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NOT YET RECRUITING
NCT07344701

"Screening for Change: Early Risk Detection and Integrated Prevention for Diabetes and Cardiovascular Diseases in the Marche Region"

Sponsor: Marche Region Regional Health Agency

View on ClinicalTrials.gov

Summary

This study aims to test the feasibility of a new systematic screening program to allow the early detection of individuals aged 50 years at risk of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVDs) in the resident in the province of Ascoli Piceno and without previous diagnosis, using the CUORE and FINDRISDC tools developed in the Project. The intervention will be conducted at the premises of the Prevention Department in Ascoli Piceno and San Benedetto del Tronto, within the Local Health Authority of Ascoli Piceno (Marche Region, Italy), throughout 2026. Eligible individuals will be invited, based on recruitment criteria, to the screening via a letter containing study information and participation instructions. Those willing to participate will book the appointment to undergo the screening in one of the two premises of the Prevention Department involved in the study (namely, San Benedetto del Tronto and Ascoli Piceno), through the regional reservation system (CUP). On the scheduled date, participants will visit the Prevention Department, where healthcare professionals (HCPs) will explain the study, obtain the informed consent, and collect data related to the CUORE and/or FINDRISC questionnaires, as well as sociodemographic information. The calculated scores will determine the 10-year risks of T2DM and major CVD events. Based on these risks, participants will be provided with tailored suggested pathways. A summary letter outlining these pathways will be delivered, and, in case of consent, results will be added to the participants' Electronic Health Record. Follow-up calls will be scheduled at 3 (T1) and 6 (T2) months to assess adherence to the suggested pathway (e.g., visit the General Practitioner (GP), lifestyle counselling) through a phone call.

Official title: Early Risk Detection of Type 2 Diabetes and Cardiovascular Diseases: an Italian Cohort Study

Key Details

Gender

All

Age Range

50 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2026-01

Completion Date

2026-12-31

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

OTHER

Screening program

The intervention will consist in a systematic screening of the participants to identify people at risk of developing T2DM (FINDRISC questionnaire) and CVDs (CUORE questionnaire, along with HbA1c).