NCT07129083

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

July 18, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

End-stage Kidney DiseaseHemodialysisQuality of LifeOlder Adults

Outcome Measures

Primary Outcomes (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.

    Baseline

Secondary Outcomes (18)

  • Age

    Baseline

  • Marital status

    Baseline

  • Living situation

    Baseline

  • (Grand)children

    Baseline

  • Dialysis vintage

    Baseline

  • +13 more secondary outcomes

Study Arms (1)

Older adults receiving in-center hemodialysis

Adults 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.

Other: Structured assessment interview

Interventions

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.

Older adults receiving in-center hemodialysis

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dominique Van d Van de Velde, Doctorate

    University Ghent

    PRINCIPAL INVESTIGATOR
  • Wim Van Biesen, Doctorate, MD

    University Ghent

    STUDY DIRECTOR
  • Patricia De Vriendt, Doctorate

    University Ghent

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 19, 2025

Study Start

January 1, 2018

Primary Completion

December 30, 2018

Study Completion

July 15, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Not applicable. There is no plan to share individual participant data.

Locations