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

NCT ID: NCT06591702

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-21

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Questionnaire study

Questionnaire application

Intervention Type OTHER

Other Intervention Names

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BETY-Biopsychosocial Questionnaire

Eligibility Criteria

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Inclusion Criteria

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


* Being a dialysis patient
* To be over 18 years old
* Consent of the participant


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

Exclusion Criteria

* Acute infection
* Being diagnosed with cancer

Individuals on dialysis:


* Acute infection
* Being diagnosed with cancer

Kidney transplant recipients:


* Acute infection
* Being diagnosed with cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Orkun Tüfekçi

Principal Investigator, PT, PhD(c)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Orkun Tüfekçi, PT, PhD (c)

Role: CONTACT

5319502648

Facility Contacts

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Orkun Tüfekçi, PT, PhD(c)

Role: primary

+90 312 305 25 25

Other Identifiers

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SBA 24/097

Identifier Type: -

Identifier Source: org_study_id

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