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

NCT07344701 | Not Yet Recruiting

• 1 other identifier: 4253
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Diseases; Diabetes Mellitus Type 2

Keywords

Diagnostic Screening Program; Delivering of healthcare, integrated; risk factors; Diabetes Mellitus Type 2; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• To assess the screening adherence through coverage

  This outcome will be assessed computing the percentage (%) of screening participants against invited

  This outcome will be evaluated at the end of the study (end of the year 2026), when all the eligible persons will be invited and will have had the possibility to conduct the screening evaluation

Secondary Outcomes (6)

• To evaluate the 10-years risk of developing Type 2 Diabetes event for each person

  This outcome will be evaluated when participants will conduct the screening evaluation (T0), when the risk score will be computed.

• To evaluate the 10-years risk of developing a major Cardiovascular risk event for each person

  This outcome will be evaluated when participants will conduct the screening evaluation (T0), when the risk score will be computed.

• To determine the Diabetes Mellitus Type 2 risk detection rate

  This outcome will be evaluated when participants will conduct the screening evaluation (T0), when the risk score will be computed.

• To determine the Cardiovascular Diseases' risk detection rate

  This outcome will be evaluated when participants will conduct the screening evaluation (T0), when the risk score will be computed.

• To compute the % of individuals adhering to the suggested pathway (e.g., visit to the General practitioners, or to the lifestyle counselling), according to the risk level.

  This outcome will be evaluated at T1 and T2 (3 and 6 months respectively from the screening evaluation). Participants will be contacted in T1; if they T1 did not answer or answered not to have follow the pathway, will be contacted at T2.

Interventions

Screening program OTHER

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).

Eligibility Criteria

• Age: 50 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target population will be composed by the residents of Ascoli Piceno province (one of the inclusion criteria)

You may qualify if:

• Citizens resident in Ascoli Piceno province
• People turning 50 in 2026
• Capacity to consent
• Fulfilling and signing the informed consent related to the participation to the study.

You may not qualify if:

• a concomitant diagnosis of DM and a previous CVD major event (one or more between Myocardial infarction, Haemorrhagic and/or ischaemic stroke, Revascularization interventions, as percutaneous coronary intervention/coronary artery bypass graft)
• Lack of written informed consent.

Sponsors & Collaborators

• Marche Region Regional Health Agency: lead
• REGIONAL HEALTH UNIT - MARCHE REGION - AREA 5 (ASUR Marche, Area Vasta 5, Distretto Sanitario San Benedetto), Italy: collaborator
• Azienda Sanitaria Locale USL 13 Ospedale Mazzoni di Ascoli Piceno: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2

Interventions

Diagnostic Screening Programs

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Claudio CA Angelini

  Local Health Authority of Ascoli Piceno

  PRINCIPAL INVESTIGATOR

• Roberta RP Papa

  Regional Health Agency of Marche Region

  STUDY DIRECTOR

• Giulia GF Franceschini

  Regional Health Agency of Marche Region

  STUDY DIRECTOR

Central Study Contacts

Claudio CA Angelini

CONTACT

+39 0736-358016; claudio.angelini@sanita.marche.it

Aurora AL Luciani

CONTACT

aurora.luciani@sanita.marche.it

Study Design

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

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP