Skip to content

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

Investigation of the Validity, Reliability, and Responsiveness of BETY-Biopsychosocial Questionnaire in Individuals with Chronic Kidney Disease, on Dialysis, and Kidney Transplantation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06591702
Enrollment
150
Registered
2024-09-19
Start date
2024-02-21
Completion date
2026-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease(CKD), Chronic Kidney Disease Requiring Chronic Dialysis, Kidney Transplantation

Keywords

biopsychosocial model, validity and reliability, BETY-BQ, Chronic Kidney Disease, Kidney Transplantation, Dialysis

Brief summary

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.

Interventions

Questionnaire application

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Individuals with chronic kidney disease: Inclusion Criteria: * Being diagnosed with chronic kidney disease * To be over 18 years old * Consent of the participant

Exclusion criteria

* Acute infection * Being diagnosed with cancer Individuals on dialysis: Inclusion Criteria: * Being a dialysis patient * To be over 18 years old * Consent of the participant

Design outcomes

Primary

MeasureTime frameDescription
BETY-Biopsychosocial QuestionnaireThree monthsThe 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.

Secondary

MeasureTime frameDescription
Hospital Anxiety Depression ScaleThree monthsThe 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.
Kidney Disease and Quality of Life™ (KDQOL™-36)Three monthsThe 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.
Clinical Frailty ScaleThree monthsA 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.
Frail ScaleThree monthsThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactOrkun Tüfekçi, PT, PhD (c)
orkuntf@gmail.com5319502648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026