MED-Cli: Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Recruiting

CT.gov ID

NCT05780099

Collaborator

(none)

50,000

Enrollment

Locations

122.6

Anticipated Duration (Months)

25000

Patients Per Site

204

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients referred to internal medicine wards are becoming increasingly complex and fragile. Despite deep knowledge of their specific disorders, steps are required to improve overall management of their acute and chronic conditions. The main objective of the study is to identify demographic, clinical, laboratory and radiological markers of disease severity and activity in patients with diseases treated at general medicine wards (respiratory disease, immune-mediated disease, sepsis, metabolic disease, rare disease, frailty, pregnancy pathology) in order to improve their diagnosis, monitoring and treatment processes.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Disease Cardiovascular Diseases Infectious Disease Critical Illness Immunological Disease Pregnancy Disease Metabolic Syndrome Chronic Disease	Other: Inpatient or Outpatient visit

Study Design

Study Type:

Observational

Anticipated Enrollment :

50000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

Actual Study Start Date :

Jun 24, 2022

Anticipated Primary Completion Date :

Sep 10, 2031

Anticipated Study Completion Date :

Sep 10, 2032

Arms and Interventions

Arm	Intervention/Treatment
Cases patients treated at internal medicine wards	Other: Inpatient or Outpatient visit Patients will be seen and treated at the clinics like in the usual care

Arm

Intervention/Treatment

Cases

patients treated at internal medicine wards

Other: Inpatient or Outpatient visit

Patients will be seen and treated at the clinics like in the usual care

Outcome Measures

Primary Outcome Measures

Number of participants with severe disease [The following variables will be collected during patient enrollment]
Identify demographic, clinical, laboratory and radiological markers of disease severity and activity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Receving treatment at internal medicine departments (inpatient, outopatient, day hospital) of San Raffaele Hospital
at least one suspected or confirmed diagnosis among:

immune mediated disorder
respiratory disorder
metabolic disorder
sepsis
rare disorder (according to Italian Ministry of Health list)
pregnancy-related disorder
frailty defined as: either ≥2 CIRS (Cumulative Illness Rating Scale) Severity Index 10 or ≤70% Karnofsky scale