비만, 영양 실조, 여림, 근감소증, 삼킴곤란, 정신 이상에 대한 임상 시험 - 임상 시험 레지스트리

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

450

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Vesna Simič
전화번호: +38615872403
이메일: vesna.simic@psih-klinika.si

연구 연락처 백업

이름: Nina Mohorko

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Prevalence of nutrition disorders and nutrition-related conditions 기간: 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.	Baseline.

2차 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Psychiatric Clinic Ljubljana

협력자

University of Primorska

수사관

수석 연구원: Polona Rus Prelog, University Psychiatric Clinic Ljubljana

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 10일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

UPCL-Geronto-2026-02
CRP 2025 No.: V3-2559 (기타 보조금/기금 번호: ARIS and the Ministry of Health)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

결과 측정	측정값 설명	기간
Mini Nutritional Assessment (MNA) 기간: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).	Nutritional status will be assessed using the Mini Nutritional Assessment (MNA®; score range 0-30). Higher MNA scores indicate better nutritional status.	Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Appendicular skeletal muscle mass index (ASMI) 기간: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).	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.	Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Gugging Swallowing Screen (GUSS) score 기간: Baseline and Day 21 (or hospital discharge if earlier).	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.	Baseline and Day 21 (or hospital discharge if earlier).
Phase angle 기간: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).	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.	Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Barthel Index score 기간: Baseline and Day 21 (or hospital discharge if earlier).	Activities of daily living will be assessed using the Barthel Index. The total Barthel Index score (0-100 points) will be recorded. Higher scores indicate greater independence in activities of daily living.	Baseline and Day 21 (or hospital discharge if earlier).
Handgrip strength 기간: Baseline and Day 21 (or hospital discharge if earlier).	Handgrip strength will be assessed using a calibrated hand dynamometer. One maximal grip strength measurement will be obtained from the dominant hand and recorded in kilograms (kg). Higher values indicate greater handgrip strength.	Baseline and Day 21 (or hospital discharge if earlier).
Cognitive function 기간: Baseline and Day 21 (or hospital discharge if earlier).	Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30 points, with higher scores indicating better cognitive function.	Baseline and Day 21 (or hospital discharge if earlier).
Geriatric Depression Scale (GDS) score 기간: Baseline and Day 21 (or hospital discharge if earlier).	Depressive symptoms will be assessed using the 15-item Geriatric Depression Scale (GDS-15). The total score ranges from 0 to 15 points, with higher scores indicating more severe depressive symptoms.	Baseline and Day 21 (or hospital discharge if earlier).
Hospital length of stay 기간: From admission to discharge, an average of 3 weeks.	Hospital length of stay will be calculated as the number of calendar days from hospital admission to hospital discharge, based on the hospital medical record.	From admission to discharge, an average of 3 weeks.
Number of participants experiencing at least one in-hospital adverse event 기간: During hospitalization, up to Day 21.	The number of participants experiencing at least one predefined adverse event during hospitalization will be recorded. Predefined adverse events include falls, fractures, delirium, aspiration, pneumonia, urinary tract infection, gastrointestinal infection, sepsis, gastrointestinal bleeding, pressure ulcer, deep vein thrombosis, pulmonary embolism, arrhythmia, stroke, myocardial infarction, cardiopulmonary arrest, or death. Each participant will be counted once, irrespective of the number of adverse events experienced.	During hospitalization, up to Day 21.
De Morton Mobility Index score 기간: Baseline and Day 21 (or hospital discharge if earlier).	Mobility will be assessed using the de Morton Mobility Index (DEMMI). The DEMMI total score (0-100 points) will be recorded. Higher scores indicate better mobility.	Baseline and Day 21 (or hospital discharge if earlier).
4-meter gait speed 기간: Baseline and Day 21 (or hospital discharge if earlier).	Gait speed will be assessed over a 4-meter walking distance. Walking speed will be calculated as distance in meters divided by walking time in seconds and expressed in meters per second. Higher values indicate faster gait speed.	Baseline and Day 21 (or hospital discharge if earlier).
Five Times Sit-to-Stand Test 기간: Baseline and Day 21 (or hospital discharge if earlier).	Lower extremity muscle function will be assessed using the Five Times Sit-to-Stand Test (5STS). The time (seconds) required to complete five consecutive sit-to-stand repetitions will be recorded. Shorter completion time indicates better lower extremity strength.	Baseline and Day 21 (or hospital discharge if earlier).
