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

13. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

450

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Nina Mohorko

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Prevalence of nutrition disorders and nutrition-related conditions
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mini Nutritional Assessment (MNA)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Psychiatric Clinic Ljubljana

Spolupracovníci

University of Primorska

Vyšetřovatelé

  • Vrchní vyšetřovatel: Polona Rus Prelog, University Psychiatric Clinic Ljubljana

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. srpna 2027

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

10. června 2026

První předloženo, které splnilo kritéria kontroly kvality

13. července 2026

První zveřejněno (Aktuální)

17. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. července 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • UPCL-Geronto-2026-02
  • CRP 2025 No.: V3-2559 (Jiné číslo grantu/financování: ARIS and the Ministry of Health)

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Studuje produkt zařízení regulovaný americkým úřadem FDA

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