NCT06872632

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,326

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jun 2024Jun 2028

Study Start

First participant enrolled

June 24, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.9 years

First QC Date

February 25, 2025

Last Update Submit

March 10, 2025

Conditions

Complexity and Multiple Illnesses of Adult Hospitalized Internal Medicine Patient

Outcome Measures

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.

    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

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult hospitalized internal medicine patient

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

AOU Policlinico di Bari- Unità Operativa di Medicina Interna "Guido Baccelli

Bari, Italy, 70124, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola - Malpighi- UO Medicina interna, malattie epatobiliari e immunoallergologiche

Bologna, Italy, 40138, Italy

RECRUITING

ASST degli Spedali Civili di Brescia- Medicina Generale 2

Brescia, Italy, 25121, Italy

RECRUITING

Azienda Ospedaliero-Universitaria S. Anna di Ferrara- Clinica Medica

Ferrara, Italy, 44124, Italy

RECRUITING

Ospedale Santa Maria Annunziata, Bagno a Ripoli, Firenze- Medicina 1

Florence, Italy, 50012, Italy

RECRUITING

AOU G. Martino- UOC Medicina Interna

Messina, Italy, 98124, Italy

RECRUITING

ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco- Struttura Complessa di Medicina Interna

Milan, Italy, 20157, Italy

RECRUITING

AOU Modena - Policlinico di Modena - S.C. Medicina Interna

Modena, Italy, 44124, Italy

RECRUITING

Azienda Ospedaliera Universitaria Federico II, Napoli- UOC Medicina Interna ad indirizzo metabolico e riabilitativo

Napoli, Italy, 80131, Italy

RECRUITING

Ospedale Maggiore della Carità di Novara- SCDU Medicina Interna 1, AOU Maggiore della Carità

Novara, Italy, 28100, Italy

RECRUITING

Policlinico Universitario Campus Bio-Medico di Roma- UOC Medicina Interna

Roma, Italy, 00128, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea- UOC Medicina Interna

Roma, Italy, 00189, Italy

RECRUITING

Central Study Contacts

Nicola Montano, MD PhD

CONTACT

0039 064434037nicola.montano@simi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 12, 2025

Study Start

June 24, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

IT(12)