NCT05545722

Brief Summary

Diabetes Mellitus (DM) is an endocrine and metabolic disease that is characterized by hyperglycemia, develops microvascular and macrovascular complications, and requires chronic and continuous care. is a disease. According to IDF 2019 data, it is predicted that the number of diabetics in the world, which was 463 million in 2019, will reach 700 million in 2045 with an increase of 51%. The global prevalence of diabetes between the ages of 20-79 in 2019 is 9.3%, and it is estimated to increase to 10.2% in 2030 and 10.9% in 2045. Our country, on the other hand, has the highest prevalence with a rate of 11.1% among European countries. According to the IDF 2019 Diabetes Atlas data, 6.6 million people with diabetes live in our country as of 2019, and it is estimated that this rate will reach 10 million by 2045. American Diabetes Association (American Diabetes Association) and American Association of Clinical Endocrinologists (American Association of Clinical Endocrinologists) to achieve the goals of treatment and care in individuals with diabetes; emphasizes the need for regulation of nutrition, regulation of physical activity, regulation of pharmacological treatment, diabetes education, continuous monitoring and health controls. Individuals with diabetes should receive diabetes self-management education and support when necessary. Diabetes self-management is defined as the process of facilitating the knowledge, skills and abilities necessary for the individual's self-care. Individuals with diabetes who are competent and skilled in self-management can improve their health outcomes. The American Diabetes Association (ADA) defines diabetes self-management education as a process that begins at the diagnosis stage and continues, based on an individual-centered approach and making joint decisions to facilitate the knowledge, skills and abilities necessary for the self-care of diabetes patients. The purpose of diabetes self-management is for diabetics to develop new skills and behaviors that support self-management goals, and to form habits. The general goals of diabetes self-management education are to support individuals diagnosed with diabetes to make conscious decisions, solve problems, perform self-care behaviors, and improve their metabolic results, health status and quality of life. Diabetes patients need knowledge, skills and motivation to strengthen their diabetes by providing self-management. The nurse helps the patient to adapt to the disease and achieve the ability to perform self-care by counseling and training individuals. Coaching sessions are used to strengthen self-management and diabetes in diabetes. The coach is the person who provides the necessary motivation to maximize the strengths of the client, to ensure that the potentials are fully used through continuous education, to develop new skills and activities to be more effective, to be ready for new responsibilities and to manage himself. Life Coaching with Diabetes is based on the basic principles and principles of professional life coaching practices (ICF-International Coaching Federation), aiming at behavioral change in approaches related to diabetes lifestyle. Life coaching with diabetes is to give practical applications to people who have been diagnosed with diabetes in order to gain necessary changes in life through coaching. 2\. Problem and Sub-Problems H0: Diabetes life coaching given to individuals with Type 2 Diabetes has no effect on glycemic control, diabetes strengthening and self-management. H1: Diabetes life coaching given to individuals with Type 2 Diabetes has an effect on glycemic control, strengthening diabetes and self-management. 3\. Aims and Expected Benefits of the Research This study was planned as a control group intervention study to determine the effect of diabetes coaching on glycemic control, diabetes strengthening and self-management in individuals with Type 2 Diabetes. Expected benefits:

  • Developing appropriate self-care activities (physical activity, medical nutrition, drug management, avoiding risky behaviors, etc.) by improving the self-management skills of the individual with diabetes,
  • Individuals with diabetes become self-managed in their self-care practices,
  • Ensuring metabolic control of the diabetic individual
  • Developing decision-making and problem-solving skills of individuals with diabetes,
  • Promoting diabetes coaching in the nursing profession and increasing its visibility and spreading diabetes coaching.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

May 22, 2022

Last Update Submit

September 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • diabetes self-management skill scale

    Diabetes self-management scale in people with type 2 diabetes: The score that can be obtained from the scale is between 95-19. A high score from the scale indicates good self-management, and a low score indicates poor self-management.

    12 weeks

Secondary Outcomes (1)

  • Diabetes strengthening scale

    12 weeks

Study Arms (3)

life coaching group with diabetes

EXPERIMENTAL

Individuals with diabetes in the intervention 1 group will be interviewed for 'life coaching with diabetes'. Coaching is a set of systems that make people think deeply and reveal their own awareness and potential. A coach is a person who deliberately applies all these systems with awareness. Life coaching sessions with diabetes are based on the philosophy of coaching. Sessions are continued with questions that will enable the individual to realize the deficiencies in diabetes self-management. It helps the person with diabetes to discover solutions.This training will last for 3 months, once in 10 days. A total of 9 interviews will be provided.

Behavioral: life coaching group with diabetes

Standard diabetes education

EXPERIMENTAL

Standard diabetes education will be given to individuals with diabetes in this group. This training will last for 3 months, once in 10 days. A total of 9 interviews will be provided.

Behavioral: life coaching group with diabetes

control group

NO INTERVENTION

only pre-test and post-test were applied to this group. The patients in this group are the patient group who received training from the diabetes nurse of the hospital.

Interventions

Each patient was interviewed once a week. Coaching interviews were conducted one-on-one and in accordance with coaching principles.

Standard diabetes educationlife coaching group with diabetes

Eligibility Criteria

Age30 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient;
  • Being between the ages of 18-65,
  • Being literate,
  • Having a smart phone and being able to use it actively,
  • Having been diagnosed with type 2 diabetes at least 1 year ago,
  • No chronic complications related to diabetes have developed,
  • HbA1c \> 7,
  • Absence of any psychiatric or mental problems,
  • Having the cognitive competence to answer questions,
  • Willingness to participate in the research

You may not qualify if:

  • The patient's desire to leave the study,
  • Inability to reach the patient by phone
  • Having advanced retinopathy, nephropathy, neuropathy, foot wound,
  • Being pregnant,
  • Being diagnosed with cancer, having myocardial infarction in the last 3 months,
  • Having type 1 diabetes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Bilgehan

Çankaya, Ankara, 0060, Turkey (Türkiye)

Location

Related Publications (1)

  • Bilgehan T, Vardar Inkaya B. The effect of a holistic nurse coaching intervention on glycemic control, diabetes self-management, and empowerment: a randomized controlled trial. BMC Nurs. 2025 Jun 2;24(1):627. doi: 10.1186/s12912-025-03252-0.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 22, 2022

First Posted

September 19, 2022

Study Start

April 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations