[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580834":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":61,"collaborators":64,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Cagliari","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group: CGA based individualized multimodal plan of care","EXPERIMENTAL","After randomization patients allocated to intervention arm will be treated following and individualized multimodal plan of care based on the results of the comprehensive geriatric assessment.",[13],"Other: Geriatric Assessment",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm: usual care control group","NO_INTERVENTION","After randomization patients allocated to this arm will be trated and followed by diabetologist according to current guidilenes (Usual Care)",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Geriatric Assessment","The intervention group will undergo Geriatric Assessment in addition to diabetes usual care.\n\nUsual care for both the Control and Intervention groups will be assured by a diabetologist according to in-use guidelines.\n\nAfter randomization, a geriatrician will administer a thorough CGA to all participants allocated to the intervention groups. CGA results will be used to diagnoses or drug review; to identify specific treatment goals according to the functional status of the patient and to incorporate Patient-preferred outcome in the management of diabetes and comorbidities. Using the results of the CGA the geriatricians along with the attending diabetologist and additional healthcare professional, if needed, will implement a personalized diagnostic and therapeutic plan of care. Participants in the Control group will receive no additional intervention over and above usual care.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Angelo Scuteri, MD PhD","CONTACT","+393334564136","angelo.scuteri@unica.it",[31,53],{"facility":32,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Azienda Ospedaliero-Universitaria di Cagliari","RECRUITING","Cagliari","09124","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],9.11917,39.23054,{"lat":42,"lon":41},[45,47,51],{"name":26,"role":27,"phone":46,"phoneExt":18,"email":29},"00390706754035",{"name":48,"role":27,"phone":49,"phoneExt":18,"email":50},"Diego Mastino, MD","003907051096110","d.mastino@aoucagliari.it",{"name":26,"role":52,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"facility":54,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":55,"geoPoint":57,"contacts":58},"Azienda Ospedaliero-Universitaria",{"type":39,"coordinates":56},[41,42],{"lat":42,"lon":41},[59],{"name":26,"role":27,"phone":60,"phoneExt":18,"email":29},"0039",{"type":52,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Angelo Scuteri","Full Professor of Internal Medicine, University of Cagliari (Italy) - Director Internal Medicine Unit, University Hospital, Cagliari (Italy)",[65,67],{"name":66,"class":6},"University of Milano Bicocca",{"name":68,"class":6},"Università degli Studi di Ferrara","100580834","comprehensive-approach-to-reduce-elderly-functional-decline-in-diabetes-the-cared-study-100580834",false,"NCT06842459","Comprehensive Approach to Reduce Elderly Functional Decline in Diabetes: the CARED Study","Prevention of Functional Decline by Multimodal Intervention in Older Patients With Diabetes","CARED","Inclusion criteria:\n\n* Age ≥75 years;\n* Diagnosis of diabetes mellitus;\n* Functional limitation defined as a Short Physical Performance Battery (SPPB) score between 4 (included) and 9 (included), and\n* Willingness to participate in the study.\n\nExclusion criteria:\n\n* Severe disability in basic activity of daily living (dependency in 3 or more activities),\n* Not being resident in the hospital catchment area; residence in long-term care;\n* Diagnosis of schizophrenia, other psychotic or bipolar disorder, or severe cognitive impairment (MMSE score \\\u003C 21\u002F30);\n* Alcohol abuse (\\> 14 drinks per week);\n* Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., the early stage breast or prostate cancer);\n* Respiratory insufficiency requiring regular use of supplemental oxygen;\n* Recent (\\\u003C 6 months) myocardial infarction;\n* Class IV NYHA heart failure;\n* Severe chronic kidney disease (stage V, dialysis);\n* Decompensated liver cirrhosis;\n* Inability or unwillingness to provide informed consent.","ALL","75 Years","110 Years",{"count":81,"type":82},180,"ESTIMATED","INTERVENTIONAL",[85],"NA","Importance. Conventionally, treatment goals for diabetic patients primarily target glycemic levels and traditional cardiovascular risk factors (blood pressure, lipids) control to reduce macro- and micro-vascular complications. More recently, the relevance of assessing functional status in older diabetic patients has emerged. A knowledge gap exists regarding the risk of functional dependency in older diabetic patients and on the impact of Comprehensive Geriatric Assessment (CGA) on the achievement of easily calculated and objective patient-centered outcomes.\n\nObjective To investigate if a personalized plan of care base on CGA would reduce the risk of functional decline over time in older patients with diabetes as compared to usual care Design. Individual patient randomized controlled trial comparing intervention with usual care.\n\nSetting. Three hospitals in Cagliari, Ferrara, and Milano, Italy. Participants. One-hundred and eighty diabetic patients aged ≥75 years. Intervention. Usual care for both the Control and Intervention groups will be assured by a diabetologist according to in-use guidelines. After randomization, a geriatrician will administer a thorough CGA to all participants allocated to the intervention groups. CGA will be used to identify specific treatment goals according to the functional status of the patient and to incorporate Patient-preferred outcome in the management of diabetes and comorbidities. Using the results of the CGA the geriatricians along with the attending diabetologist and additional healthcare professionals, if needed, will implement a personalized diagnostic and therapeutic plan of care. Participants in the Control group will receive no additional intervention over and above usual care.\n\nFollow-up. Follow-up visit will be scheduled at 6 and 12 months after randomization.\n\nMain outcome measures. The primary outcome will be represented by the change in physical performance, assessed by change in the Short Physical Performance Battery (SPPB) score over time.\n\nSecondary outcomes will be represented by change in cognitive function, sarcopenia, dependency, glycated hemoglobin levels, and rate of hospitalization as well as Time-at-home.\n\nExpected Results. The CGA-driven intervention applied to older diabetic patients will have significant benefits on functional outcomes as compared to usual care.\n\nImplications. Multimodal intervention in older diabetic patients will significantly impact on the ageing population and allow a novel process to be developed for interventions that produce the maximum disability-free life years lived combined with the highest quality of life for this vulnerable and often neglected group of adults.",[88,89],"Diabetes","Older People",[91,92,93,94],"diabetes","older people","geriatric assessment","functional outcomes","2025-02-18",{"date":97,"type":98},"2025-02-24","ACTUAL",{"date":100,"type":98},"2025-02-03",{"date":102,"type":82},"2026-10",{"name":5,"class":6},2]