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RecruitingNCT06872632Updated Mar 12, 2025

How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: a Multicenter Study

An observational study in Complexity and Multiple Illnesses of Adult Hospitalized Internal Medicine Patient, sponsored by Società Italiana di Medicina Interna. Recruiting at 12 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by Società Italiana di Medicina Interna · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,326
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to evaluate the association between complexity and multiple illnesses of adult hospitalized internal medicine patient and mortality. The observational study will also evaluate the association between pre-existing factors at hospitalization and clinical outcomes such as mortality, length of hospital stay, intensity of care (transfer to units with higher clinical intensity), complications and rehospitalization.

For data collection, four index weeks will be identified during the year in which the participating Centers will have to sequentially enroll all the participants who will be admitted to the Internal Medicine units, until reaching, for each index week, 10 participants for each of the Participating Centers.

Each enrolled participant will undergo a 12-month follow-up. The study foresees the enrollment of 2326 participants.

02

Conditions studied

  • Complexity and Multiple Illnesses of Adult Hospitalized Internal Medicine Patient
03

In context

Lead sponsor

This is the only study on the registry with Società Italiana di Medicina Interna as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult hospitalized internal medicine patient

Inclusion criteria

  1. Patients of legal age (age >= 18 years).
  2. Informed consent according to Italian law.

Exclusion criteria

Exclusion Criteria:

  • No specific exclusion criteria were identified.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,326 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. to evaluate the correlation between clinical complexity/multimorbidity of the hospitalized internal medicine patient, defined by the Cumulative Illness Rating Scale (CIRS), and mortality.

    to evaluate the correlation between clinical complexity/multimorbidity of the hospitalized internal medicine patient, defined by the Cumulative Illness Rating Scale (CIRS), and mortality. Cumulative Illness Rating Scale: severity index (minimum value is 1, maximum value is 5), comorbidity index (minimum value is 0, maximum value is 13). Higher scores mean worse outcome.

    Time frame: 12 months

Secondary outcomes

  1. to evaluate the correlation between pre-existing factors at hospitalization and clinical outcomes - to evaluate the association between disease severity parameters and clinical outcomes

    * to evaluate the correlation between pre-existing factors at hospitalization, such as polypharmacy, age, prevalent chronic diseases (e.g. heart failure, respiratory failure and pneumonia, decompensated diabetes, etc.) and clinical outcomes such as mortality, length of hospital stay, intensity of care (transfer to units with higher clinical intensity), complications and rehospitalization * to evaluate the association between disease severity parameters (e.g. biohumoral, score, etc.) and clinical outcomes.

    Time frame: 12 months

07

Study locations

12 of 12 sites recruiting
  • AOU Policlinico di Bari- Unità Operativa di Medicina Interna "Guido Baccelli
    Bari, 70124, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola - Malpighi- UO Medicina interna, malattie epatobiliari e immunoallergologiche
    Bologna, 40138, Italy
    Recruiting
  • ASST degli Spedali Civili di Brescia- Medicina Generale 2
    Brescia, 25121, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria S. Anna di Ferrara- Clinica Medica
    Ferrara, 44124, Italy
    Recruiting
  • Ospedale Santa Maria Annunziata, Bagno a Ripoli, Firenze- Medicina 1
    Firenze, 50012, Italy
    Recruiting
  • AOU G. Martino- UOC Medicina Interna
    Messina, 98124, Italy
    Recruiting
  • ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco- Struttura Complessa di Medicina Interna
    Milano, 20157, Italy
    Recruiting
  • AOU Modena - Policlinico di Modena - S.C. Medicina Interna
    Modena, 44124, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria Federico II, Napoli- UOC Medicina Interna ad indirizzo metabolico e riabilitativo
    Napoli, 80131, Italy
    Recruiting
  • Ospedale Maggiore della Carità di Novara- SCDU Medicina Interna 1, AOU Maggiore della Carità
    Novara, 28100, Italy
    Recruiting
  • Policlinico Universitario Campus Bio-Medico di Roma- UOC Medicina Interna
    Roma, 00128, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria Sant'Andrea- UOC Medicina Interna
    Roma, 00189, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06872632
Lead sponsor
Società Italiana di Medicina Interna
Responsible party
Sponsor
First posted
Mar 12, 2025
Start date
Jun 24, 2024
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Mar 12, 2025

Study contacts

Nicola Montano, MD PhD
Contact
nicola.montano@simi.it
0039 064434037

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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