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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05545722
Other study ID # 2021-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date July 1, 2022

Study information

Verified date September 2022
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Research Method In the study, data will be collected by means of the data collection form, the diabetes strengthening scale, the diabetes self-management scale in people with type 2 diabetes, and based on the researcher's experiences and literature. 1. Data collection form: It will be created by the researcher based on the literature. (such as age, gender, how many years have had diabetes). 2. Diabetes strengthening scale: It has 3 sub-dimensions: management of psychosocial aspects in diabetes, level of dissatisfaction and readiness for change, setting and achieving diabetes goals. 3. Diabetes self-management scale for people with type 2 diabetes: The scale developed by has 3 sub-dimensions: healthy lifestyle, blood sugar management, and use of health services. High scores on the scale indicate good self-management, and low scores indicate poor self-management.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - • 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Tugba Bilgehan Çankaya Ankara

Sponsors (1)

Lead Sponsor Collaborator
Tugba Bilgehan

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Diabetes strengthening scale Diabetes strengthening scale: The maximum score that can be obtained from the scale is 140, and the minimum score is 28. High scores in scale scoring indicate high levels of reinforcement; low scores indicate low levels of empowerment. 12 weeks
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