Evaluation of Depression Screening Methods Administered by Registered Nurses in Chronic Hemodialysis Patients

NCT07651436 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-07-23

No results posted yet for this study

Summary

Hemodialysis is a vital replacement therapy for patients with end-stage chronic kidney disease, but it imposes a heavy, demanding, and prolonged management, associated with a significant deterioration in quality of life. Hemodialysis patients are exposed to numerous physical, organizational, and social constraints, including repeated and prolonged sessions at the center, dietary and fluid restrictions, chronic fatigue, and frequent comorbidities. Therefore, depressive disorders in hemodialysis patients represent a major public health issue.

The literature reports a high prevalence of depressive symptoms among hemodialysis patients, ranging from 22% to 60%, significantly higher than that observed in the general population. These disorders are associated with a significant deterioration in quality of life, increased hospitalizations, lower therapeutic adherence, an increased risk of suicide, and excess mortality. Despite these important clinical consequences, depressive disorders often remain underdiagnosed in hemodialysis.

Current guidelines, including those from the Haute Autorité de Santé (HAS), emphasize the importance of regular quality of life assessments in patients with chronic kidney disease and recommend the use of validated questionnaires. However, they do not formalize a specific operational strategy for screening depressive disorders in routine hemodialysis practice, contributing to their under-evaluation.

The gold standard diagnosis of depressive disorders relies on a structured psychiatric interview, which is difficult to reconcile with the organizational constraints of dialysis centers. Standardized self-assessment tools, such as the Hospital Anxiety and Depression Scale (HADS), particularly its depression subscale (HADS-D), have been widely used. The HADS-D has the advantage of excluding somatic symptoms and has been validated in hemodialysis patients.

However, self-assessment relies on the patient's ability to express their subjective experience. Thus, the self-administration of standardized questionnaires in these patients is often challenging due to their age, comorbidities, fatigue, and functional limitations, often necessitating the intervention of healthcare staff. In contrast, registered nurses (IDE) working in hemodialysis possess longitudinal clinical knowledge of patients, acquired over repeated sessions, which can serve as a relevant lever for rapid and standardized screening of depressive symptoms. To date, the diagnostic performance of structured nursing hetero-evaluation remains poorly documented.

The IDE-3D study aims to evaluate the ability of nurses to identify depressive symptoms in hemodialysis patients using structured tools, comparing the nursing hetero-evaluation of the HADS-D with the self-assessment conducted by the patient. It is part of a pragmatic approach aimed at improving the screening of depressive disorders in hemodialysis, structuring the care pathway, and enhancing the integration of mental health into the overall management of hemodialysis patients.

Conditions

  • Depressive Disorders
  • End-stage Chronic Kidney Disease Treated With Hemodialysis

Interventions

OTHER

evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses

Interventional study with minimal risks and constraints. The main objective is to evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses in patients receiving in-center hemodialysis, compared to reference self-assessment tools completed by the patients.

Sponsors & Collaborators

  • GIRCI Auvergne Rhone-Alpes

    collaborator OTHER
  • SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation

    collaborator UNKNOWN
  • Centre Hospitalier Annecy Genevois

    lead OTHER

Principal Investigators

  • Cécile Herlet · Centre Hospitalier Annecy Genevois

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-26
Primary Completion
2028-06-30
Completion
2028-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07651436 on ClinicalTrials.gov