- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06496984
Valutazione All'Ingresso Del Rischio Nutrizionale in Pazienti Ricoverati Nel Reparto di Medicina Interna (AMIDO) (AMIDO)
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Piedmont
-
Alessandria, Piedmont, Italy, 15121
- Azienda Sanitaria Locale di Alessandria (ASL AL)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Paola Gnerre, MD, Azienda Sanitaria Locale di Alessandria (ASL AL)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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