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

NCT06591702 | Recruiting

• 1 other identifier: SBA 24/097
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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.

  Three months

Secondary Outcomes (4)

• Hospital Anxiety Depression Scale

  Three months

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

  Three months

• Clinical Frailty Scale

  Three months

• Frail Scale

  Three months

Interventions

Questionnaire study OTHER

Questionnaire application

Also known as: BETY-Biopsychosocial Questionnaire

Eligibility Criteria

• Age: 18 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 diagnosed with chronic kidney disease
• To be over 18 years old
• Consent of the participant

You may not qualify if:

• Acute infection
• Being diagnosed with cancer
• Individuals on dialysis:
• Being a dialysis patient
• To be over 18 years old
• Consent of the participant
• Acute infection
• Being diagnosed with cancer
• Kidney transplant recipients:
• To have had a kidney transplant
• To be over 18 years old
• Consent of the participant
• Acute infection
• Being diagnosed with cancer

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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 8, 2024
• First Posted: September 19, 2024
• Study Start: February 21, 2024
• Primary Completion: February 21, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)