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Nutritional Status in Hospitalized Patients Over 65 Years of Age With Mental Disorders (NutriP-SI65)

13 luglio 2026 aggiornato da: University Psychiatric Clinic Ljubljana

Nutritional Status, Nutrition-Related Conditions, and Development of a Clinical Pathway for Nutritional Support in Hospitalized Patients Aged 65 Years and Older With Mental Disorders

The objective of of this observational study is to evaluate the nutritional status and the prevalence of nutrition-related conditions, as well as dysphagia, among patients aged 65 years and older with mental disorders. The study will also identify key associated factors and inform the development of targeted strategies for the prevention, early identification, and management of malnutrition and related conditions. Furthermore, a draft clinical pathway for nutritional care will be developed, and its feasibility and effectiveness will be assessed.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

This prospective observational study will be conducted at the Geriatric Psychiatry Unit of the University Psychiatric Clinic Ljubljana and will focus on hospitalized patients aged 65 years and older with mental disorders. Older adults with psychiatric conditions, particularly those with dementia and depression, represent a highly vulnerable population with an increased risk of malnutrition, dysphagia, and related clinical conditions. Despite their clinical importance, these conditions remain under-recognized and insufficiently addressed, particularly in hospital settings, where nutritional status may further deteriorate during admission.

The study aims to provide a comprehensive and systematic evaluation of nutritional status and nutrition-related conditions in this population, while also examining their relationship with clinical, functional, cognitive, psychological, and sociodemographic factors. In addition, the study will explore associations between nutritional conditions and laboratory biomarkers, including markers of inflammation, metabolism, and oxidative stress, to improve understanding of underlying pathophysiological mechanisms.

Data will be collected as part of routine clinical care using a multidisciplinary approach, including medical, nutritional, functional, psychological, and pharmacological assessments. Nutritional status and dysphagia will be evaluated using validated clinical tools and standard diagnostic criteria. Functional status will be assessed through established mobility and performance measures, while cognitive function and mood will be evaluated using standardized psychological instruments. Laboratory parameters will be obtained from routine diagnostics, with additional analyses performed on stored serum samples without increasing patient burden.

Patients will be assessed at hospital admission and followed during hospitalization, with repeated measurements performed in accordance with standard clinical practice. No additional invasive procedures will be performed solely for research purposes, and all participants will receive standard care according to current clinical guidelines. The study will therefore not interfere with treatment or impose additional risk to participants.

The findings of this study are expected to provide the first comprehensive national data on the prevalence of malnutrition and related conditions in hospitalized older adults with mental disorders in Slovenia. Based on these findings, a multidisciplinary clinical pathway for nutritional care will be developed and its feasibility and effectiveness evaluated. The results will contribute to improved early detection, prevention, and management of malnutrition and dysphagia, as well as to the development of national evidence-based clinical guidelines and healthcare strategies for this vulnerable population.

Tipo di studio

Osservativo

Iscrizione (Stimato)

450

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Nina Mohorko

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population will consist of patients aged 65 years and older who are admitted to inpatient wards of the unit, have at least one psychiatric diagnosis, and have an expected hospitalization of at least 48 hours. Only patients who provide written informed consent, or whose legal representatives provide consent, will be included.

Descrizione

Inclusion Criteria:

  • Age 65 years and older
  • Presence of at least one psychiatric diagnosis
  • Hospitalization at the Geriatric Psychiatry Unit of the University Psychiatric Clinic Ljubljana

Exclusion Criteria:

  • Individuals who did not provide written informed consent (or whose legal representatives did not provide consent)
  • Hospitalization shorter than 48 hours
  • Presence of delirium
  • Patients receiving palliative care or who are terminally ill

