables and collection time points are summarized in Table 1. 
Samples 
The inclusion criteria of eligible participants are: (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 the most recent year. Exclusion 
criteria were: (1) unable to communicate with language; (2) incapable of 
self-administering insulin injection due to visual or muscular impairment. 
Eligible participants who have been assessed and considered suitable for 
changing to insulin treatment by doctor will be included in this study. 
Sample size estimation was done according to previous literature. An 
estimation of 63 participants in each study arm was calculated through setting a 
middle effect size of 0.5 between the two study arms in HbA1c levels, α of 0.05, 
and power of 0.8. Furthermore, an attrition rate of 20% was expected. Therefore, 
each study arm should include at least 76 participants. 
Measurements  
Biomedical indicator measurement 
The HbA1c levels, triglyceride(TG), total cholesterol (TC), high-density 
lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol(LDL-C), 
urine albumin creatinine ratio (UACR) will be collected through blood test. 
Estimated glomerular filtration rate(GFR) will be collected through urine test. 
Height and weight will be collected through body weight and height scales, and 
will be converted to body mass index (weight (kg)/ height(m) 2.  
Self-reported questionnaire 
The other outcome variables will be collected by self-report questionnaire. 
The questionnaire will include following contents. 

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Demographic data & disease characteristics 
Age, sex, educational level, duration of diabetes, duration of taking oral drug 
before insulin therapy will be collected at baseline. Insulin treatment regimen 
including type of insulin, dose, frequency of injection and blood sugar self-monitoring 
will be collected after participants receiving insulin injection.  
Stage of change for insulin injection. A question of stages of change for insulin 
injection was developed. At baseline, the question was “If the doctor recommends that 
you initiate insulin treatment right now, what would be your opinion?” Three 
responses to this question included “never considered”, “under consideration and 
might start within the next 6 months”, and “likely to start immediately”, which 
respectively represented three early stages of change — precontemplation, 
contemplation, and preparation. At the 3, 6, and 12 months post-intervention, the 
question was “what’s the status of your insulin injection?” The responses were 
“taking insulin injection previously, but now is stop insulin injection and never 
consider to receive insulin injection again, “taking insulin injection previously, but 
now is stop insulin injection, consider to start insulin injection again within next 6 
months”, “still receive insulin injection but sometimes forget to inject” , 
“Continuously inject insulin but less than 6 months”, “Continuously injected insulin 
and more than 6 months”. 
Insulin injection adherence. An 8-item Morisky Medication Adherence Scale was 
used to assess insulin injection adherence behaviors of participants. The total scores 
ranged from 7 to 11. The higher scores indicate, the better insulin injection adherence 
behaviors 
Appraisal of insulin injection. A 13-item Decisional Balance for Inulin Injection scale 
was used in the study to assess the appraisal of insulin injection. The scale comprised 
subscales of positive and negative appraisal. Each item was rated from 1 (strongly 

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disagree) to 5 (strongly agree). Decisional balance for insulin injection was calculated 
by deducting the mean score of positive appraisal with that of negative appraisal. The 
higher score indicated the higher decisional balance for insulin injection. 
Empowerment perception. 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.  
Self-efficacy for insulin injection. A 4-item scale was used to assess self-efficacy for 
insulin injection in participants. Each item was rated on a scale from 0 to 4 with 0 
indicating “no confidence”, 1 indicating “20-30% confidence”, 2 indicating “40-50% 
confidence”, 3 indicating “60-70% confidence”, 4 indicating “over 80% confidence”. 
A higher score represented higher confidence in performing insulin injection. 
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. 
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. 
Intervention plan of the intervention arm 
    The intervention plan contains three parts: (1) individual intervention; (2) insulin 
injection follow-up management; (3) motivational group activities. Different 

