Nutritional Status in Hospitalized Patients Over 65 Years of Age With Mental Disorders
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity Psychiatric Clinic Ljubljana
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 65 years and older
Presence of at least one psychiatric diagnosis
Hospitalization at the Geriatric Psychiatry Unit of the University Psychiatric Clinic Ljubljana
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Baseline.Secondary outcomes
1
Mini Nutritional Assessment (MNA)
Nutritional status will be assessed using the Mini Nutritional Assessment (MNA®; score range 0-30). Higher MNA scores indicate better nutritional status.
Time frame
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).2
Appendicular skeletal muscle mass index (ASMI)
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.
Time frame
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).3
Gugging Swallowing Screen (GUSS) score
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.
Time frame
Baseline and Day 21 (or hospital discharge if earlier).4
Phase angle
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.
Time frame
Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Psychiatric Clinic Ljubljana
Lead sponsor
University of Primorska
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: