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临床试验/NCT05628259
NCT05628259已完成不适用

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

Pamukkale University6 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
6
主要终点
Diabetes Self-Management Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single blinding was provided that included inclusion criteria and agreement to participate in the study.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • have a physical disability.

研究组 & 干预措施

Control Group

No Intervention

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

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.

干预措施: Tele-Nursing based Motivational Interviewing (Behavioral)

结局指标

主要结局

Diabetes Self-Management Scale

时间窗: 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

时间窗: 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.

次要结局

  • Triglyceride(Change from Baseline total triglyceride at 6 months)
  • HbA1c%(Change from Baseline HbA1c% at 6 months)
  • BMI(Change from Baseline Body Mass Index at 6 months)
  • HDL(Change from Baseline HDL at 6 months)
  • waist circumference(Change from Baseline waist circumference at 6 months)
  • LDL(Change from Baseline LDL at 6 months)
  • Total cholesterol(Change from Baseline total cholesterol at 6 months)
  • FBG(Change from Baseline Fasting glucose at 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

EDA KILINÇ İŞLEYEN

Assistant Profesor Dr.

Pamukkale University

研究点 (6)

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