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of nutrition disorders and nutrition-related conditions
Lasso di tempo: Baseline.
The prevalence of predefined nutrition disorders and nutrition-related conditions will be assessed in hospitalized patients aged 65 years and older with mental disorders using validated diagnostic criteria. Predefined conditions include malnutrition, cachexia, sarcopenia, frailty, overweight, obesity (including sarcopenic obesity and central obesity), and micronutrient abnormalities.
Baseline.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mini Nutritional Assessment (MNA)
Lasso di tempo: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Nutritional status will be assessed using the Mini Nutritional Assessment (MNA®; score range 0-30). Higher MNA scores indicate better nutritional status.
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Appendicular skeletal muscle mass index (ASMI)
Lasso di tempo: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Appendicular skeletal muscle mass index (ASMI, kg/m²) will be assessed by bioelectrical impedance analysis and calculated as appendicular skeletal muscle mass in kilograms divided by height in meters squared. Higher ASMI values indicate greater appendicular skeletal muscle mass relative to height.
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Gugging Swallowing Screen (GUSS) score
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Dysphagia will be assessed using the Gugging Swallowing Screen (GUSS). The total score ranges from 0 to 20 points, with higher scores indicating better swallowing function. Established score ranges will be used to describe dysphagia severity.
Baseline and Day 21 (or hospital discharge if earlier).
Phase angle
Lasso di tempo: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Phase angle, expressed in degrees, will be assessed using bioelectrical impedance analysis. Higher phase angle values generally indicate greater cell membrane integrity and body cell mass.
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Barthel Index score
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Activities of daily living will be assessed using the Barthel Index. The total Barthel Index score (0-100 points) will be recorded. Higher scores indicate greater independence in activities of daily living.
Baseline and Day 21 (or hospital discharge if earlier).
Handgrip strength
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Handgrip strength will be assessed using a calibrated hand dynamometer. One maximal grip strength measurement will be obtained from the dominant hand and recorded in kilograms (kg). Higher values indicate greater handgrip strength.
Baseline and Day 21 (or hospital discharge if earlier).
Cognitive function
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30 points, with higher scores indicating better cognitive function.
Baseline and Day 21 (or hospital discharge if earlier).
Geriatric Depression Scale (GDS) score
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15). The total score ranges from 0 to 15 points, with higher scores indicating more severe depressive symptoms.
Baseline and Day 21 (or hospital discharge if earlier).
Hospital length of stay
Lasso di tempo: From admission to discharge, an average of 3 weeks.
Hospital length of stay will be calculated as the number of calendar days from hospital admission to hospital discharge, based on the hospital medical record.
From admission to discharge, an average of 3 weeks.
Number of participants experiencing at least one in-hospital adverse event
Lasso di tempo: During hospitalization, up to Day 21.
The number of participants experiencing at least one predefined adverse event during hospitalization will be recorded. Predefined adverse events include falls, fractures, delirium, aspiration, pneumonia, urinary tract infection, gastrointestinal infection, sepsis, gastrointestinal bleeding, pressure ulcer, deep vein thrombosis, pulmonary embolism, arrhythmia, stroke, myocardial infarction, cardiopulmonary arrest, or death. Each participant will be counted once, irrespective of the number of adverse events experienced.
During hospitalization, up to Day 21.
De Morton Mobility Index score
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Mobility will be assessed using the de Morton Mobility Index (DEMMI). The DEMMI total score (0-100 points) will be recorded. Higher scores indicate better mobility.
Baseline and Day 21 (or hospital discharge if earlier).
4-meter gait speed
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Gait speed will be assessed over a 4-meter walking distance. Walking speed will be calculated as distance in meters divided by walking time in seconds and expressed in meters per second. Higher values indicate faster gait speed.
Baseline and Day 21 (or hospital discharge if earlier).
Five Times Sit-to-Stand Test
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Lower extremity muscle function will be assessed using the Five Times Sit-to-Stand Test (5STS). The time (seconds) required to complete five consecutive sit-to-stand repetitions will be recorded. Shorter completion time indicates better lower extremity strength.
Baseline and Day 21 (or hospital discharge if earlier).
Timed Up and Go Test (TUG)
