Symptom Clusters in Hemodialysis : Insights From a Multicenter Analysis Using Tetrachoric Correlations

NCT07465042 | Completed DMC

• 1 other identifier: Symptom Clusters in HD
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 6

Brief Summary

In 2025, Guerraoui et al. published the Concordance Study in Clinical Kidney Journal, a large multicenter cross-sectional study embedded within the French REIN registry. This study compared symptoms reported by hemodialysis patients using the Dialysis Symptom Index (DSI) with clinician-perceived symptoms, revealing a high symptom burden and marked patient-clinician discordance \[3\]. The present work is a secondary analysis of the Concordance Study dataset. Building on the original findings, this analysis aims to deepen understanding of symptom organization and determinants in hemodialysis using multivariate and correlation-based approaches. Specifically, our objectives were :

1. 1.to identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering;
2. 2.to examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression.

Conditions

DIALYSIS SYMPTOMS AND ANXIETY; Hemodialysis

Keywords

hemodialysis; dialysis; symptoms; clinician-perceived symptoms; PROM

Outcome Measures

Primary Outcomes (2)

• identify and characterize symptom clusters

  identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering

  one day enrollment

• examine associations between symptoms (and clusters) and comorbidity burden

  examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression

  one day enrollment

Interventions

observational cross sectional study OTHER

no intervention : observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patients in six dialysis centres and self-dialysis units in the Rhône-Alpes region of France

You may qualify if:

• undergoing maintenance hemodialysis
• ≥18 years
• dialysis vintage ≥3 months

You may not qualify if:

• patients with cognitive impairment (which was assessed with the presence of either clinical judgement or formal diagnosis)
• patients who did not have the ability to express consent or refused to participant in the study
• patients who could not read or understand French well enough to complete the questionnaire.

Sponsors & Collaborators

• Calydial: lead

Study Sites (6)

CH Saint Joseph Saint Luc

Lyon, 69000, France

Location

HCL Edouard Herriot

Lyon, 69000, France

Location

HCL Lyon Sud

Lyon, 69000, France

Location

ARTIC42

Saint-Etienne, 42055, France

Location

CHAL

Sallanches, 74700, France

Location

CALYDIAL

Vienne, 38200, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 11, 2026
• Study Start: January 1, 2023
• Primary Completion: January 1, 2023
• Study Completion: December 31, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results

Locations

FR (6)