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NCT Number: NCT05628259

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

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.

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Key information

Conditions

Type2 Diabetes Cholesterol; Lipidosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn High Density Lipoprotein Deficiency Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Hypoalphalipoproteinemias Hypolipoproteinemias LDL - Low Density Lipoprotein Receptor Disorder Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Metabolic Diseases Metabolism, Inborn Errors Motivational Interview Nutritional and Metabolic Diseases Self Efficacy Self Management Tele-nursing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eda Kılınç İşleyen, Pamukkale, Denizli, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • have a physical disability.

Treatment and study plan

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.

Primary outcomes

  1. Diabetes Self-Efficacy Scale

    Time frame: 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.

  2. Diabetes Self-Management Scale

    Time frame: 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.

Secondary outcomes

  1. HbA1c%

    Time frame: Change from Baseline HbA1c% at 6 months

    Hemoglobin A1C

  2. BMI

    Time frame: Change from Baseline Body Mass Index at 6 months

    Body Mass Index

  3. FBG

    Time frame: Change from Baseline Fasting glucose at 6 months

    Fasting blood glucose

  4. LDL

    Time frame: Change from Baseline LDL at 6 months

    Low-density lipoprotein

  5. HDL

    Time frame: Change from Baseline HDL at 6 months

    High-density lipoprotein

  6. waist circumference

    Time frame: Change from Baseline waist circumference at 6 months

    waist circumference

  7. Total cholesterol

    Time frame: Change from Baseline total cholesterol at 6 months

    Total cholesterol

  8. Triglyceride

    Time frame: Change from Baseline total triglyceride at 6 months

    triglyceride

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 28, 2022
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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