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NCT Number: NCT03324451

The Effectiveness of Intervention on Insulin Injection

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).

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lee's clinic

Kaohsiung City, 807, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TTM Intervention for Insulin Initiation

Behavioral

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

Behavioral

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

Primary outcomes

  1. Change in Glycosylated Hemoglobin (HbA1c) Levels

    Time frame: At baseline and 12 months after the intervention

    Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels

Secondary outcomes

  1. Change in Diabetes Empowerment Process

    Time frame: 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.

  2. Change in Diabetes Distress

    Time frame: 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.

  3. Change in Quality of Life

    Time frame: 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.

  4. Change in Body Mass Index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 27, 2017
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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