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

NCT06639100 | Active Not Recruiting

• 1 other identifier: REWINDER
• Study Type: observational
• Target: 63,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• PROMs

  The primary outcome measure will be pre-post change in the 3 PROMs that will be measured in the study population. All items will be condensed for the whole population into observations at baseline (time 0) and, 6 months and one year. Patient reported outcomes (PROMs) will be collected at baseline and after 6 12 months. All data will be linked to the administrative records to build an all-embracing file, which, after anonymization of the data, will be used for statistical analysis. A specific study questionnaire including all questions for the validated PROMs will be filled at the clinical site, with the direct support of a specialised care providers. The questionnaire will be administered twice, at baseline and follow-up visit (after 6 12 months).

  12 mouth

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Total population of 63,500 people with diabetes in 4 geographical areas of Emilia-Romagna.

You may qualify if:

• Eligible patients will be all those recorded in 4 operational units with an "active status", defined as those who attended a visit during the last three years or booked one in the course of the study.
• Participants will have T1D for at least 1 year and be aged ≥18 to \<40 years. Patients with type 2 diabetes will have diabetes for at least 1 year. PROMs will be measured among subjects aged ≥40 to \<70 years only.

You may not qualify if:

• Patients who deceased or migrated during the last three years prior to the start of the study.
• Furthermore, we will exclude pregnant women, patients with known and recorded cognitive deficiency (eg, Down's syndrome, Alzheimer), severe somatic comorbidity (eg, end-stage renal disease, severe heart failure, severe cancer), and/or a major psychiatric diagnosis (eg, severe depression or bipolar disorder, schizophrenia) as diabetes distress is often neither ethical nor possible to discuss with these groups of patients.

Sponsors & Collaborators

• AUSL Romagna Rimini: lead

Study Sites (1)

Ausl della Romagna Direttore UO di Diabetologia

Ravenna, RA, 48121, Italy

Location

Related Publications (1)

• Carinci F, Messina R, Michelini M, Bici A, Berardo A, Dei Cas A, Iezzi E, Di Iorio CT, Gualdi S, Aldigeri R, Fantini MP, Bonadonna RC, Massi Benedetti M, Di Bartolo P. Real-world data and patient-reported outcomes in diabetes in Emilia-Romagna (REWINDER): protocol of a federated cohort study for the regional evaluation of quality of care during and after COVID-19. BMJ Open. 2025 Oct 23;15(10):e102401. doi: 10.1136/bmjopen-2025-102401.

  PMID: 41130696 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: April 27, 2022
• Primary Completion: April 27, 2023
• Study Completion: October 26, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)