Timed Up and Go Test (TUG) 기간: Baseline and Day 21 (or hospital discharge if earlier).	Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time (seconds) required to stand up from a chair, walk around a marker, return, and sit down will be recorded. Shorter completion time indicates better function.	Baseline and Day 21 (or hospital discharge if earlier).
Clinical Frailty Scale (CFS) 기간: Baseline and Day 21 (or hospital discharge if earlier).	Frailty will be assessed using the Clinical Frailty Scale (CFS), ranging from 1 to 9 points. Higher scores indicate greater frailty.	Baseline and Day 21 (or hospital discharge if earlier).
Age-adjusted Charlson Comorbidity Index (ACCI) score 기간: Baseline.	Comorbidity burden will be assessed using the Age-adjusted Charlson Comorbidity Index. The total ACCI score will be recorded.	Baseline.
Number of regularly prescribed medications 기간: Baseline.	The number of regularly prescribed systemic medications documented in the participant's medication list at baseline will be recorded. Medications prescribed only as needed will not be included.	Baseline.
Geriatric Nutritional Risk Index (GNRI) 기간: Baseline and Day 21 (or hospital discharge if earlier).	GNRI will be calculated from serum albumin concentration and the ratio of actual to ideal body weight using the prespecified GNRI equation (Bouillanne et al, 2005). The GNRI is a unitless score, with higher scores indicating lower nutrition-related risk.	Baseline and Day 21 (or hospital discharge if earlier).
Brain-derived neurotrophic factor (BDNF) concentration 기간: Baseline and Day 21 (or hospital discharge if earlier).	Serum brain-derived neurotrophic factor (BDNF) concentration will be measured in serum obtained from venous blood using a validated enzyme-linked immunosorbent assay and expressed in ng/ml.	Baseline and Day 21 (or hospital discharge if earlier).
Interleukin-6 (IL-6) concentration 기간: Baseline and Day 21 (or hospital discharge if earlier).	Serum interleukin-6 (IL-6) concentration will be measured in serum obtained from venous blood using a validated laboratory assay and expressed in pg/ml.	Baseline and Day 21 (or hospital discharge if earlier).
Interleukin-1 beta (IL-1β) concentration 기간: Baseline and Day 21 (or hospital discharge if earlier).	Serum interleukin-1 beta (IL-1β) concentration (pg/ml) will be measured in serum obtained from venous blood using a validated laboratory assay.	Baseline and Day 21 (or hospital discharge if earlier).
Total antioxidant capacity 기간: Baseline and Day 21 (or hospital discharge if earlier).	Total antioxidant capacity, assessed using the DPPH radical scavenging assay, will be expressed as percentage inhibition of the DPPH radical. Higher values indicate greater antioxidant capacity.	Baseline and Day 21 (or hospital discharge if earlier).
Tumor necrosis factor alpha (TNF-alpha) 기간: Baseline and Day 21 (or hospital discharge if earlier).	Serum tumor necrosis factor-alpha (TNF-α) concentration (pg/ml) will be measured in serum obtained from venous blood using a validated laboratory assay.	Baseline and Day 21 (or hospital discharge if earlier).
C-reactive protein (CRP) concentration 기간: Baseline and Day 21 (or hospital discharge if earlier).	Serum C-reactive protein (CRP) concentration (mg/l) will be measured in serum obtained from venous blood using routine laboratory methods.	Baseline and Day 21 (or hospital discharge if earlier).
Phenotypic Age (PhenoAge) 기간: Baseline and Day 21 (or hospital discharge if earlier).	PhenoAge, expressed in years, will be calculated using the validated equation described by Ruan et al. (2023), based on chronological age, serum albumin, creatinine, glucose, lymphocyte percentage, mean corpuscular volume, red cell distribution width, alkaline phosphatase, and white blood cell count. Lower values indicate lower biological age.	Baseline and Day 21 (or hospital discharge if earlier).
Skeletal muscle mass percentage 기간: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).	Skeletal muscle mass percentage will be assessed by bioelectrical impedance analysis and expressed as the percentage of total body mass classified as skeletal muscle mass.	Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Fat mass percentage 기간: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).	Fat mass percentage will be assessed by bioelectrical impedance analysis and expressed as the percentage of total body mass classified as fat mass. Higher values indicate a greater proportion of body fat.	Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).
Calf circumference 기간: Baseline and Day 21 (or hospital discharge if earlier).	Calf circumference will be measured in centimeters at the prespecified anatomical site using a non-stretch measuring tape and standardized anthropometric procedures.	Baseline and Day 21 (or hospital discharge if earlier).
Body mass index 기간: Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).	Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and expressed in kg/m².	Baseline, Day 7, Day 14, and Day 21 (or hospital discharge if earlier).

Nutritional Status in Hospitalized Patients Over 65 Years of Age With Mental Disorders (NutriP-SI65)

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