NCT07710456

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
16mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jun 2026Dec 2027

Study Start

First participant enrolled

June 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 17, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 10, 2026

Last Update Submit

July 13, 2026

Conditions

MalnutritionSarcopeniaObesitySarcopenic ObesityFrailtyDysphagiaMental Disorder

Keywords

MalnutritionSarcopeniaFrailtyDysphagiaObesitySarcopenic ObesityMental DisorderElderly

Outcome Measures

Primary Outcomes (1)

  • Prevalence of nutrition disorders and nutrition-related conditions

    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.

Secondary Outcomes (29)

  • 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).

  • +24 more secondary outcomes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 16210706BACKGROUND

  • 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: 37918922BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

MalnutritionSarcopeniaObesityFrailtyDeglutition DisordersMental Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionBody WeightPathologic ProcessesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Polona Rus Prelog

    University Psychiatric Clinic Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vesna Simič

CONTACT

+38615872403vesna.simic@psih-klinika.si

Nina Mohorko

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2026

First Posted

July 17, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 17, 2026

Record last verified: 2026-06