The Effectiveness of Intervention on Insulin Injection

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03324451

Enrollment

151

Registered

2017-10-27

Start date

2018-03-01

Completion date

2020-03-01

Last updated

2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

BEHAVIORALTTM 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.

BEHAVIORALUsual care

Regular patient education on insulin injection at the control arm hospital.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Taiwan

Participant flow

Participants by arm

Arm	Count
Intervention Arm The arm that receives TTM Intervention for Insulin Initiation. The intervention contains three parts: (1) individual intervention; (2) insulin injection follow-up management 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.	97
Control Arm The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education. Usual care: Regular patient education on insulin injection at the control arm hospital.	54
Total	151

Baseline characteristics

Characteristic	Control Arm	Total	Intervention Arm
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	16 Participants	43 Participants	27 Participants
Age, Categorical Between 18 and 65 years	25 Participants	63 Participants	38 Participants
Age, Continuous	60.02 years STANDARD_DEVIATION 11.49	60.57 years STANDARD_DEVIATION 13.24	60.91 years STANDARD_DEVIATION 14.3
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Taiwan	54 Participants	151 Participants	97 Participants
Sex: Female, Male Female	23 Participants	53 Participants	30 Participants
Sex: Female, Male Male	18 Participants	53 Participants	35 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 97	0 / 54
other Total, other adverse events	0 / 97	0 / 54
serious Total, serious adverse events	0 / 97	0 / 54