Clinical trial NCT03324451: The Effectiveness of Intervention on Insulin Injection
Official title: The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients With Type 2 Diabetes: Application of the Transtheoretical Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 151
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c) Levels
timeFrame: At baseline and 12 months after the intervention
Secondary outcomes:
measure: Change in Diabetes Empowerment Process
timeFrame: At baseline and 12 months after the intervention
measure: Change in Diabetes Distress
timeFrame: At baseline and 12 months after the intervention
measure: Change in Quality of Life
timeFrame: At baseline and 12 months after the intervention
measure: Change in Body Mass Index
timeFrame: At baseline and 12 months after the intervention
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Lee's clinic
Study officials:
affiliation: Kaohsiung Medical University
name: Ruey-Hsia Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: