RehabilitationNCT07183098
Prevalence and Clinical-Economic Aspects of Malnutrition in Rehabilitation
An observational study of Rehabilitation and Malnutrition, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rehabilitation, Malnutrition
- What is being tested?
- Participiants at high risk of malnutrition who received standard nutritional care, Participiants at high risk of malnutrition who received specialized nutritional care and 3 month-post discharge evaluation
- How many people
- 193 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2018to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A consecutive series of people at high risk of malnutrition (Malnutrition Universal Screening Tool-MUST equal or higher than 2) admitted to the rehabilitation wards of the IRCCS Fondazione Don Carlo Gnocchi ONLUS.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Rehabilitation, Malnutrition
- Being tested
- Participiants at high risk of malnutrition who received standard nutritional care, Participiants at high risk of malnutrition who received specialized nutritional care, 3 month-post discharge evaluation
- Keywords
- Rehabilitation, Dietitians, Healthcare costs, MUST-Malnutrition Universal Screening Tool, malnutrition, Nutritional care
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participiants at high risk of malnutrition who received standard nutritional careOther
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 careOther
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 evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Participiants at high risk of malnutrition who received standard nutritional care; Other: Participiants at high risk of malnutrition who received specialized nutritional care; Other: 3 month-post discharge evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmissions rate
The rate of hospital readmissions at three months post-discharge was computed as number of hospital readmissions from discharge to three-month follow-up.
Measured: 90 days post discharge
Secondary outcomes (6)
Emergency department admissions rate
The rate of emergency department admissions was computed as the number of emergency department admissions from discharge to three-month follow-up.
Measured: 90 days post-discharge
General practitioner visits rate
General practitioner visits rate was computed as the number of general practitioner visits from discharge to three-month follow-up
Measured: 90 days post-discharge
Outpatient visits rate
The outpatient visits rate was computed as the number of outpatient visits from discharge to three-month follow-up
Measured: 90 days post-discharge
Diagnostic tests rate
The diagnostic tests rate was computed as the number of diagnostic tests performed from discharge to three-month follow-up
Measured: 90 days post-discharge
Daily medication rate
Daily medication rate is the number of drugs/day computed from discharge to three-month follow-up
Measured: 90 days post-discharge
Mortality rate
Mortality rate was computed as the number of participiants dead from discharge to three-month follow-up
Measured: 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start15 Apr 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Luisa E Luisi, MD, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183098
- Sponsor's protocol ID
- MalnutritionRehab_FDG
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25799486Cederholm 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.
PubMed 27642056Cereda 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.
PubMed 20502467Lim 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.
PubMed 22122869
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07183098
- Acronym / sponsor ID
- MalnutritionRehab_FDG
- Conditions
- Rehabilitation, Malnutrition
- Keywords
- Rehabilitation, Dietitians, Healthcare costs, MUST-Malnutrition Universal Screening Tool, malnutrition, Nutritional care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participiants at high risk of malnutrition admitted to a rehabilitation hospital | – | Other: Participiants at high risk of malnutrition who received standard nutritional care, Other: Participiants at high risk of malnutrition who received specialized nutritional care, Other: 3 month-post discharge evaluationParticipiants at high risk of malnutrition who received standard nutritional care were compared with participiants at high risk of malnutrition who received specialized nutritional care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A consecutive series of people at high risk of malnutrition (Malnutrition Universal Screening Tool-MUST equal or higher than 2) admitted to the rehabilitation wards of the IRCCS Fondazione Don Carlo Gnocchi ONLUS.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participiants at high risk of malnutrition who received standard nutritional careThe 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. | Other | Participiants at high risk of malnutrition admitted to a rehabilitation hospital |
| Participiants at high risk of malnutrition who received specialized nutritional carePeople 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. | Other | Participiants at high risk of malnutrition admitted to a rehabilitation hospital |
| 3 month-post discharge evaluationThree 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. | Other | Participiants at high risk of malnutrition admitted to a rehabilitation hospital |
Primary outcome
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.
6 secondary outcomes
Emergency department admissions rate
Time frame: 90 days post-discharge
General practitioner visits rate
Time frame: 90 days post-discharge
Outpatient visits rate
Time frame: 90 days post-discharge
Diagnostic tests rate
Time frame: 90 days post-discharge
Daily medication rate
Time frame: 90 days post-discharge
Mortality rate
Time frame: 90 days post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 25799486Cederholm 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.
- Background: PubMed 27642056Cederholm 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.
- Background: PubMed 20502467Cereda 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.
- Background: PubMed 22122869Lim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Luisa E Luisi, MD principal investigator
IRCCS Fondazione Don Carlo Gnocchi ONLUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation and Malnutrition, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmissions rate (time frame: 90 days post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183098, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.