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intervention strategies are applied to patients according to their stages of change. In 
addition, a computerized information system will be applied to facilitate data 
management and recording by interveners. The strategies for individual intervention 
designed according to the stage of change and the corresponding process of change 
are shown in Table 2. Details of insulin injection follow-up management from 
preparation stage to maintenance stage are shown in Table 3. The motivational group 
activities from precontemplation stage to maintenance stage are shown in Table 4. 
Usual care of the control arm 
  Participants in the control arm attend regular patient education at the hospital. 
The contents of the education plan are as follows: 
1. Teach participants the method of injection following the standard procedure, 
including gathering insulin supplies, the steps of injection, and so on. 
2. Hand out a step-by-step pictorial guide to participants after teaching them the 
techniques and supply preparation for using insulin pen. Fill in the type and dose of 
insulin and the site and time of injection on a sheet for participants and their family to 
refer to after they return home. 
3. Recommend patients to administer blood-glucose self-monitoring and record the 
results. 
4. Conduct a telephone follow-up 3 days after patient education to check on the 
condition of insulin injection. Schedule a return visit after a week, during which the 
doctor adjusts the medication according to the results of SMBG and instructs the rule 
for dose adjustment at home. 
5. Provide a hotline for patients to seek consultation when they encounter difficulties 
or problems. 
6. Play patient education video clips on insulin injection in the waiting room when 
patients come for return visits. 

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7. Provide patient education in small groups occasionally, in which insulin-treated 
patients are invited to share their experience and clarify questions. 
Ethical consideration 
     The study is approved by the Human Experiment and Ethics Committee of two 
hospitals (NO. KMUHI-E(I)-20150262, TSGHIRB-1-105-05-163). Participants are 
informed of their rights to refuse participation in the study without any penalty. Only 
after the participants have signed the consent forms will data be collected from 
participants. 
Data Analysis 
      The statistical software program SPSS 17.0 was used for data analysis. The 
Chi-squared test and independent t-test were used to compare differences in personal 
characteristics and outcome variables between the two groups before and after 
intervention. Paired t-tests were used to examine within-group differences at baseline, 
3 months, 6 months, and 12 months post-intervention. A linear mixed-effect model 
that adjusted for the demographic data and baseline outcome variables was used to 
examine the changing amount of outcome variables from baseline to 3 months, to 6 
months, and to 12 months post-intervention between the intervention and control arms. 
Participants were considered as a random effect. First-order autoregressive was used 
in the mixed-effect model analysis with the restricted maximum likelihood (REML) 
approach. A p-value < .05 was considered statistically significant.

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Table 1. Outcome measures and collection time points 
Measures 
Baseline 
3rdmonth 
6th month 
12th month 
Demographic data & disease 
characteristics 
 
 
 
 
 
Body mass index 
 
- 
 
 
HbA1c 
 
 
 
 
Lipids (TC, HDL-C, LDL-C, 
TG) 
 
 
 
 
Renal function: UACR, GFR 
 
 
 
 
Stage of change for insulin 
injection 
 
 
 
 
Insulin injection adherence 
- 
 
 
 
Appraisal of insulin injection 
 
 
 
 
Empowerment 
 
- 
 
 
Self-efficacy 
- 

 
 
 
Diabetes distress 
 
- 
 
 
Quality of life 
 
- 
 
 

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Table 2. Individual intervention plan 
Stage of Change 
Strategy 
Process of Change 
Precontemplation 
 Use examples in which good/bad 
glycemic control has a 
positive/negative impact on 
significant others to help patients 
reflect on their own HbA1c control 
 Explain current health condition to 
patients through the changes in the 
curves of the their data 
 Use UKPDS Risk Engine to predict 
the risk of cardiovascular disease 
and cerebrovascular event in the 
future 10 to 20 years in individual 
patients 
Consciousness 
raising 
 Build a well-established trusting 
relationship 
 Use empathic skills to recognize 
the feelings of patients (fear, worry, 
guilt, etc.) 
 Guide patients to explore the 
influence of glycemic control and 
physical health on their lives 
 Explain that accepting insulin 
injection does not mean failure of 
treatment or advancement of 
disease but the natural progression 
of diabetes 
 Assess the decisional balance for 
insulin 
injection 
and 
provide 
clarification 
 Guide patients to think about 
possible benefits brought about by 
insulin injection to themselves and 
their family 
Dramatic relief 
Contemplation 
 Invite patients to compare the 
perceived pros and cons 
Self-reevaluation 

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 List all medications for treating 
diabetes and their mechanisms, 
maximum dose, expected range of 
improvement in HbA1c, possible 
side effects, and costs 
 Enhance the positive effects of 
insulin injection 
 Guide patients to consider the 
importance of good glycemic 
control 
Dramatic relief 
Preparation 
 Assess the decisional balance for 
insulin injection and provide 
guidance 
Dramatic relief 
 Set short-term targets for glycemic 
control and insulin injection with 
patients 
Self-reevaluation 
 Assess family support and provide 
patient education 
 Provide resources that give instant 
feedback and build a platform for 
instant interaction  
Helping relationship 
 Systematic 
desensitization—Gradual 
self-administered insulin injection. 
Patients first receive insulin 
injection given by healthcare 
professionals at medical 
institutions, and then slowly 
perform injection by themselves 
from withdrawing insulin, pushing 
away air bubbles, and injecting. 
Give rewards for each progress 
made 
 Instruct patients in the techniques 
for insulin injection and medicine 
preservation 
 Use the results of blood-glucose 
self-monitoring to guide patients to 
Counterconditioning 

