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临床试验/NCT06265181
NCT06265181尚未招募不适用

Effect Of Diabetes Coaching on Diabetes Self-Management, Glycoslated Hemoglobin and Diabetes Distress Level in Indıviduals With Type 2 Diabetes: A Randomized Controlled Study

Abant Izzet Baysal University0 个研究点目标入组 64 人开始时间: 2024年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
主要终点
Type 2 Diabetes Self-Management Scale

研究概览

简要总结

This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.

The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program.

详细描述

Diabetes is a chronic and metabolic disease that develops when the body cannot secrete enough insulin or the cells cannot use insulin as they should, causing damage to many tissues and organs. It is estimated that there are 537 million adults aged 20-79 in the world with diabetes and this number will reach 783 million in 2045.

Diabetes distress, which is one of the most common mental concerns in individuals with diabetes, makes it difficult to achieve glycemic control, paves the way for the development of diabetes complications and reduces the quality of life. Diabetes distress also causes an increase in the risk of mortality and morbidity. One of the best ways to prevent or reduce diabetes distress is to provide self-management skills and support.

In recent years, health coaching has attracted attention in many countries for improving patients' self-management and providing the necessary behavioral change.

In this study, the effect of coaching intervention applied to individuals with diabetes on diabetes self-management, HbA1c and diabetes distress will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

When the researcher evaluates the participant according to the inclusion criteria, written consent will be obtained from the participant and pre-evaluation forms will be applied when compliance with the criteria is achieved. Afterwards, the participant's group will be notified to the researcher by the independent researcher and randomization will be carried out. With this; Data entries will be made by an independent researcher as group A and group B, without writing the group names. Until the data analysis and reporting is completed, the statistician will be blinded to which group is the intervention and which group is the control.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteering to participate in the study,
  • Having been diagnosed with Type 2 diabetes for at least 1 year,
  • Being between the ages of 18-65,
  • No communication problems,
  • Being literate,
  • Being able to use a phone (home or mobile phone),
  • Lack of diagnosis of psychiatric disease,
  • Not receiving hospital treatment due to acute problems,
  • Not to be involved in another study involving a similar intervention during the research period

排除标准

  • Being diagnosed with type 1 diabetes,
  • Type 2 diabetes diagnosis period is less than one year,
  • Being under 18 years of age, over 65 years of age,
  • Being pregnant,
  • Having a diagnosis of psychiatric disease,
  • Not agreeing to participate in the research

结局指标

主要结局

Type 2 Diabetes Self-Management Scale

时间窗: 3 months

This scale was developed by Koç and Özkan to evaluate self-management in type 2 diabetics and is a 5-point Likert type ("Always=5", "Often=4", "Sometimes=3") , "Rarely=2", "Never=1"). The sub-dimensions of the scale, which consists of a total of 19 questions; "Healthy Lifestyle Behaviors" (11 items), "Use of Health Services" (4 items) and "Blood Sugar Management" (4 items). The highest score that can be obtained from the scale is 95 and the lowest score is 19. As the score obtained from the scale increases, diabetes self-management increases. The Cronbach alpha value of the scale was calculated as 0.856 (37)

次要结局

  • Diabetes Distress Scale(3 months)
  • HbA1c Monitoring Form(3 months)
  • Introductory Features Form(3 months)

研究者

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

Saadet Can Çiçek

Associate Professor

Abant Izzet Baysal University

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