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Nutritional Status in Hospitalized Patients Over 65 Years of Age With Mental Disorders

Observational Malnutrition Sarcopenia Obesity Sarcopenic Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Malnutrition, Sarcopenia, Obesity, Sarcopenic Obesity. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Prevalence of nutrition disorders and nutrition-related conditions [Time frame: Baseline.]
Secondary outcome measures (12)
  • Mini Nutritional Assessment (MNA) [Time frame: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).]
  • Appendicular skeletal muscle mass index (ASMI) [Time frame: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).]
  • Gugging Swallowing Screen (GUSS) score [Time frame: Baseline and Day 21 (or hospital discharge if earlier).]
  • Phase angle [Time frame: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).]
  • Barthel Index score [Time frame: Baseline and Day 21 (or hospital discharge if earlier).]
  • Handgrip strength [Time frame: Baseline and Day 21 (or hospital discharge if earlier).]
  • Cognitive function [Time frame: Baseline and Day 21 (or hospital discharge if earlier).]
  • Geriatric Depression Scale (GDS) score [Time frame: Baseline and Day 21 (or hospital discharge if earlier).]
  • Hospital length of stay [Time frame: From admission to discharge, an average of 3 weeks.]
  • Number of participants experiencing at least one in-hospital adverse event [Time frame: During hospitalization, up to Day 21.]
  • De Morton Mobility Index score [Time frame: Baseline and Day 21 (or hospital discharge if earlier).]
  • 4-meter gait speed [Time frame: Baseline and Day 21 (or hospital discharge if earlier).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Bouillanne O, Morineau G, Dupont C, Coulombel I, Vincent JP, Nicolis I, Benazeth S, Cynober L, Aussel C. Geriatric Nutritional Risk Index: a new index for evaluating at-risk elderly medical patients. Am J Clin Nutr. 2005 Oct;82(4):777-83. doi: 10.1093/ajcn/82.4.777. PMID 16210706
  • Ruan Z, Li D, Huang D, Liang M, Xu Y, Qiu Z, Chen X. Relationship between an ageing measure and chronic obstructive pulmonary disease, lung function: a cross-sectional study of NHANES, 2007-2010. BMJ Open. 2023 Nov 2;13(11):e076746. doi: 10.1136/bmjopen-2023-076746. PMID 37918922

Identifiers

NCT: NCT07710456 · UPCL-Geronto-2026-02 · CRP 2025 No.: V3-2559

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