- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07465042
Symptom Clusters in Hemodialysis : Insights From a Multicenter Analysis Using Tetrachoric Correlations
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 :
- to identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering;
- to examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression.
Through this secondary analysis, we aim to clarify the internal architecture of symptom co-occurrence, identify key demographic drivers such as sex, and generate evidence supporting cluster-informed, individualized approaches to symptom assessment and management in routine nephrology care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69000
- CH Saint Joseph Saint Luc
-
Lyon, France, 69000
- Hcl Edouard Herriot
-
Lyon, France, 69000
- HCL Lyon Sud
-
Saint-Etienne, France, 42055
- ARTIC42
-
Sallanches, France, 74700
- CHAL
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Vienne, France, 38200
- CALYDIAL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- undergoing maintenance hemodialysis
- ≥18 years
- dialysis vintage ≥3 months
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
identify and characterize symptom clusters
Time Frame: one day enrollment
|
identify and characterize symptom clusters using tetrachoric correlations and hierarchical clustering
|
one day enrollment
|
|
examine associations between symptoms (and clusters) and comorbidity burden
Time Frame: one day enrollment
|
examine associations between symptoms (and clusters) and comorbidity burden, while assessing potential sex-specific patterns in symptom expression
|
one day enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Symptom Clusters in HD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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