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Completed

NCT Number: NCT07183098

Prevalence and Clinical-Economic Aspects of Malnutrition in Rehabilitation

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.

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Key information

Conditions

Rehabilitation Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Don Carlo Gnocchi

Florence, 50143, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Participiants at high risk of malnutrition who received standard nutritional care

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

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

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.

Primary outcomes

  1. Hospital readmissions rate

    Time frame: 90 days post discharge

    The rate of hospital readmissions at three months post-discharge was computed as number of hospital readmissions from discharge to three-month follow-up.

Secondary outcomes

  1. Emergency department admissions rate

    Time frame: 90 days post-discharge

    The rate of emergency department admissions was computed as the number of emergency department admissions from discharge to three-month follow-up.

  2. General practitioner visits rate

    Time frame: 90 days post-discharge

    General practitioner visits rate was computed as the number of general practitioner visits from discharge to three-month follow-up

  3. Outpatient visits rate

    Time frame: 90 days post-discharge

    The outpatient visits rate was computed as the number of outpatient visits from discharge to three-month follow-up

  4. Diagnostic tests rate

    Time frame: 90 days post-discharge

    The diagnostic tests rate was computed as the number of diagnostic tests performed from discharge to three-month follow-up

  5. Daily medication rate

    Time frame: 90 days post-discharge

    Daily medication rate is the number of drugs/day computed from discharge to three-month follow-up

  6. Mortality rate

    Time frame: 90 days post-discharge

    Mortality rate was computed as the number of participiants dead from discharge to three-month follow-up

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

A Prospective Observational Study on the Prevalence of Malnutrition and Clinical-Economic Aspects of the Impact of Specialized Nutritional Care on the 3-month Outcomes of Patients at High Risk of Malnutrition Admitted to a Rehabilitation Hospital

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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