Prevalence and Clinical-Economic Aspects of Malnutrition in Rehabilitation

NCT ID: NCT07183098

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

193 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-15

Study Completion Date

2022-12-31

Brief Summary

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The goal of this observational study is to learn about the clinical and economic aspects of specialized nutritional care in participiants at high risk of malnutrition (Malnutrition Universal Screening Tool-MUST equal or higher than 2) admitted to a rehabilitation hospital. The main questions it aim to answer are:

* Does a specialized nutritional care lower hospital readmission rate at three months post-discharge in participiants at high risk of malnutrition admitted to a rehabilitation hospital?
* Does a specialized nutritional care lower the number of emergency department admissions, number of general practitioner (GP) and outpatient visits, number of diagnostic tests and daily medication use and mortality rate in participiants at high risk of malnutrition admitted to a rehabilitation hospital?

Participiants at high risk of malnutrition, three months after discharge were monitored through telephone interview about the hospital readmission and mortality rate, the number of emergency department admissions, GP and outpatient visits, diagnostic tests and daily medication use for treatment burden.

Detailed Description

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Conditions

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Rehabilitation Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participiants at high risk of malnutrition admitted to a rehabilitation hospital

Participiants at high risk of malnutrition who received standard nutritional care were compared with participiants at high risk of malnutrition who received specialized nutritional care

Participiants at high risk of malnutrition who received standard nutritional care

Intervention Type OTHER

The overall clinical managment of people by ward's staff includes also nutritional care. Within 24-48 h after hospitalization, the ward's nursing staff screens people for nutritional risk using the Malnutrition Universal Screening Tool (MUST) tool. The attending ward's physician prescribes nutritional support and laboratory analyses in accordance with people's clinical needs and the underlying disease. Ward's physician cllinical judgement guides the decision to reassess and monitor the people's nutritional risk and status.

Participiants at high risk of malnutrition who received specialized nutritional care

Intervention Type OTHER

People referred to the Dietetic and Clinical Nutrition Service (DCNS) receive a structured, evidence-based diagnostic and therapeutic nutritional support. A dietitian performs a dietary assessment and the attending physicians of the DCNS prescribe a baseline set of laboratory analyses relevant for nutritional status. People referred to the DCNS are monitored regularly and systematically, daily or weekly according to the people's clinical condition and nutritional problems.

3 month-post discharge evaluation

Intervention Type OTHER

Three months after discharge (follow-up), participiants of both groups were monitored through telephone interview to collect data regarding rate of hospital readmission, number of emergency department admissions, general practitioner visits, outpatient visits, diagnostic tests, daily medication use and survival.

Interventions

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Participiants at high risk of malnutrition who received standard nutritional care

The overall clinical managment of people by ward's staff includes also nutritional care. Within 24-48 h after hospitalization, the ward's nursing staff screens people for nutritional risk using the Malnutrition Universal Screening Tool (MUST) tool. The attending ward's physician prescribes nutritional support and laboratory analyses in accordance with people's clinical needs and the underlying disease. Ward's physician cllinical judgement guides the decision to reassess and monitor the people's nutritional risk and status.

Intervention Type OTHER

Participiants at high risk of malnutrition who received specialized nutritional care

People referred to the Dietetic and Clinical Nutrition Service (DCNS) receive a structured, evidence-based diagnostic and therapeutic nutritional support. A dietitian performs a dietary assessment and the attending physicians of the DCNS prescribe a baseline set of laboratory analyses relevant for nutritional status. People referred to the DCNS are monitored regularly and systematically, daily or weekly according to the people's clinical condition and nutritional problems.

Intervention Type OTHER

3 month-post discharge evaluation

Three months after discharge (follow-up), participiants of both groups were monitored through telephone interview to collect data regarding rate of hospital readmission, number of emergency department admissions, general practitioner visits, outpatient visits, diagnostic tests, daily medication use and survival.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Admission to the rehabilitation hospital IRCCS Fondazione Don Carlo Gnocchi ONLUS, Florence
* high risk of malnutrition (Malnutrition Universal Screening Tool-MUST equal or higher than 2)

Exclusion Criteria

* age under 50 years;
* oncological diagnosis associated with a poor six-month prognosis and/or with advanced or irreversible cachexia;
* end-stage renal disease (dialysis);
* people already participating in a cardiac rehabilitation program at the time of enrollment;
* people with severe acquired brain injuries admitted for neurological rehabilitation.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Luisa E Luisi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione Don Carlo Gnocchi Onlus

Locations

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Fondazione Don Carlo Gnocchi

Florence, , Italy

Site Status

Countries

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Italy

References

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Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9.

Reference Type BACKGROUND
PMID: 25799486 (View on PubMed)

Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.

Reference Type BACKGROUND
PMID: 27642056 (View on PubMed)

Cereda E, Lucchin L, Pedrolli C, D'Amicis A, Gentile MG, Battistini NC, Fusco MA, Palmo A, Muscaritoli M. Nutritional care routines in Italy: results from the PIMAI (Project: Iatrogenic MAlnutrition in Italy) study. Eur J Clin Nutr. 2010 Aug;64(8):894-8. doi: 10.1038/ejcn.2010.85. Epub 2010 May 26.

Reference Type BACKGROUND
PMID: 20502467 (View on PubMed)

Lim SL, Ong KC, Chan YH, Loke WC, Ferguson M, Daniels L. Malnutrition and its impact on cost of hospitalization, length of stay, readmission and 3-year mortality. Clin Nutr. 2012 Jun;31(3):345-50. doi: 10.1016/j.clnu.2011.11.001. Epub 2011 Nov 26.

Reference Type BACKGROUND
PMID: 22122869 (View on PubMed)

Other Identifiers

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MalnutritionRehab_FDG

Identifier Type: -

Identifier Source: org_study_id

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