[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Marche Region Regional Health Agency\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":75},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100619444","screening-for-change-early-risk-detection-and-integrated-prevention-for-diabetes-and-cardiovascular-diseases-in-the-marche-region-100619444",false,"NCT07344701","\"Screening for Change: Early Risk Detection and Integrated Prevention for Diabetes and Cardiovascular Diseases in the Marche Region\"","Early Risk Detection of Type 2 Diabetes and Cardiovascular Diseases: an Italian Cohort Study","JAC_AST","Inclusion Criteria:\n\n* Citizens resident in Ascoli Piceno province\n* People turning 50 in 2026\n* Capacity to consent\n* Fulfilling and signing the informed consent related to the participation to the study.\n\nExclusion Criteria:\n\n* a concomitant diagnosis of DM and a previous CVD major event (one or more between Myocardial infarction, Haemorrhagic and\u002For ischaemic stroke, Revascularization interventions, as percutaneous coronary intervention\u002Fcoronary artery bypass graft)\n* Failure to meet the inclusion criteria\n* Lack of written informed consent.","ALL","50 Years",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nEligible 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\u002For 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.",[25,26],"Cardiovascular Diseases","Diabetes Mellitus Type 2",[28,29,30,26,25],"Diagnostic Screening Program","Delivering of healthcare, integrated","risk factors","NOT_YET_RECRUITING","2026-01-15",{"date":34,"type":35},"2026-01-20","ACTUAL",{"date":37,"type":21},"2026-01",{"date":39,"type":21},"2026-12-31",{"name":41,"class":42},"Marche Region Regional Health Agency","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":73,"locationsCount":74},"100604445","connected-care-for-type-2-diabetes-self-management-100604445","NCT07149610","Connected Care for Type 2 Diabetes Self-Management","Connected Care for Type 2 Diabetes: a Study Protocol for a Structured Self-Management Intervention Through Technology and Healthcare Collaboration","RCT_SM","Inclusion Criteria:\n\n* patients with T2DM (as confirmed by the physician's diagnosis);\n* belonging to one of the 13 Diabetes Centres (CADs) of the Marche region in Italy (Pesaro, Urbino, Fano, Senigallia, Jesi, Fabriano, IRCCS-INRCA, Azienda Ospedaliera Universitaria delle Marche, Civitanova Marche, Macerata, Fermo, San Benedetto del Tronto e Ascoli Piceno);\n* age \\> = 18;\n* resident in the Marche region;\n* HbA1c \\> 7 on most recent laboratory report within the last 3 months;\n* no changes in diabetes medication in the previous 6 months;\n* no prescription for any hypoglycaemic agent within the previous 4 weeks or taking a consistent dose of one or more oral hypoglycaemic agents for more than 12 weeks;\n* owning smartphone\u002Fmobile phone with an internet connection;\n* capable to consent;\n* fulfilling and signing the informed consent;\n* with self-reported competencies of communicating verbally in local language (corresponding to a level of Italian language knowledge =\\>A2 of the CEFR levels).\n\nExclusion Criteria:\n\n* acute medical problems: myocardial infarction or stroke within 6 months, difficulty in exercise and physical activity due to spinal disease (intervertebral disc prolapse, spinal stenosis, etc.), joint disease, or major surgery at the time of screening, painful arthritis, spinal stenosis, amputation, painful foot lesions or neuropathy limiting balance and mobility, advanced Parkinson's disease and\u002For neuromuscular disorders, advanced dementia, metastatic cancer, in long-term immunosuppressant therapy, significant visual or hearing impairment, uncontrolled hypertension or other serious conditions that restrict their participation in the study, severe\u002Fmajor depression and other relevant psychiatric disorders;\n* estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m2;\n* plan to receive surgery that could limit physical activity during the study period;\n* pregnant or breastfeeding;\n* participation in another studies;\n* lack of written informed consent.","18 Years",{"count":53,"type":21},388,"INTERVENTIONAL",[56],"NA","The primary objective of this Randomized Clinical Trial is to improve the self-management (SM) competencies of patients affected by Type 2 Diabetes Mellitus (T2DM) living in the Marche region (Italy) through the support of a mobile health (m-health) solution personalised by the diabetologist and integrated with the Electronic Patient Record (EPR), assessed through the change in glycated haemoglobin (HbA1c) levels (%) from baseline to the end of the intervention (primary outcome).\n\nResearchers will compare the use of the m-health solution (treated group) to usual T2DM care (control group) in determining change in HbA1c levels (%). The intervention will start at the Diabetic Centres (CADs) where patients are currently followed up and will then take place in each participant's home\n\nParticipants of the treated group will:\n\n* receive dedicated training on the use of the m-health solution\n* receive the personalization of the m-health solution\n* use the m-health solution to: 1) track and view the data related to their health status (e.g., glycaemic status, lifestyle habits, diet) and treatment plane; 2) receive alerts and motivational messages; communicate with the Health Care Professionals (HCPs) of the Diabetic Centre (CAD) in case of need; 3) access to the educational material and to the technical assistance, when needed.\n\nHCPs will be able to monitor the patients' data and clinical parameters and to communicate with the patients. After a baseline evaluation (T0), three follow-up evaluations will be conducted at 6, 12 and 18 months (T1-T2-T3 respectively) , during the usual physician' visits, as part of clinical routine.\n\nThe evaluation phases (T0, T1, T2, T3) will be conducted through data derived from: 1) self-administered and paper-based questionnaires, validated in the Italian language; 2) the clinical assessment of patients; 3) the m-health solution, as data automatically derived from the m-health solution; 4) a focus group carried out in a subsample of participants.\n\nData regarding different health-related areas (T2DM severity; medication adherence; lifestyle habits; self-efficacy related to management of the disease; quality of life), usability of the m-health solution, participants' experience with the intervention, utilization of the m-health solution by the patients, and the cost-effectiveness of the intervention, will be evaluated.\n\nPatients participating in the study will not be required to make any additional visits or undergo any laboratory analysis beyond those specified in their therapeutic plan.",[59],"Diabetes Type 2",[61,62,63,64,65],"self-management","digital solution","Diabete type 2","Chronic diseases","glycated hemoglobin","RECRUITING","2025-12-30",{"date":69,"type":35},"2025-12-31",{"date":71,"type":35},"2025-10-13",{"date":39,"type":21},{"name":41,"class":42},13,""]