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

Type2 Diabetes Clinical Trial

Official title:

The Effect of Tele-Nursing Based Motivational Interviewing on Diabetes Self-Efficacy, Diabetes Self-Management and Metabolic Control Parameters in Individuals With Type 2 Diabetes: Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628259
• Other study ID #: EKILINCISLEYEN
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: October 2, 2023

Study information

• Verified date: March 2024
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholesterol; Lipidosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• High Density Lipoprotein Deficiency
• Hypolipoproteinemias
• Motivational Interview
• Self Efficacy
• Self Management
• Type2 Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Irem Nur ÖZDEMIR	Istanbul
Turkey	Sengül AYDIN YOLDEMIR	Istanbul
Turkey	Eda Kilinç Isleyen	Pamukkale	Denizli

Sponsors (2)

Lead Sponsor	Collaborator
Pamukkale University	Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Self-Efficacy Scale	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.	Change from Baseline diabetes self-efficacy at 6 months
Primary	Diabetes Self-Management Scale	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 Eroglu 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.	Change from Baseline diabetes self-management at 6 months
Secondary	HbA1c%	Hemoglobin A1C	Change from Baseline HbA1c% at 6 months
Secondary	BMI	Body Mass Index	Change from Baseline Body Mass Index at 6 months
Secondary	FBG	Fasting blood glucose	Change from Baseline Fasting glucose at 6 months
Secondary	LDL	Low-density lipoprotein	Change from Baseline LDL at 6 months
Secondary	HDL	High-density lipoprotein	Change from Baseline HDL at 6 months
Secondary	waist circumference	waist circumference	Change from Baseline waist circumference at 6 months
Secondary	Total cholesterol	Total cholesterol	Change from Baseline total cholesterol at 6 months
Secondary	Triglyceride	triglyceride	Change from Baseline total triglyceride at 6 months