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

NCT05628259 | Completed

• 1 other identifier: EKILINCISLEYEN
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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.

Conditions

Type2 Diabetes; Self Efficacy; Self Management; Tele-nursing; Motivational Interview; LDL - Low Density Lipoprotein Receptor Disorder; High Density Lipoprotein Deficiency; Cholesterol; Lipidosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• HbA1c%

  Change from Baseline HbA1c% at 6 months

• BMI

  Change from Baseline Body Mass Index at 6 months

• FBG

  Change from Baseline Fasting glucose at 6 months

• LDL

  Change from Baseline LDL at 6 months

• HDL

  Change from Baseline HDL at 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The control group received routine nursing care in the diabetes policlinic.

Interventions

Tele-Nursing based Motivational Interviewing BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• \) 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.

You may not qualify if:

• \) have a physical disability.

Sponsors & Collaborators

• Pamukkale University: lead
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator

Study Sites (3)

Eda Kılınç İşleyen

Pamukkale, Denizli, (545)-561 96 83, Turkey (Türkiye)

Location

İrem Nur ÖZDEMİR

Istanbul, Turkey (Türkiye)

Location

Şengül AYDIN YOLDEMİR

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Isleyen EK, Ozdemir IN, Yoldemir SA. The effect of tele-nursing based motivational interviewing on self-efficacy, self-management and metabolic control parameters in individuals with type 2 diabetes: randomized controlled study. Ir J Med Sci. 2025 Apr;194(2):563-573. doi: 10.1007/s11845-025-03916-5. Epub 2025 Feb 21.

  PMID: 39982630 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Hypoalphalipoproteinemias; Lipidoses

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hypolipoproteinemias

Study Officials

• Eda KILINÇ İŞLEYEN, PhD. RN.

  Uşak University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding was provided that included inclusion criteria and agreement to participate in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Profesor Dr.

Model Details: This study is a parallel group randomized controlled study.

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 28, 2022
• Study Start: February 1, 2023
• Primary Completion: May 2, 2023
• Study Completion: October 2, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

TU (3)