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

NCT ID: NCT06265181

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-27
• Study Completion Date: 2027-12-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Diabetes coaching will be provided to experimental group participants. In this study, one chemistry interview and eight diabetes coaching meetings are planned to be held.

Interviews will be conducted in accordance with the standards of the GROW technique, which is based on a scientific framework. Interviews will be held every 10 days, via a video-free phone call, and will last between 45-60 minutes.

Group Type: EXPERIMENTAL

Diabetes coaching

Intervention Type: BEHAVIORAL

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.

Control Group

Diabetes treatment and care of the participants in this group will continue routinely, and no additional intervention will be performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Saadet Can Çiçek

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saadet CAN ÇİÇEK, Assoc Prof.

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Central Contacts

Sinem KURTOĞLU, Phd Student

Role: CONTACT

sinem.nehirrr@gmail.com

90 374 253 45 20

Saadet CAN ÇİÇEK, Assoc Prof.

Role: CONTACT

saadet_can@yahoo.com

90 374 253 45 20

Other Identifiers

AIBU-SBF-SK-04

Identifier Type: -

Identifier Source: org_study_id