The Effectiveness of Intervention on Insulin Injection

NCT03324451 | Completed Results

• 1 other identifier: KMUHIRB-E(I)-20150262
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Diabetes Empowerment Process

  At baseline and 12 months after the intervention

• Change in Diabetes Distress

  At baseline and 12 months after the intervention

• Change in Quality of Life

  At baseline and 12 months after the intervention

• Change in Body Mass Index

  At baseline and 12 months after the intervention

Study Arms (2)

Intervention arm

EXPERIMENTAL

The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management

Behavioral: TTM Intervention for Insulin Initiation

Control arm

PLACEBO COMPARATOR

The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.

Behavioral: Usual care

Interventions

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.

Intervention arm

Usual care BEHAVIORAL

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

Control arm

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Lee's clinic

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Ruey-Hsia Wang
• Organization: College of Nursing,Kaohsiung Medical University

wrhsia@kmu.edu.tw

886-3-3121101

Study Officials

• Ruey-Hsia Wang, PhD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: October 27, 2017
• Study Start: March 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)