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time (seconds) required to stand up from a chair, walk around a marker, return, and sit down will be recorded. Shorter completion time indicates better function.
Baseline and Day 21 (or hospital discharge if earlier).
Clinical Frailty Scale (CFS)
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Frailty will be assessed using the Clinical Frailty Scale (CFS), ranging from 1 to 9 points. Higher scores indicate greater frailty.
Baseline and Day 21 (or hospital discharge if earlier).
Age-adjusted Charlson Comorbidity Index (ACCI) score
Lasso di tempo: Baseline.
Comorbidity burden will be assessed using the Age-adjusted Charlson Comorbidity Index. The total ACCI score will be recorded.
Baseline.
Number of regularly prescribed medications
Lasso di tempo: Baseline.
The number of regularly prescribed systemic medications documented in the participant's medication list at baseline will be recorded. Medications prescribed only as needed will not be included.
Baseline.
Geriatric Nutritional Risk Index (GNRI)
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
GNRI will be calculated from serum albumin concentration and the ratio of actual to ideal body weight using the prespecified GNRI equation (Bouillanne et al, 2005). The GNRI is a unitless score, with higher scores indicating lower nutrition-related risk.
Baseline and Day 21 (or hospital discharge if earlier).
Brain-derived neurotrophic factor (BDNF) concentration
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Serum brain-derived neurotrophic factor (BDNF) concentration will be measured in serum obtained from venous blood using a validated enzyme-linked immunosorbent assay and expressed in ng/ml.
Baseline and Day 21 (or hospital discharge if earlier).
Interleukin-6 (IL-6) concentration
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Serum interleukin-6 (IL-6) concentration will be measured in serum obtained from venous blood using a validated laboratory assay and expressed in pg/ml.
Baseline and Day 21 (or hospital discharge if earlier).
Interleukin-1 beta (IL-1β) concentration
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Serum interleukin-1 beta (IL-1β) concentration (pg/ml) will be measured in serum obtained from venous blood using a validated laboratory assay.
Baseline and Day 21 (or hospital discharge if earlier).
Total antioxidant capacity
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Total antioxidant capacity, assessed using the DPPH radical scavenging assay, will be expressed as percentage inhibition of the DPPH radical. Higher values indicate greater antioxidant capacity.
Baseline and Day 21 (or hospital discharge if earlier).
Tumor necrosis factor alpha (TNF-alpha)
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Serum tumor necrosis factor-alpha (TNF-α) concentration (pg/ml) will be measured in serum obtained from venous blood using a validated laboratory assay.
Baseline and Day 21 (or hospital discharge if earlier).
C-reactive protein (CRP) concentration
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Serum C-reactive protein (CRP) concentration (mg/l) will be measured in serum obtained from venous blood using routine laboratory methods.
Baseline and Day 21 (or hospital discharge if earlier).
Phenotypic Age (PhenoAge)
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
PhenoAge, expressed in years, will be calculated using the validated equation described by Ruan et al. (2023), based on chronological age, serum albumin, creatinine, glucose, lymphocyte percentage, mean corpuscular volume, red cell distribution width, alkaline phosphatase, and white blood cell count. Lower values indicate lower biological age.
Baseline and Day 21 (or hospital discharge if earlier).
Skeletal muscle mass percentage
Lasso di tempo: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Skeletal muscle mass percentage will be assessed by bioelectrical impedance analysis and expressed as the percentage of total body mass classified as skeletal muscle mass.
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Fat mass percentage
Lasso di tempo: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Fat mass percentage will be assessed by bioelectrical impedance analysis and expressed as the percentage of total body mass classified as fat mass. Higher values indicate a greater proportion of body fat.
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Calf circumference
Lasso di tempo: Baseline and Day 21 (or hospital discharge if earlier).
Calf circumference will be measured in centimeters at the prespecified anatomical site using a non-stretch measuring tape and standardized anthropometric procedures.
Baseline and Day 21 (or hospital discharge if earlier).
Body mass index
Lasso di tempo: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and expressed in kg/m².
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Psychiatric Clinic Ljubljana

Collaboratori

University of Primorska

Investigatori

  • Investigatore principale: Polona Rus Prelog, University Psychiatric Clinic Ljubljana

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UPCL-Geronto-2026-02
  • CRP 2025 No.: V3-2559 (Altro numero di sovvenzione/finanziamento: ARIS and the Ministry of Health)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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