Evaluation of Depression Screening Methods Administered by Registered Nurses in Chronic Hemodialysis Patients (IDE-3D)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorders; End-stage Chronic Kidney Disease Treated With Hemodialysis
• Intervention / Treatment: Other: evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandra Rippoz; Phone Number: 0033 4 85522120; Email: arippoz@ch-annecygenevois.fr
• Study Contact Backup: Name: DRCI CH Annecy Genevois; Email: drci.promotion@ch-annecygenevois.fr

Study Locations

• France
  • Annecy, France, 74370
    • Centre Hospitalier Annecy Genevois
    • Contact: Cécile Herlet; Phone Number: 00 33 4 50 58 56 93; Email: cherlet@ch-annecygenevois.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient informed about the nature, process, and objectives of the study and having signed a free and informed consent to participate,
• Patient treated with conventional hemodialysis for at least 3 months and currently undergoing dialysis 3 times a week,
• Patient covered by the french national social welfare

Exclusion Criteria:

• Patient suffering from dementia
• Pregnant or breastfeeding patient
• Patient unable to understand the French language both orally and in writing, - making self-assessment impossible
• Patient currently participating in another interventional research protocol or in an exclusion period from such research
• Patient who has already been included in this study
• Patient under guardianship, curatorship, or placed under judicial protection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: The study is based on conducting parallel and independent assessments for the same patient.; The only intervention will resulting from the research consists of informing the responsible physician of the patient with an HADS-Depression score ≥ 8 to conduct a complementary clinical assessment and determine the appropriate management, according to the procedures in place at each center.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic performance of the hetero-assessment	For each patient, two HADS-Depression scores will be collected: One score resulting from the hetero-assessment performed by a nurse responsible for the patient, by filling out the 7 items of the depression subscale of the HADS, completed independently and autonomously, blind to the patient's responses, One score resulting from the self-assessment conducted by the patient, by completing the entire HADS questionnaire, considered as the reference method and completed blind to the nurse's responses. The diagnostic performance of the hetero-assessment by the nurse will be evaluated in terms of sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV).	From enrollment to the end of intervention (between one week and 2 weeks)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Annecy Genevois
• Collaborators: GIRCI Auvergne Rhone-Alpes; SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation
• Investigators: Principal Investigator: Cécile Herlet, Centre Hospitalier Annecy Genevois

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Epidemiology; Mental health; Diagnostic strategies
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Behavior; Personal Satisfaction; Depressive Disorder; Psychological Well-Being
• Other Study ID Numbers: 24-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No