Skip to main content
Clinical Trials/NCT06265181
NCT06265181
Not Yet Recruiting
N/A

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 sites64 target enrollmentMarch 27, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Abant Izzet Baysal University
Enrollment
64
Primary Endpoint
Type 2 Diabetes Self-Management Scale
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 27, 2024
End Date
December 31, 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saadet Can Çiçek

Associate Professor

Abant Izzet Baysal University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Type 2 Diabetes Self-Management Scale

Time Frame: 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)

Secondary Outcomes

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

Similar Trials