The Effect of Diabetes Coaching on Distress and Diabetes Self-Management

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06265181
• Other study ID #: AIBU-SBF-SK-04
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Abant Izzet Baysal University
• Contact: Sinem KURTOGLU, Phd Student
• Phone: 90 374 253 45 20
• Email: sinem.nehirrr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes coaching
Diabetes coaching intervention will be provided to the participants in the intervention group by the researcher, who is a specialist nurse who has received 140 hours of Level 2 Professional Coaching Training and 20 hours of diabetes coaching training. Since each individual's needs and values will be different, diabetes coaching interventions will be tailored specifically to the individual by the researcher within the general coaching framework, but by taking into account the individual's views, awareness, needs and current situation regarding self-management regarding diabetes. This flexibility, which supports the individual-specific approach within the coaching paradigm, is among the key elements in the success of coaching interventions (43). The individual will determine the coaching agenda according to his/her own needs.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 2 Diabetes Self-Management Scale	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)	3 months
Secondary	Diabetes Distress Scale	The Diabetes Distress Scale is a 17-item, 6-point Likert type scale developed by Polonsky et al. in 2005 to evaluate diabetes-specific distress. The scale consists of four subscales: emotional burden, doctor-related distress, treatment-related distress, and interpersonal distress. Each question in the scale is scored between 1 point and 6 points, and the scale evaluates the distress experienced by the individual in the last month (40). The validity and reliability study of the scale was conducted by Çakilli et al. in 2015, and the a value was found to be 0.88 for the entire scale and 0.90 for each of the subscales. The average total score of the scale is calculated by dividing the total score of the answers given to the scale by 17. A score of 3 points or higher suggests the presence of distress. Score calculation for the sub-dimensions is obtained by dividing the total score of the answers given to the questions by the number of questions in that section (40,41)	3 months
Secondary	HbA1c Monitoring Form	This is the form created to monitor the HbA1c values of individuals with diabetes before and after the application and to follow the changes (Annex 3). HbA1c is a routine test evaluated every three months in the follow-up of individuals with diabetes. Individuals will be included in the study if they have HbA1c tests within the last 10 days when they come to the Family Health Care, otherwise they will be included in the study when they have the test done on a date suitable for routine control.	3 months
Secondary	Introductory Features Form	The form was prepared by the researcher by conducting a literature review and consists of a total of 23 questions (32,34,37-39). In this form, in the first section; Questions about age, gender, education level, marital status, perceived income level, who the individual lives with, smoking and alcohol use, and the presence of chronic diseases. In the second part, there are questions about diabetes; duration of diabetes diagnosis, type of diabetes treatment, status of receiving diabetes education, HbA1c value measured in the last 10 days, presence and types of complications due to diabetes, regular use of diabetes medications, how diabetes care is carried out, status of receiving diabetes education (from whom, training subject , when it was taken, etc.) are included	3 months