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

NCT07651436 | Recruiting

• 1 other identifier: 24-09
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Epidemiology; Diagnostic strategies; Mental health

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

The study is based on conducting parallel and independent assessments for the same patient.

OTHER

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

Interventions

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

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.

The study is based on conducting parallel and independent assessments for the same patient.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 who has already been included in this study
• Patient under guardianship, curatorship, or placed under judicial protection.

Sponsors & Collaborators

• Centre Hospitalier Annecy Genevois: lead
• GIRCI Auvergne Rhone-Alpes: collaborator
• SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation: collaborator

Study Sites (2)

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

RECRUITING

Centre Hospitalier Métropole Savoie

Chambéry, 73000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Cécile Herlet

  Centre Hospitalier Annecy Genevois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Rippoz

CONTACT

0033 4 85522120; arippoz@ch-annecygenevois.fr

DRCI CH Annecy Genevois

CONTACT

drci.promotion@ch-annecygenevois.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It will be a multicentric, prospective, non-randomized cohort 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 (HADS and PROMIS-29®). 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.

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)