MultimorbiditiesSPIRNCT06872632
How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: A Multicenter Study
An observational study of Multimorbidities, run by Società Italiana di Medicina Interna at 21 sites in Italy.
Trial 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. Each enrolled participant will undergo a 12-month follow-up. The study foresees the enrollment of 2326 participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multimorbidities
- How many people
- 2,326 participants
- Where
- 21 sitesItaly
- Study dates
- 24 Jun 2024to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult hospitalized internal medicine patient
Who may be able to join
- age >= 18 years
- Informed consent according to Italian law.
Who cannot join
- No specific exclusion criteria were identified.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Italy21 sites, 21 recruiting
- Recruiting
AOU Policlinico di Bari - UO Medicina Interna
Bari, Italy, 70124
Angelo Vacca, MD PhD, +39 0805478057, angelo.vacca@uniba.it
- Recruiting
AOU Policlinico S. Orsola-Malpighi - UO Medicina interna, malattie epatobiliari e immunoallergologiche
Bologna, Italy, 40138
Fabio Piscaglia, MD PhD, +39 0512142542, fabio.piscaglia@unibo.it
- Recruiting
ASST degli Spedali Civili di Brescia - UO di Medicina Generale 2
Brescia, Italy, 25121
Maria Lorenza Muiesan, MD PhD, +39 0303998721, marialorenza.muiesan@unibs.it
- Recruiting
ASP di Catanzato - Presidio Ospedaliero "Giovanni Paolo II" di Lamezia Terme
Catanzaro, CZ, 88056
Gerardo Mancuso, MD PhD, +39 0961469557, gerardo.mancuso@asp.cz.it
- Recruiting
AOU "Dulbecco" di Catanzaro - Presidio Ospedaliero di Germaneto - UOC Geriatria
Catanzaro, CZ, 88100
Angela Sciacqua, MD PhD, +39 09613694103, sciacqua@unicz.it
- Recruiting
AOU Careggi - SOD Medicina Interna 4
Florence, FI, 50134
Alberto Moggi Pignone, MD PhD, +39 0552758020, alberto.moggipignone@unifi.it
- Recruiting
Ospedale Santa Maria Annunziata, Bagno a Ripoli - UOC di Medicina 1
Florence, Italy, 50012
Plinio Fabiani, MD, +39 0556810633, plinio.fabiani@gmail.com
- Recruiting
AOU Policlinico G. Martino - UOC Medicina Interna
Messina, ME, 98124
Giuseppe Mandraffino, MD PhD, gmandraffino@unime.it
- Recruiting
ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco - SC di Medicina Interna
Milan, Italy, 20157
Chiara Beatrice Cogliati, MD PhD, chiara.cogliati@unimi.it
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - UOC Medicina Interna - Alta Complessità Medica
Milan, MI, 20162
Alberto Benetti, MD, +39 02 6444.8164, alberto.benetti@ospedaleniguarda.it
- Recruiting
AOU Policlinico di Modena - UOC Medicina Interna
Modena, Italy, 44124
Elena Corradini, MD PhD, +39 0592055012, elena.corradini@unimore.it
- Recruiting
AOU Federico II di Napoli - UOC Medicina Interna ad indirizzo metabolico e riabilitativo
Naples, Italy, 80131
Antonio Cittadini, MD, +39 0817464375, antonio.cittadini@unina.it
- Recruiting
AOU Maggiore della Carità - UOC di Medicina Interna 1
Novara, Italy, 28100
Mario Pirisi, MD, +39 03213733361, mario.pirisi@med.uniupo.it
- Recruiting
Policlinico Universitario Campus Bio-Medico di Roma - UOC di Medicina Interna
Roma, Italy, 00128
Raffaele Antonelli Incalzi, MD, +39 06225411365, r.antonelli@policlinicocampus.it
- Recruiting
AOU Sant'Andrea - UOC di Medicina Interna
Roma, Italy, 00189
Alessandro Laviano, MD PhD, +39 0649973902, alessandro.laviano@uniroma1.it
- Recruiting
Fondazione Policlinico Universitario Tor Vergata - UOC Medicina Interna Centro Medico per l'Obesità
Roma, RM, 00133
Paolo Sbraccia, MD PhD, +39 0645250863, sbraccia@med.uniroma2.it
- Recruiting
AOU Policlinico Umberto I - UOC Medicina Interna e Nutrizione Clinica
Roma, RM, 00161
Maurizio Muscaritoli, MD PhD, +39 0649972016, m.muscaritoli@policlinicoumberto1.it
- Recruiting
IRCCS Ospedale San Raffaele - UO di Medicina Generale ad Indirizzo Specialistico e della Continuità Assistenziale
Roma, RM, 00163
