Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

13 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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 de estudo

Observacional

Inscrição (Estimado)

450

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

  • Nome: Nina Mohorko

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Prevalence of nutrition disorders and nutrition-related conditions
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mini Nutritional Assessment (MNA)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Psychiatric Clinic Ljubljana

Colaboradores

University of Primorska

Investigadores

  • Investigador principal: Polona Rus Prelog, University Psychiatric Clinic Ljubljana

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de agosto de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de julho de 2026

Primeira postagem (Real)

17 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • UPCL-Geronto-2026-02
  • CRP 2025 No.: V3-2559 (Número de outro subsídio/financiamento: ARIS and the Ministry of Health)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Sri Lanka

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

Se inscrever