The Comparison of Biopsychosocial Characteristics with and Without Diabetes Mellitus

NCT06591962 | Unknown

• 1 other identifier: Go 23/634
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

As it is a chronic disease, the lifelong disease duration and treatment process affect individuals with Type 2 Diabetes Mellitus (T2DM) biologically, psychologically, and socially by causing them to experience fatigue, increased stress, and life burden. Individuals with T2DM experience many psychosocial conditions leading to anxiety and depression as well as physical and functional effects. It has been reported that the fear of diabetic complications plays a vital role in depression, while individuals with diabetes with anxiety are more prone to depression. In addition, increased treatment cost burden has been reported among the psychological factors contributing to anxiety and depression in individuals with DM. One study reported that fatigue is commonly associated with increased anxiety, depression, and sleep problems in individuals with DM. A sedentary lifestyle in these individuals is noteworthy and has also been shown to be a contributing factor to depression. In addition to improving diabetic complications due to the disease, reducing depressive states and improving the psychosocial status of individuals may positively affect diabetes and reduce the symptoms and complications of T2DM. It has also been reported that increasing the self-efficacy of individuals with diabetes may positively impact the treatment. Based on this information, it is clear that there is a need for physical and psychosocial evaluation of individuals with T2DM in disease management. Therefore, determination of the biopsychosocial effects of individuals with T2DM in improving disease-specific findings and quality of life of individuals with T2DM to reflect positively on disease management processes is necessary for holistic management in treating these individuals. However, studies in this field are insufficient. This study aimed to compare individuals with and without T2DM biopsychosocial characteristics. The BETY-Biopsychosocial Questionnaire, which assesses the biopsychosocial status of individuals with rheumatism, has no validity in individuals with T2DM. Since the patient population and other scales to be used are common, it was considered to carry out the validity, reliability, and responsiveness study of this scale within the scope of this study.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; biopsychosocial model; BETY-BQ; validity and reliability; anxiety; depression

Outcome Measures

Primary Outcomes (1)

• BETY-Biopsychosocial Questionnaire

  The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status.

  Three months

Secondary Outcomes (5)

• Hospital Anxiety Depression Scale (HADS)

  Three months

• Turkish version of the Multidimensional Diabetes Questionnaire

  Three months

• Summary of Diabetes Self-Care Activities

  Three months

• Health Assessment Questionnaire (HAQ)

  Three months

• General Health Questionnaire (Euro QoL-5D)

  Three months

Study Arms (2)

Individuals diagnosed with diabetes mellitus

Individuals with diabetes mellitus admitted to the internal medicine outpatient clinic of a university hospital. A questionnaire will be applied for diabetes mellitus.

Other: Questionnaire application for diabetes mellitus

Individuals without a diagnosis of diabetes mellitus

Individuals without diabetes mellitus admitted to the internal medicine outpatient clinic of a university hospital. A questionnaire will be applied for without diabetes mellitus.

Other: Questionnaire application for without diabetes mellitus

Interventions

Questionnaire application for diabetes mellitus OTHER

Scales will be applied to individuals diagnosed with diabetes mellitus

Individuals diagnosed with diabetes mellitus

Questionnaire application for without diabetes mellitus OTHER

Scales will be applied to individuals diagnosed without diabetes mellitus

Individuals without a diagnosis of diabetes mellitus

Eligibility Criteria

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

Study Population

The study population will consist of individuals who come to the university hospital for routine controls.

You may qualify if:

• Being T2 DM
• To be between 18-65 years old

You may not qualify if:

• The patient has a diagnosis of autoimmune monogenic or drug-associated diabetes,
• Lack of consent of the participants,
• Frailty (Clinical Frailty Score; if greater than 3),
• Stroke, heart failure (NYHA stage 3 and above), unstable lung and cardiovascular diseases
• Individuals without Diabetes Mellitus
• Not having T2DM (other individuals followed up at Hacettepe University -
• Department of Internal Medicine)
• To be between 18-65 years old
• The patient has a diagnosis of autoimmune monogenic or drug-associated diabetes,
• Lack of consent of the participants,
• Frailty (Clinical Frailty Score; if greater than 3),
• Stroke, heart failure (NYHA stage 3 and above), unstable lung and cardiovascular diseases

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Orkun Tüfekçi, PT, PhD(c)

CONTACT

5319502648; orkuntf@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PT, PhD(c)

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: September 20, 2025
• Last Updated: September 19, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)