NCT06639100

This Will Be an Observational, Exploratory Study Targeting a Population of Subjects with Diabetes from 4 Different Geographical Areas of Emilia- Romagna.

Real World Data and Patient Reported Outcomes in Diabetes: a Standard Set for Person-Centred Care in Emilia-Romagna During and After Covid-19

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 63,500 (estimated)
• Sponsor: AUSL Romagna Rimini · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This will be an observational, exploratory study targeting a population of subjects with diabetes from 4 different geographical areas of Emilia- Romagna.

Detailed description

Diabetes is a pivot condition involving a range of complications and interventions from multiple care providers over a long period of time. For this reason, it represents a critical field of chronic care where person-centred models can be better implemented using real world data on a continuous basis to support research and clinical practice. These activities are extremely challenging to carry out at national level, due to the lack of standardised definitions and clear guidelines on privacy and data protection, data exchange and statistical processing. We propose to implement a Regional Surveillance System for person-centred care in Diabetes that will be sustainable, standardised, actionable, introducing a value-based approach, privacy enhanced, statistically fair (internationally comparable), and clinically transparent, whose performance outputs will be made publicly available. This will be an observational, exploratory study targeting a population of subjects with diabetes from 4 different geographical areas of Emilia- Romagna. The study population will be followed up by 4 participating centres for 612 months, which already collect demographics, anthropometric data and clinical records at the Diabetes Outpatient Clinics using the same electronic format and data management software (Smart Digital Clinic from Meteda). Measurements for the target population will be available on a rolling basis, as they will be recorded as a part of routine care during ordinary visits. Further information will be acquired using other administrative sources, through data linkage of available databases: hospital discharge records, pharmaceutical prescriptions in and out of hospital, specialist visits, payment exemption and the primary master index (mortality records).The project will enroll all patients from 4 operational units (Romagna, Ferrara, Reggio Emilia and Parma). The UO "Diabetology" at "Azienda USL della Romagna" has a capacity of a total patient pool of 28,000 consecutive patients per year. The UO "Diabetology" at Azienda USL Reggio Emilia has a capacity of a total patient pool of 40,000 consecutive patients per year. The UO "Endocrinologia e Malattie del Metabolismo" at Azienda Ospedaliero- Universitaria Parma has a capacity of a total patient pool of 2,500 consecutive patients per year. The UO "Diabetology" at Azienda USL Ferrara has a capacity of a total patient pool of 5,000 consecutive patients per year. All centres collect personal data, anthropometric and clinical records of the Diabetes Outpatient Clinic using the same electronic format and data management software (Smart Digital Clinic from Meteda). Therefore, measurements for the target population will be available on a continuous basis, as they will be recorded as a part of routine care during ordinary visits. This basis will be used to select 1,600 consecutive patients that will be followed up expanding the range of items available through a specific activity of data collection in the areas of PROMs and Covid-19. Each operating unit will recruit 400 patients (\~100 with type 1 diabetes and \~300 with type 2 diabetes).

Conditions

• Diabetes Mellitus

Timeline

• Start date: 2022-04-27
• Primary completion: 2023-04-27
• Completion: 2024-10-26
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: Italy