Clinical trial NCT06591702: Investigation of the Validity, Reliability, and Responsiveness of BETY-BQ in Chronic Kidney Disease, on Dialysis, and Kidney Transplantation
Official title: Investigation of the Validity, Reliability, and Responsiveness of BETY-Biopsychosocial Questionnaire in Individuals with Chronic Kidney Disease, on Dialysis, and Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
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: 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: 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

Exclusion Criteria:

* Acute infection
* Being diagnosed with cancer

Kidney transplant recipients:

Inclusion Criteria:

* To have had a kidney transplant
* To be over 18 years old
* Consent of the participant

Exclusion Criteria:

* Acute infection
* Being diagnosed with cancer

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire
timeFrame: Three months
Secondary outcomes:
measure: Hospital Anxiety Depression Scale
timeFrame: Three months
measure: Kidney Disease and Quality of Life™ (KDQOL™-36)
timeFrame: Three months
measure: Clinical Frailty Scale
timeFrame: Three months
measure: Frail Scale
timeFrame: Three months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References: