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临床试验/NCT07129083
NCT07129083已完成不适用

Exploring Predictors of Quality of Life in Older Adults With End-Stage Kidney Disease Receiving In-Center Hemodialysis: A Cross-Sectional Analysis of Sociodemographic, Dialysis-specific, Biopsychosocial, and Activity-Related Factors

University Ghent1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2018年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
111
试验地点
1
主要终点
Quality of Life - Amnestic Comparative Self-Assessment (ACSA)

研究概览

简要总结

This cross-sectional observational study investigates the overall quality of life (QoL) in adults aged 65 and older receiving in-center hemodialysis. While health-related quality of life (HRQoL) is commonly used in nephrology, it may not fully reflect what matters most to older patients. Using the Amnestic Comparative Self-Assessment (ACSA) as the primary measure, this study explores key determinants of QoL and examines how it relates to existing HRQoL tools (EQ-5D-3L, EORTC QLQ-C30, QLQ-MY20). Data are collected from four hospitals in Flanders, Belgium, using psychosocial (geriatric) assessments. Statistical analysis includes regression and cluster methods to identify predictors and patient subgroups. Results aim to inform more patient-centered care and improve QoL measurement in dialysis research.

详细描述

The global prevalence of end-stage kidney disease (ESKD) is steadily rising, with older adults representing the fastest-growing demographic in this patient population. In Europe, individuals aged 65 and older now account for over 52% of all incident ESKD cases. The primary treatment modality, in-center hemodialysis (ICHD), although life-sustaining, imposes a considerable treatment burden. This burden, when combined with the inherent symptom load of advanced kidney disease, often leads to a significant reduction in patients' overall well-being.

Compared to their younger counterparts, older adults on dialysis experience more complex clinical trajectories, characterized by multi-morbidity, increased frailty, and psychosocial vulnerability. Moreover, this population often faces challenges in adhering to the demanding schedules and lifestyle restrictions associated with dialysis. These factors collectively contribute to a reduction in overall quality of life (QoL), which patients often prioritize even over life expectancy.

Numerous studies have demonstrated that many older dialysis patients are willing to trade significant lengths of life expectancy, up to nine years in some cases, in exchange for better QoL. Despite this, QoL remains a vastly underutilized metric in nephrology clinical research. Only a small fraction of randomized controlled trials include QoL as an outcome measure, and even fewer consider it as a primary endpoint.

Health-Related Quality of Life (HRQoL), a narrower construct within the broader domain of QoL, is often used as a proxy for evaluating the well-being of patients. However, HRQoL tools may not fully capture what matters most to patients, especially during major life transitions such as dialysis initiation. Furthermore, differences in HRQoL instruments can produce inconsistent evaluations of patient outcomes and influence the estimation of quality-adjusted life years (QALYs), potentially skewing health policy decisions.

In light of these concerns, there is a need to examine overall QoL among older adults receiving dialysis, moving beyond standard HRQoL assessments to capture a more holistic and patient-centered understanding of life quality in this vulnerable population.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age 65 years or older
  • Receiving maintenance in-center hemodialysis (ICHD)
  • Able to provide informed consent
  • Sufficient cognitive capacity to understand and answer study questions
  • Fluent in Dutch (able to complete assessments in Dutch)

排除标准

  • Receiving ICHD due to an acute hospital admission (not chronic treatment)
  • Documented diagnosis of severe psychiatric illness or severe cognitive impairment (e.g., dementia)
  • Unable to understand or respond adequately to the questionnaire

结局指标

主要结局

Quality of Life - Amnestic Comparative Self-Assessment (ACSA)

时间窗: Baseline

A self-anchoring Quality of Life scale ranging from -5 (worst time in life) to +5 (best time in life). Participants reflect on their personal best and worst life periods and rate their current QoL accordingly.

次要结局

  • Risk of falls(Baseline)
  • Experienced level of pain(Baseline)
  • Vision impairment(Baseline)
  • Hearing impairment(Baseline)
  • Age(Baseline)
  • Marital status(Baseline)
  • Hospital admissions(Baseline)
  • Risk of dementia(Baseline)
  • Living situation(Baseline)
  • (Grand)children(Baseline)
  • Dialysis vintage(Baseline)
  • Nutritional risk(Baseline)
  • Continence problems(Baseline)
  • Frailty(Baseline)
  • Activity(Baseline)
  • Health-Related Quality of Life: EQ-5D-3L(Baseline)
  • Health-Related Quality of Life: EORTC QLQ-MY20(Baseline)
  • Health-Related Quality of Life using the EORTC QLQ-C30(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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