NCT06496984

Brief Summary

The aim of this study is to identify the risk of malnutrition in patients admitted to the Internal Medicine departments using the MUST screening tool. Additional aspects are to evaluate malnourished patients' characteristics and effectiveness of an early nutritional programme started during hospitalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
Last Updated

July 11, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

June 25, 2024

Last Update Submit

July 10, 2024

Conditions

MalnutritionHospitalized Patient

Outcome Measures

Primary Outcomes (1)

  • Risk of malnutrition

    Assessment of patients' risk of malnutrition on admission through the MUST questionnaire.

    Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)

Secondary Outcomes (2)

  • Clinical conditions and malnutrition

    Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)

  • Gender and malnutrition

    Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)

Study Arms (1)

Nutritional Intervention

EXPERIMENTAL

All patients with MUST 1 and 2 will be sent to the dietitian. The clinician will act on the patient's characteristics by providing different dietary therapies, such as oral nutritional supports (ONS), extra nutritional cares, diet changes without supplements and artificial nutrition.

Other: Nutritional intervention

Interventions

Nutritional interventionOTHER

Diet changes with different dietary therapies, such as oral nutritional supports (ONS), extra nutritional cares, diet changes without supplements and artificial nutrition.

Nutritional Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted from 1st January 2023 to 31th May 2023 at the Internal Medicine Department of the Monsignor Giovanni Galliano Hospital in Acqui Terme of the Alessandria ASL.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Sanitaria Locale di Alessandria (ASL AL)

Alessandria, Piedmont, 15121, Italy

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Paola Gnerre, MD

    Azienda Sanitaria Locale di Alessandria (ASL AL)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 11, 2024

Study Start

January 1, 2023

Primary Completion

May 31, 2023

Study Completion

December 31, 2023

Last Updated

July 11, 2024

Record last verified: 2024-06

Locations

IT(1)