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think about the relationship 
between insulin injection, diet, and 
physical activity  
 Provide patient education on 
blood-glucose self-monitoring and 
assessment on the ability to deal 
with hypoglycemia 
 Ask patients to continuously keep a 
daily record of the dose, time, site 
of injection, administration of 
blood-glucose self-monitoring, and 
incidents of hypo/hyperglycemia in 
the “Health Guardian Pamphlet” 
Action 
 Educate family members to 
provide support for patients 
 Build an instant online interactive 
system with professionals to 
provide feedback to patients 
Helping relationship 
 Encourage patients to adhere to the 
insulin injection plan 
 Healthcare professionals conduct 
telephone interviews and schedule 
return visits for patients on a 
regular basis 
 Instruct patients how to adjust their 
diet and exercise flexibly according 
to insulin injection so as to 
decrease the chance of termination 
caused by barriers  
 Teach patients to adjust the dose of 
insulin according to the results of 
blood-glucose self-monitoring  
Reinforcement 
management 
 Patients promise to set mid-term 
and long-term goals 
Self-liberation 
 
 
 

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Table 3. Motivational group activity 
Stage of Change 
Strategy 
Process of Change 
Precontemplation 
 Listen to fellow patients in the 
stages of action and maintenance 
share the benefits of insulin 
injection and the ways to overcome 
obstacles 
 Try out insulin injection 
 Use pictorial or multimedia 
materials to illustrate the 
relationship between insulin and 
blood-glucose 
Self-reevaluation 
Preparation 
 Listen to fellow patients in the 
stages of action and maintenance 
share the benefits of insulin 
injection and the ways to overcome 
obstacles 
 Try out insulin injection 
 Use pictorial or multimedia 
materials to illustrate the 
relationship between insulin and 
blood-glucose  
Self-reevaluation 
Action 
 Share experience in insulin 
injection and provide support and 
solution 
 Build mutually supportive 
partnerships with fellow patients 
Reinforcement 
management 
Maintenance 
 Share successful experience with 
other patients to enhance the 
motivation of the patient to 
continue insulin injection 
Reinforcement 
management 

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Table 4. Insulin injection follow-up management 
Stage of Change 
Strategy 
Process of Change 
Preparation 
 Follow up problems with insulin 
injection, e.g. dose, site of 
injection, and technique 
Reinforcement 
management 
Action 
 Guide patients to examine the 
relationship between insulin 
injection and changes in 
blood-glucose to strengthen their 
self-efficacy 
Self-reevaluation 
 Ask patients to continuously keep 
a daily record of the dose, time, 
site of injection, administration of 
blood-glucose self-monitoring, and 
incidents of hypo/hyperglycemia 
in the “Health Guardian Pamphlet” 
Counterconditioning 
Maintenance 
 Encourage patients regularly when 
HbA1c level decreases 
 Provide care and support 
Reinforcement 
management 
 
 

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Refuse 
Figure 1. Intervention flowchart of the intervention arm 
 Individual intervention 
 Motivational group 
activity (as participants) 
Recruited participants 
Baseline assessment 
Action 
stage 
Management without 
special intervention 
Accept 
HbA1c≧8.5% 
HbA1c < 8.5% 
* Motivational group activities are held once every two months. Patients in the stages of action and 
maintenance will be invited to share their experiences during the activity. 
Measurement at 
6 months 
post-intervention 
Measurement at 
3, 6, 12 months 
post-intervention 
Measurement at 
3 months post-intervention 
Measurement at 
12 months 
post-intervention 
 Individual intervention 
 Insulin injection 
follow-up management 
 Motivational group 
activity 
Precontemplation & 
Contemplation stages 
Preparation stage 
Maintenance 
stage 
HbA1c≧8.5%
HbA1c≧8.5%
HbA1c<8.5%
HbA1c≧8.5%
HbA1c<8.5% 
HbA1c < 8%