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

NCT06265181 | Not Yet Recruiting

• 1 other identifier: AIBU-SBF-SK-04
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes; Coaching; Self Management; Diabetes Distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diabetes Distress Scale

  3 months

• HbA1c Monitoring Form

  3 months

• Introductory Features Form

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Diabetes coaching

Control Group

NO INTERVENTION

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

Interventions

Diabetes coaching 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Saadet CAN ÇİÇEK, Assoc Prof.

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sinem KURTOĞLU, Phd Student

CONTACT

90 374 253 45 20; sinem.nehirrr@gmail.com

Saadet CAN ÇİÇEK, Assoc Prof.

CONTACT

90 374 253 45 20; saadet_can@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Experimental and control group.

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 20, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share