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临床试验/NCT07710456
NCT07710456尚未招募不适用

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

University Psychiatric Clinic Ljubljana0 个研究点目标入组 450 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
450
主要终点
Prevalence of nutrition disorders and nutrition-related conditions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Prevalence of nutrition disorders and nutrition-related conditions

时间窗: 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.

次要结局

  • Mini Nutritional Assessment (MNA)(Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).)
  • Appendicular skeletal muscle mass index (ASMI)(Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).)
  • Gugging Swallowing Screen (GUSS) score(Baseline and Day 21 (or hospital discharge if earlier).)
  • Phase angle(Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).)
  • Barthel Index score(Baseline and Day 21 (or hospital discharge if earlier).)
  • Handgrip strength(Baseline and Day 21 (or hospital discharge if earlier).)
  • Cognitive function(Baseline and Day 21 (or hospital discharge if earlier).)
  • Geriatric Depression Scale (GDS) score(Baseline and Day 21 (or hospital discharge if earlier).)
  • Hospital length of stay(From admission to discharge, an average of 3 weeks.)
  • Number of participants experiencing at least one in-hospital adverse event(During hospitalization, up to Day 21.)
  • De Morton Mobility Index score(Baseline and Day 21 (or hospital discharge if earlier).)
  • 4-meter gait speed(Baseline and Day 21 (or hospital discharge if earlier).)
  • Five Times Sit-to-Stand Test(Baseline and Day 21 (or hospital discharge if earlier).)
  • Timed Up and Go Test (TUG)(Baseline and Day 21 (or hospital discharge if earlier).)
  • Clinical Frailty Scale (CFS)(Baseline and Day 21 (or hospital discharge if earlier).)
  • Age-adjusted Charlson Comorbidity Index (ACCI) score(Baseline.)
  • Number of regularly prescribed medications(Baseline.)
  • Geriatric Nutritional Risk Index (GNRI)(Baseline and Day 21 (or hospital discharge if earlier).)
  • Brain-derived neurotrophic factor (BDNF) concentration(Baseline and Day 21 (or hospital discharge if earlier).)
  • Interleukin-6 (IL-6) concentration(Baseline and Day 21 (or hospital discharge if earlier).)
  • Interleukin-1 beta (IL-1β) concentration(Baseline and Day 21 (or hospital discharge if earlier).)
  • Total antioxidant capacity(Baseline and Day 21 (or hospital discharge if earlier).)
  • Tumor necrosis factor alpha (TNF-alpha)(Baseline and Day 21 (or hospital discharge if earlier).)
  • C-reactive protein (CRP) concentration(Baseline and Day 21 (or hospital discharge if earlier).)
  • Phenotypic Age (PhenoAge)(Baseline and Day 21 (or hospital discharge if earlier).)
  • Skeletal muscle mass percentage(Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).)
  • Fat mass percentage(Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).)
  • Calf circumference(Baseline and Day 21 (or hospital discharge if earlier).)
  • Body mass index(Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).)

研究者

发起方
University Psychiatric Clinic Ljubljana
申办方类型
Other
责任方
Sponsor

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