Valutazione All'Ingresso Del Rischio Nutrizionale in Pazienti Ricoverati Nel Reparto di Medicina Interna (AMIDO) (AMIDO)

July 10, 2024 updated by: Azienda Sanitaria Locale di Alessandria

Valutazione in Ingresso Del Rischio Nutrizionale Del Paziente in SC Medicina Interna Del P.O. di Acqui Terme in Regime di Ricovero: Presa in Carico Nutrizionale Per Ottimizzare l'Outcome di Patologia Acuta e Monitoraggio Nel Post-ricovero

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Malnutrition is defined as a nutritional state characterized by an excess or deficient intake of nutrients. This condition may result in a change in body composition and in organic disfunctions. Malnutrition in hospitalized patients is a condition prevalent worldwide affecting between 20% and 50% of patients at admission, with further increase expected during hospitalization. Patients hospitalized in internal medicine departments are frequently older with multimorbidity and polypharmacy, so very likely to be malnourished, but the prevalence and determinants of malnutrition remain unclear.

In AMIDO study, all patients with MUST 1 and 2 will be sent to the a 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.

Study Type

Interventional

Enrollment (Actual)

268

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Piedmont
      • Alessandria, Piedmont, Italy, 15121
        • Azienda Sanitaria Locale di Alessandria (ASL AL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutritional Intervention
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.
Diet changes with different dietary therapies, such as oral nutritional supports (ONS), extra nutritional cares, diet changes without supplements and artificial nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of malnutrition
Time Frame: Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical conditions and malnutrition
Time Frame: Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
Correlation between clinical outcomes of enrolled patients and level of malnutrition on admission, measured by MUST questionnaire
Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
Gender and malnutrition
Time Frame: Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)
Correlation between gender of enrolled patients and nutritional status at the time of admission, measured by MUST questionnaire
Before the intervention (Baseline/T0) and at the hospital discharge, an average of 8 days after (Final/T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paola Gnerre, MD, Azienda Sanitaria Locale di Alessandria (ASL AL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asl22.MedI.22.02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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