The Effectiveness of Intervention on Insulin Injection

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03324451
• Other study ID #: KMUHIRB-E(I)-20150262
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2020
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• TTM Intervention for Insulin Initiation
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.
• Usual care
Regular patient education on insulin injection at the control arm hospital.

Locations

Country	Name	City	State
Taiwan	Lee's clinic	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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