Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639100
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
This Will Be an Observational Exploratory Study Targeting a Population of Subjects with Diabetes from 4 Different Geographical Areas of Emilia- Romagna
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REWINDER
Brief 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 recordsThe 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 28000 consecutive patients per year The UO Diabetology at Azienda USL Reggio Emilia has a capacity of a total patient pool of 40000 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 2500 consecutive patients per year The UO Diabetology at Azienda USL Ferrara has a capacity of a total patient pool of 5000 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 1600 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
This basis will be used to select 1600 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None