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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-50
SponsorMarche Region Regional Health Agency

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Failure to meet the inclusion criteria

Lack of written informed consent.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Screening program

    Other intervention

    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).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

To assess the screening adherence through coverage

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

Time frame
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

1

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

This outcome will be assessed evaluating the scores derived from FINDRISC tool, along with Glycated Hemoglobin (HbA1c), to determine risk of developing diabetes. FINDRISC uses: * age (score=2 for people aged 50 years) * vegetable \& fruit intake (every day=0; otherwise= 1) * history of hyperglycemia (no=0; yes=5; ) * Body Mass Index (BMI) (kg/m\^2) (from 0 to 3, as increases) * physical activity (yes=0; no=2) * medical treatment of hypertension (yes=2; no=1) * family history of diabetes (no=0; otherwise, up to 5) * waist circumference (cm) (from 0 to 4, as increases) The detection of the HbA1c will be conducted for the moderate, high and very high-risk levels, to accurately complete the risk assessment for results \>9, a cut-off level suggestive of further investigation, as per literature. Based on the final score, ranging from 0 to 26, four risk levels are defined: I- Low risk (≤9); II- Moderate risk (\>9≤15 score); III: High risk (\>15 ≤20 score); IV- Very high risk (\> 20 score).

Time frame
This outcome will be evaluated when participants will conduct the screening evaluation (T0), when the risk score will be computed.
2

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

This outcome will be assessed evaluating the scores derived from CUORE tool, representing the probability of experiencing a first major cardiovascular event (myocardial infarction or stroke) in the next 10 years, based on 8 risk factors: gender, age, diabetes, smoking habit, systolic blood pressure (mmHg), total cholesterolaemia (mg/dl), High-Density Lipoprotein-cholesterolaemia (mg/dl) and anti-hypertensive treatment. The individual score is computed by the formula: 1 - \[S(t)\] \^ {EXP \[β1 × age + β2 × PAS + β3 × COL + β4 × HDL + β5 (if SMOKER) + β6 (if DIABETIC) + β7 (if TREATED with antihypertensives) - G(µ)\]}; S(t)=10-year survival evaluated at the mean value of the factors; βi= the coefficients of the risk factors; G(µ)= linear combination of the factor averages or prevalence in each cathegory by the respective coefficients βi. Based on the final score (from 0% to 100%), 3 risk levels are identified: I- Low risk: \<3%; II- Moderate risk: ≥3-\<20%; III: High risk: ≥20%.

Time frame
This outcome will be evaluated when participants will conduct the screening evaluation (T0), when the risk score will be computed.
3

To determine the Diabetes Mellitus Type 2 risk detection rate

This outcome will be assessed evaluating the proportion of persons with unrecognized risk of developing Diabetes Mellitus Type 2, by using the final scores from the FINDRISC tool, along with Glycated Hemoglobin, when foreseen. This detection rate is calculated as the proportion of individuals identified as having moderate, high, or very high risk of developing diabetes over the next decade, based on the FINDRISC scores.

Time frame
This outcome will be evaluated when participants will conduct the screening evaluation (T0), when the risk score will be computed.
4

To determine the Cardiovascular Diseases' risk detection rate

This outcome will be assessed evaluating the proportion of persons with unrecognized risk of developing a major Cardiovascula Diseases, by using the final scores from the CUORE tool, which predicts the probability of experiencing a first major cardiovascular event (such as myocardial infarction or stroke) within the next 10 years This detection rate is calculated as the proportion of individuals identified as having moderate, high, or very high risk of developing cardiovascular disease over the next decade, based on the CUORE score.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marche Region Regional Health Agency

Lead sponsor

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