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Набор скоро начнётся NCT07710456

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

Наблюдательное Malnutrition Sarcopenia Obesity Sarcopenic Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Malnutrition, Sarcopenia, Obesity, Sarcopenic Obesity. Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