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临床试验/NCT06591702
NCT06591702招募中不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
BETY-Biopsychosocial Questionnaire

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

BETY-Biopsychosocial Questionnaire

时间窗: Three months

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Orkun Tüfekçi

Principal Investigator, PT, PhD(c)

Hacettepe University

研究点 (1)

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