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End Stage Renal Failure, HemodialysisB670201837264NCT07129083

Exploring Predictors of Quality of Life in Older Adults With End-Stage Kidney Disease Receiving In-Center Hemodialysis

An observational study of End Stage Renal Failure, Hemodialysis, run by University Ghent at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
End Stage Renal Failure, Hemodialysis
What is being tested?
Structured assessment interview
How many people
111 participants
Where
1 siteBelgium
Study dates
1 Jan 2018to 15 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Older adults with end-stage kidney disease undergoing maintenance in-center hemodialysis

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Ghent University Hospital

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

About this study

Official title: 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

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.

Read the detailed description

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.

This study aims to:

  • Identify the key determinants of overall QoL in older adults undergoing ICHD.
  • Examine how overall QoL relates to existing HRQoL measures.
  • Evaluate whether existing HRQoL instruments adequately capture domains that are meaningful to this population.
  • Explore natural groupings (clusters) of patients based on QoL and associated variables to inform future patient-centered interventions.

Study Design This is a cross-sectional, observational study reported in accordance with the Strengthening The Reporting of Observational Studies in Epidemiology (STROBE) guidelines. The study involves quantitative data collection through a structured assessment set administered face-to-face during dialysis sessions.

Participants are recruited from four hospitals in the Flanders region of Belgium between January and April 2018. Hospitals are selected to ensure a representative sample across urban, rural, academic, and regional settings.

Eligibility criteria include:

Age ≥65 years Receiving ICHD Able to provide informed consent Sufficient cognitive and language capacity to complete the questionnaire in Dutch

Exclusion criteria include:

Receiving dialysis due to an acute hospital admission Diagnosed with severe psychiatric or cognitive disorders (e.g., dementia) as documented in the medical record

Data Collection and Outcome Measures A total of 95 variables are assessed across multiple domains, guided by the International Classification of Functioning, Disability and Health (ICF) framework. Assessments are conducted during one to three consecutive dialysis sessions, depending on each participant's physical and cognitive condition. Each session lasts approximately 45 minutes.

An independent researcher with no clinical ties to the patient or dialysis unit conducts all interviews to reduce bias and minimize socially desirable responses.

Primary Outcome Measure Amnestic Comparative Self-Assessment (ACSA): A self-anchoring QoL rating scale ranging from -5 (worst period of life) to +5 (best period), based on the individual's life experiences. Participants reflect on the most positive and negative periods of their life and rate their current quality of life relative to these anchors. This tool allows for a highly individualized and sensitive measure of overall QoL.

Secondary Measures (Independent Variables) Sociodemographic Variables: Age, sex, education level, marital status, living situation Dialysis-Related Variables: Duration of dialysis, comorbidity index, dialysis adequacy Comprehensive Geriatric Assessment (CGA): Functional, psychological, and social domains including Fall Risk: STRATIFY scale, Psychological Measures: Geriatric Depression Scale (GDS-4), Nutritional Status: Nutritional Risk Screening (NRS-2002) Frailty Assessment: Groningen Frailty Indicator (GFI) Functional Status: Brussels Integrated Activity Scale (BIA) - measuring basic, instrumental, and advanced ADLs

HRQoL Instruments:

EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L) European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) EORTC QLQ-Myeloma Module (QLQ-MY20)

Statistical Analysis

All data are analyzed using SPSS (version 29.0.2.0). Missing values are handled using listwise deletion per questionnaire. The analysis is carried out in four stages:

  1. Descriptive Statistics: Means and standard deviations for normally distributed variables, medians and interquartile ranges for non-normal distributions. Normality assessed via Shapiro-Wilk test.
  2. Univariate Analyses: Mann-Whitney U test for dichotomous variables Kruskal-Wallis test for categorical variables with more than two groups Spearman's correlation for continuous and ordinal variables
  3. Multivariate Regression: Variables significantly associated with ACSA scores in univariate analysis are entered into a stepwise linear regression model to identify independent predictors of QoL.
  4. Cluster Analysis: Hierarchical clustering (Ward's method) is used to determine optimal grouping, followed by K-means clustering to explore patterns of QoL across patient subgroups.

Ethical Considerations This study was reviewed and approved by the Ethical Committee of Ghent University Hospital (B670201837264). All participants are fully informed of the study's purpose and procedures and provided both written and verbal informed consent. The study complies with the Declaration of Helsinki on ethical principles for medical research involving human subjects.

Significance and Expected Outcomes

This study offers an exploration of overall QoL in older adults receiving hemodialysis. By using the ACSA alongside commonly used HRQoL instruments and a wide range of biopsychosocial variables, the findings will help:

  1. Clarify which factors most strongly influence QoL in this population
  2. Reveal potential mismatches between standardized HRQoL measures and patients' lived experiences
  3. Inform future intervention design focused on improving well-being, not just clinical outcomes
  4. Provide empirical evidence to guide the choice of QoL instruments in research and policy evaluation, including cost-effectiveness studies

Ultimately, the study is expected to contribute to more patient-centered care models and improve the integration of QoL measures into nephrology research and clinical practice.

