Clinical trial NCT06591962: The Comparison of Biopsychosocial Characteristics with and Without Diabetes Mellitus
Official title: The Comparison of Biopsychosocial Characteristics of Individuals with Diabetes Mellitus and Without Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
biopsychosocial model
BETY-BQ
validity and reliability
anxiety
depression
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of individuals who come to the university hospital for routine controls.

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.


Eligibility criteria: Individuals with Diabetes Mellitus

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Inclusion Criteria:

* Not having T2DM (other individuals followed up at Hacettepe University -
* Department of Internal Medicine)
* To be between 18-65 years old

Exclusion Criteria:

* 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

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire
timeFrame: Three months
Secondary outcomes:
measure: Hospital Anxiety Depression Scale (HADS)
timeFrame: Three months
measure: Turkish version of the Multidimensional Diabetes Questionnaire
timeFrame: Three months
measure: Summary of Diabetes Self-Care Activities
timeFrame: Three months
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Three months
measure: General Health Questionnaire (Euro QoL-5D)
timeFrame: Three months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: