The Effect of Tele-Nursing Based Motivational Interviewing in Individuals With Type 2 Diabetes:RCT

Not Applicable

Completed

• Conditions: Motivational Interview; Cholesterol; Lipidosis; LDL - Low Density Lipoprotein Receptor Disorder; Type2 Diabetes; Self Efficacy; Self Management; Tele-nursing; High Density Lipoprotein Deficiency
• Interventions: Behavioral: Tele-Nursing based Motivational Interviewing

• Registration Number: NCT05628259
• Lead Sponsor: Pamukkale University

Brief Summary

This study carried out to examine the effect of tele-nursing based motivational interviewing on diabetes self-efficacy, diabetes self-management and metabolic control parameters (Body mass index, waist circumference, HbA1c%,fasting blood glucose, LDL cholesterol, HDL cholesterol, total cholesterol, triglyceride) in individuals with type 2 diabetes.

Detailed Description

The first researcher of the article who applied Motivational Interviewing Techniques has a "Motivational Interviewing Techniques Training" certificate. A motivational interview (MI) program based on the telenursing approach was prepared by the researchers based on the literature for the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.

Study Timeline

• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-25
• Study First Posted: 2022-11-28
• Study Start: 2023-02-01
• Primary Completion: 2023-05-02
• Study Completion: 2023-10-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-10
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. being over 18 years old, 2) receiving insulin or insulin + oral therapy, 3) diagnosis of type 2 diabetes at least one year ago, 4) having a BMI of 25 and above, 5) HbA1c value of 7 and above, 6) access to phone, 7) voluntarily agreeing to participate in the study.

Exclusion Criteria

1. have a physical disability.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Tele-Nursing based Motivational Interviewing	A motivational interview (MI) program based on the telenursing approach was applied to the individuals in the experimental group. In this study, the MI procedure includes eight sessions in total, with four sessions of motivational interviews by phone in the first month of the intervention and four sessions of motivational interviews by phone in the next two months for each individual. Pre-tests were collected in the first month. Afterwards, MI intervention was applied for three months. This intervention was applied to the experimental group in addition to the routine care provided by the hospital. MI application took an average of 45-60 minutes via phone call.

Primary Outcome Measures

Name	Time	Method
Diabetes Self-Management Scale	Change from Baseline diabetes self-management at 6 months	This scale was used to measure the behavioral component of individuals in the IMB model. The validity and reliability study of the Turkish Diabetes Self-Management Perception Scale was conducted by Eroğlu and Sabuncu (2018). The scale consists of 16 items and 4 sub-dimensions and is a 4-point Likert type. Glucose Management sub-dimension: Items 4, 6, 10, 12 (items 4 and 12 are about drug use, items 1, 6 and 10 are about blood glucose monitoring). Diet Control sub-dimension: Items 2, 5, 9, 13. Physical Activity sub-dimension: Items 8, 11, 15. Use of Health Services sub-dimension: It consists of 3, 7, 14, and 16 items. The DMS scale consists of 16 items, 7 of which are straight and 9 of which are reversed. The scores of the items numbered "5, 7, 10, 11, 12, 13, 14, 15 and 16" in the scale are calculated by reversing them. Diabetes self-management increases as the score gets closer to 10.
Diabetes Self-Efficacy Scale	Change from Baseline diabetes self-efficacy at 6 months	The change in diabetes self efficacy of individuals with Type 2 diabetes at 3rd month and 6 rd month with the Diabetes Self-Efficacy Scale.

Secondary Outcome Measures

Name	Time	Method
HbA1c%	Change from Baseline HbA1c% at 6 months	Hemoglobin A1C
Triglyceride	Change from Baseline total triglyceride at 6 months	triglyceride
BMI	Change from Baseline Body Mass Index at 6 months	Body Mass Index
HDL	Change from Baseline HDL at 6 months	High-density lipoprotein
waist circumference	Change from Baseline waist circumference at 6 months	waist circumference
LDL	Change from Baseline LDL at 6 months	Low-density lipoprotein
Total cholesterol	Change from Baseline total cholesterol at 6 months	Total cholesterol
FBG	Change from Baseline Fasting glucose at 6 months	Fasting blood glucose

Trial Locations

Locations (3)

Şengül AYDIN YOLDEMİR; 🇹🇷 Istanbul, Turkey

Eda Kılınç İşleyen; 🇹🇷 Pamukkale, Denizli, Turkey

İrem Nur ÖZDEMİR; 🇹🇷 Istanbul, Turkey