Investigation of the Validity, Reliability, and Responsiveness of BETY-BQ in Chronic Kidney Disease, on Dialysis, and Kidney Transplantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHacettepe University

About this trial

A review of the literature has shown that Chronic Kidney Disease (CKD) is strongly associated with an increasing degree of psychosocial impact, such as depression and anxiety and a decrease in quality of life. Therefore, while determining the psychosocial aspects of the disease gains importance, it is reported that determining and evaluating the biopsychosocial characteristics may facilitate the disease management of individuals. Considering that CKD is associated with various comorbidities, psychosocial features, and symptom burden, it is interpreted that patient-reported outcome measures may support the complex management of these individuals. Routine collection and use of patient-reported outcome measures may provide valuable data for understanding the disease from both individual and community perspectives, with the potential to improve the quality of care and outcomes.

The Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY) is an innovative exercise model based on physical exercise and an example of a biopsychosocial approach developed for patients with rheumatism. The BETY-Biopsychosocial Questionnaire (BETY-BQ) was created by repeated statistics of improvement characteristics reported by individuals who participated in BETY sessions for many years. The BETY-BQ holistically assesses many biopsychosocial characteristics of the person, such as pain, functionality, mood, sociability, sexuality, and sleep. Therefore, there is a need for scales that assess these symptoms holistically in chronic kidney disease. BETY-BQ can be envisaged as an assessment tool for interdisciplinary healthcare team members who want to evaluate the CKD population, including individuals on dialysis and kidney transplant recipients. Since the BETY-BQ can assess biopsychosocial characteristics quickly and its structure was created with the feedback of individuals with chronic diseases, it aimed to examine its validation in this disease group.

In this study, which investigators planned to contribute to this field, investigators aimed to investigate the validity, reliability, and sensitivity of BETY-BQ in individuals diagnosed with chronic kidney disease on dialysis and kidney transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being diagnosed with chronic kidney disease

To be over 18 years old

Consent of the participant

Disqualifiers

Acute infection

Being diagnosed with cancer

Being a dialysis patient

To be over 18 years old

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire study

    Other intervention

    Questionnaire application

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

BETY-Biopsychosocial Questionnaire

The biopsychosocial status is evaluated through questions about pain, functionality, mood, sociability, sexuality, and sleep. Each question has 30 items, with scores ranging from 0 to 120, categorized as follows: 0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), and 4 (yes always). Higher scores reflect a poorer biopsychosocial status.

Time frame
Three months

Secondary outcomes

1

Hospital Anxiety Depression Scale

The Hospital Anxiety and Depression Scale (HADS) comprises 14 items, with 7 items assessing anxiety and the other 7 evaluating depression. Each item is scored on a scale of 0 to 3, resulting in a total score ranging from 0 to 21. Higher scores indicate more severe levels of anxiety and depression.

Time frame
Three months
2

Kidney Disease and Quality of Life™ (KDQOL™-36)

The 36-item scale includes three specific dimensions: symptoms/problems, burden of kidney disease and effects of kidney disease, and physical component and mental component components derived from SF12. The scale, which consists of 5 sub-dimensions, is scored between 0-100. Higher scores indicate better health-related quality of life.

Time frame
Three months
3

Clinical Frailty Scale

A scale that can be easily administered in most clinical settings and is scored from 1 (very fit) to 9 (terminally ill) about fitness, active illness, activities of daily living, and cognition. The assessment is based on the subjective judgment of a clinician.

Time frame
Three months
4

Frail Scale

The FRAIL scale is based on a table of self-reported fatigue, mobility, strength, weight loss, and comorbidities. Each item is scored between 0-1, totaling 5 points. A high score indicates a high level of frailty.

Time frame
Three months

Other outcomes

Sponsors and contacts

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