Depressive DisordersIDE-3DNCT07651436
Evaluation of Depression Screening Methods Administered by Registered Nurses in Chronic Hemodialysis Patients
A study testing evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses in people with Depressive Disorders and End-stage Chronic Kidney Disease Treated With Hemodialysis, run by Centre Hospitalier Annecy Genevois at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorders, End-stage Chronic Kidney Disease Treated With Hemodialysis
- What is being tested?
- evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Jun 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
DRCI CH Annecy Genevois contact
France2 sites, 2 recruiting
- Recruiting
Centre Hospitalier Annecy Genevois
Annecy, 74370
Amelie PICHARD, 00 33 4 50 63 63 11, apichard@ch-annecygenevois.fr
Cécile Herlet
- Not yet recruiting
Centre Hospitalier Métropole Savoie
Chambéry, 73000
Marie-Christine CARRET, 00 33 4 79 96 58 13, mariechristine.carret@ch-metropole-savoie.fr
urc@ch-metropole-savoie.fr
About this study
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.
Read more
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.
- Being tested
- evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses
- Keywords
- Epidemiology, Diagnostic strategies, Mental health
- Medical subject headings
- Depressive Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nursesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of intervention (between one week and 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start26 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Annecy Genevois
- Sponsor type
- University, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes, SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation
- Responsible party
- Sponsor
- Investigators
- Cécile Herlet, Principal investigator, Centre Hospitalier Annecy Genevois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07651436
- Sponsor's protocol ID
- 24-09
- Other IDs
- 2026-A00547-44
- Acronym
- IDE-3D
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Depression Screening Methods Administered by Registered Nurses in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07651436
- Acronym / sponsor ID
- IDE-3D / 24-09
- Keywords
- Epidemiology, Diagnostic strategies, Mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Centre Hospitalier Annecy GenevoisUniversity, hospital or other
- Collaborators
- GIRCI Auvergne Rhone-Alpes, SFNDT - Société Francophone de Néphrologie, Dialyse et Transplantation
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The study is based on conducting parallel and independent assessments for the same patient. | Other | Other: evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nursesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nursesInterventional 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. | Other | The study is based on conducting parallel and independent assessments for the same patient. |
Primary outcome
The diagnostic performance of the hetero-assessment
Time frame: From enrollment to the end of intervention (between one week and 2 weeks)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DRCI CH Annecy Genevois contact
Cécile Herlet principal investigator
Centre Hospitalier Annecy Genevois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing evaluate the psychometric performance of different modalities of hetero-assessment of depressive symptoms by nurses in people with Depressive Disorders and End-stage Chronic Kidney Disease Treated With Hemodialysis, run by Centre Hospitalier Annecy Genevois at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Rippoz (0033 4 85522120, arippoz@ch-annecygenevois.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic performance of the hetero-assessment (time frame: From enrollment to the end of intervention (between one week and 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.