Being tested
Structured assessment interview
Keywords
End-stage Kidney Disease, Hemodialysis, Quality of Life, Older Adults
Medical subject headings
Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured assessment interviewOther

    Participants completed a structured, in-person assessment conducted during one to three dialysis sessions. The assessment included validated instruments to measure overall quality of life (ACSA), health-related quality of life (EQ-5D-3L, EORTC QLQ-C30, QLQ-MY20), and various clinical, psychological, functional, and sociodemographic factors.

Study groups in NCT07129083
Study groupRoleWhat they receive
Older adults receiving in-center hemodialysisAdults aged 65 years and older undergoing maintenance in-center hemodialysis at four hospitals in Flanders, Belgium. Participants completed structured assessments covering overall quality of life, health-related quality of life, clinical, functional, psychological, and sociodemographic variables.
Receives: Other: Structured assessment interview

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline

Secondary outcomes (18)
  1. Age

    Age (in years)

    Measured: Baseline

  2. Marital status

    Marital status (single, married, widowed)

    Measured: Baseline

  3. Living situation

    Living situation (independently alone, independently with family, in a care facility)

    Measured: Baseline

  4. (Grand)children

    (Grand)children (yes/no, number of children and grandchildren)

    Measured: Baseline

  5. Dialysis vintage

    Dialysis vintage up to baseline measure (in months)

    Measured: Baseline

  6. Hospital admissions

    Hospital admissions (amount in the last year)

    Measured: Baseline

  7. Risk of falls

    St. Thomas's Risk Assessment Tool in Falling Elderly Inpatients (STRATIFY); minimum score = 0, maximum score = 5; higher score indicates a higher risk of falling

    Measured: Baseline

  8. Risk of dementia

    Risk of dementia using Mini-Cog (full name); minimum score = 0, maximum score = 5; lower score is higher risk of dementia

    Measured: Baseline

  9. Nutritional risk

    Nutritional risk using the Nutritional Risk Screening 2002 (NRS-2002); minimum score = 0, maximum score = 7; lower score (<3) = lower nutritional risk

    Measured: Baseline

  10. Experienced level of pain

    Pain, measured using a VAS-scale (from 0= no pain, to 9= worst pain imaginable)

    Measured: Baseline

  11. Vision impairment

    Potential vision impairment, measured using two questions: 1. Do you have vision problems?; 2. Do you wear glasses?

    Measured: Baseline

  12. Hearing impairment

    Potential hearing impairment, measured using two questions: 1. Do you have hearing problems?; 2. Do you use hearing aids?

    Measured: Baseline

  13. Continence problems

    Potential continence problems, measured using two questions: 1. Do you have problems with continence?; 2. Do you use continence material?

    Measured: Baseline

  14. Frailty

    The Groningen Frailty Indicator (GFI), a multidimensional frailty measure; minimum score = 0, maximum score = 15; Higher score (≥4) implies (higher levels of) frailty

    Measured: Baseline

  15. Activity

    Brussels Integrated Activity Scale (BIA), measuring basic-, instrumental-, and advanced activities of daily living; Minimum score = 0 (completely dependent in all activities), maximum score = 54 (completely independent in all activities); Higher score = better functional status / greater independence

    Measured: Baseline

  16. Health-Related Quality of Life: EQ-5D-3L

    Health-related quality of life assessed using the EuroQol 5-Dimension 3-Level questionnaire (EQ-5D-3L); includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), rated at 3 levels (1= no problems, 2= some problems, 3= unable to/extreme problems). These can be converted into a utility score ranging from +- -0.59 to 1.00 (higher = better health). The EQ5D also includes a VAS-scale, where self-perceived health is rated from 0 (worst) to 100 (best)

    Measured: Baseline

  17. Health-Related Quality of Life using the EORTC QLQ-C30

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measures health-related quality of life through 5 functional, 9 symptom, and 1 global health status scale; minimum score = 0, maximum score = 100 (for functional scales, higher is better; for symptom scales, lower is better)

    Measured: Baseline

  18. Health-Related Quality of Life: EORTC QLQ-MY20

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20) measures functioning and symptoms; minimum scores = 0; maximum scores = 100; for all scales, a higher score = worse outcomes (unlike the QLQ-C30 where functional scales mean better functioning)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start1 Jan 2018
  3. Primary completion30 Dec 2018
  4. Study completion15 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07129083
Sponsor's protocol ID
BC-11716
Acronym
B670201837264
Status last verified
Aug 2025
First submitted
18 Jul 2025
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not applicable. There is no plan to share individual participant data.

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Failure, Hemodialysis, run by University Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life - Amnestic Comparative Self-Assessment (ACSA) (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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