Patrizia Rovere Querini, MD PhD, +39 0226431, rovere.patrizia@unisr.it
- Recruiting
ASST Lariana - Ospedale Sant'Anna di San Fermo della Battaglia - UOC Medicina Generale
San Fermo della Battaglia, CO, 22042
Alessandro Squizzato, MD PhD, +39 0315851, alessandro.squizzato@asst-lariana.it
- Recruiting
ASL 5 - Presidio Ospedaliero San Bartolomeo di Sarzana - UO di Clinica Medica Interna e Immunologia
Sarzana, SP, 19038
Giuseppe Murdaca, MD PhD, +39 0187533915, giuseppe.murdaca@unige.it
- Recruiting
ASST Sette Laghi - Ospedale di Circolo di Varese
Varese, VA, 21100
Marco Paolo Donadini, MD PhD, +39 0332 278111, marcopaolo.donadini@asst-settelaghi.it
About this study
Official title: EFFECTS OF COMPLEXITY AND MULTIMORBIDITY ON CLINICAL OUTCOMES IN HOSPITALIZED INTERNAL MEDICINE PATIENTS
The goal of this observational study is to evaluate the association between complexity and multiple illnesses of adult hospitalized internal medicine patient and mortality. Each enrolled participant will undergo a 12-month follow-up.
The study foresees the enrollment of 2326 participants.
Read the detailed description
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.
- Conditions
- Multimorbidities
- Keywords
- mortality, internal medicine, Mulimorbidities
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between clinical complexity/multimorbidity and mortality
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.
Measured: 12 months
Secondary outcomes (1)
Correlation between pre-existing factors at hospitalization and clinical outcomes
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 Association between disease severity parameters (e.g. biohumoral, score, etc.) and clinical outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start24 Jun 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbiditiesStudies of the same condition, open and under way.
- 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
- 2,326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Società Italiana di Medicina Interna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872632
- Sponsor's protocol ID
- SPIR
- Acronym
- SPIR
- Status last verified
- Oct 2026
- First submitted
- 25 Feb 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF COMPLEXITY AND MULTIMORBIDITY ON CLINICAL OUTCOMES IN HOSPITALIZED INTERNAL MEDICINE PATIENTS
- ClinicalTrials.gov ID
- NCT06872632
- Acronym / sponsor ID
- SPIR / SPIR
- Conditions
- Multimorbidities
- Keywords
- mortality, internal medicine, Mulimorbidities
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,326 participants (estimated)
- Lead sponsor
- Società Italiana di Medicina InternaUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 12 Mar 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 evaluate the association between complexity and multiple illnesses of adult hospitalized internal medicine patient and mortality. Each enrolled participant will undergo a 12-month follow-up.
The study foresees the enrollment of 2326 participants.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized internal medicine patient
Key inclusion criteria (2 listed)
- age >= 18 years
- Informed consent according to Italian law.
Key exclusion criteria (1 listed)
- No specific exclusion criteria were identified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between clinical complexity/multimorbidity and mortality
Time frame: 12 months
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.
1 secondary outcome
Correlation between pre-existing factors at hospitalization and clinical outcomes
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidities, run by Società Italiana di Medicina Interna at 21 sites 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 1 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriana Arengi (+39 0644340373, cris@simi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between clinical complexity/multimorbidity and mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.