Clinical trial NCT06265181: The Effect of Diabetes Coaching on Distress and Diabetes Self-Management
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes
Coaching
Self Management
Diabetes Distress
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental and control group.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Type 2 Diabetes Self-Management Scale
timeFrame: 3 months
Secondary outcomes:
measure: Diabetes Distress Scale
timeFrame: 3 months
measure: HbA1c Monitoring Form
timeFrame: 3 months
measure: Introductory Features Form
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Abant Izzet Baysal University
name: Saadet CAN ÇİÇEK, Assoc Prof.
role: PRINCIPAL_INVESTIGATOR
References: