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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İrem Nur ÖZDEMİR
  • Istanbul, Turkey
    • Şengül AYDIN YOLDEMİR
  • Denizli
    • Pamukkale, Denizli, Turkey, (545)-561 96 83
      • Eda Kılınç İşleyen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 64 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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.	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.
No Intervention: Control Group; The control group received routine nursing care in the diabetes policlinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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.	Change from Baseline diabetes self-management at 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pamukkale University
• Collaborators: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Study Chair: Eda KILINÇ İŞLEYEN, PhD. RN., Uşak University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): October 2, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Dyslipidemias; Lipid Metabolism, Inborn Errors; Diabetes Mellitus; Diabetes Mellitus, Type 2; Lipidoses; Hypolipoproteinemias
• Other Study ID Numbers: EKILINCISLEYEN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No