Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-28 @ 2:06 AM
Study NCT ID:
NCT06872632
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2025-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: a Multicenter Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2326}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the correlation between clinical complexity/multimorbidity of the hospitalized internal medicine patient, defined by the Cumulative Illness Rating Scale (CIRS), and mortality.', 'timeFrame': '12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'to evaluate the correlation between pre-existing factors at hospitalization and clinical outcomes - to evaluate the association between disease severity parameters and clinical outcomes', 'timeFrame': '12 months', 'description': '* 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\n* to evaluate the association between disease severity parameters (e.g. biohumoral, score, etc.) and clinical outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complexity and Multiple Illnesses of Adult Hospitalized Internal Medicine Patient']}, 'descriptionModule': {'briefSummary': '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.\n\nFor 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.\n\nEach enrolled participant will undergo a 12-month follow-up. The study foresees the enrollment of 2326 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult hospitalized internal medicine patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of legal age (age \\>= 18 years).\n2. Informed consent according to Italian law.\n\nExclusion Criteria:\n\n* No specific exclusion criteria were identified.'}, 'identificationModule': {'nctId': 'NCT06872632', 'briefTitle': "How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: a Multicenter Study", 'organization': {'class': 'OTHER', 'fullName': 'Società Italiana di Medicina Interna'}, 'officialTitle': 'EFFETTI DELLA COMPLESSITÀ E MULTIMORBIDITÀ SUGLI ESITI CLINICI NEL PAZIENTE INTERNISTICO OSPEDALIZZATO: STUDIO MULTICENTRICO, OSSERVAZIONALE E PROSPETTICO - EFFECTS of COMPLEXITY and MULTIMORBIDITY on CLINICAL OUTCOMES in HOSPITALIZED INTERNAL MEDICINE PATIENTS: a MULTICENTER, OBSERVATIONAL and PROSPECTIVE STUDY', 'orgStudyIdInfo': {'id': '207/2023/OSS/AOUMO'}}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angelo Vacca, MD PhD', 'role': 'CONTACT', 'email': 'angelo.vacca@uniba.it', 'phone': '00390805478057'}], 'facility': 'AOU Policlinico di Bari- Unità Operativa di Medicina Interna "Guido Baccelli', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40138', 'city': 'Bologna', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Fabio Piscaglia, MD PhD', 'role': 'CONTACT', 'email': 'fabio.piscaglia@unibo.it', 'phone': '0039390512142542'}], 'facility': 'Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola - Malpighi- UO Medicina interna, malattie epatobiliari e immunoallergologiche', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '25121', 'city': 'Brescia', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Lorenza Muiesan, MD', 'role': 'CONTACT', 'email': 'marialorenza.muiesan@unibs.it', 'phone': '00390303998721'}], 'facility': 'ASST degli Spedali Civili di Brescia- Medicina Generale 2', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '44124', 'city': 'Ferrara', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Manfredini, MD PhD', 'role': 'CONTACT', 'email': 'roberto.manfredini@unife.it', 'phone': '00390532237166'}], 'facility': 'Azienda Ospedaliero-Universitaria S. Anna di Ferrara- Clinica Medica', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '50012', 'city': 'Florence', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Plinio Fabiani, MD', 'role': 'CONTACT', 'email': 'plinio.fabiani@gmail.com', 'phone': '00390556810633'}], 'facility': 'Ospedale Santa Maria Annunziata, Bagno a Ripoli, Firenze- Medicina 1', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '98124', 'city': 'Messina', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Squadrito, MD PhD', 'role': 'CONTACT', 'email': 'gsquadrito@unime.it', 'phone': '00390902212359'}], 'facility': 'AOU G. Martino- UOC Medicina Interna', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20157', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Beatrice Cogliati', 'role': 'CONTACT', 'email': 'chiara.cogliati@unimi.it'}], 'facility': 'ASST Fatebenefratelli Sacco, Ospedale Luigi Sacco- Struttura Complessa di Medicina Interna', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '44124', 'city': 'Modena', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonello Pietrangelo, MD PhD', 'role': 'CONTACT', 'email': 'pietra@unimore.it', 'phone': '00390594222714'}], 'facility': 'AOU Modena - Policlinico di Modena - S.C. Medicina Interna', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '80131', 'city': 'Napoli', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Cittadini, MD', 'role': 'CONTACT', 'email': 'antonio.cittadini@unina.it', 'phone': '00390817464375'}], 'facility': 'Azienda Ospedaliera Universitaria Federico II, Napoli- UOC Medicina Interna ad indirizzo metabolico e riabilitativo', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '28100', 'city': 'Novara', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Pirisi, MD', 'role': 'CONTACT', 'email': 'mario.pirisi@med.uniupo.it', 'phone': '003903213733361'}], 'facility': 'Ospedale Maggiore della Carità di Novara- SCDU Medicina Interna 1, AOU Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '00128', 'city': 'Roma', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaele Antonelli Incalzi, MD', 'role': 'CONTACT', 'email': 'r.antonelli@policlinicocampus.it', 'phone': '003906225411365'}], 'facility': 'Policlinico Universitario Campus Bio-Medico di Roma- UOC Medicina Interna', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00189', 'city': 'Roma', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Laviano, MD PhD', 'role': 'CONTACT', 'email': 'alessandro.laviano@uniroma1.it', 'phone': '00390649973902'}], 'facility': "Azienda Ospedaliero-Universitaria Sant'Andrea- UOC Medicina Interna", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Nicola Montano, MD PhD', 'role': 'CONTACT', 'email': 'nicola.montano@simi.it', 'phone': '0039 064434037'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Società Italiana di Medicina Interna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}