[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656656":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":42,"studyPopulation":42,"armGroups":45,"interventions":51,"overallOfficials":55,"centralContacts":60,"locations":66,"responsibleParty":89,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":42,"enrollmentInfo":105,"targetDuration":42,"studyType":108,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":69,"whyStopped":42,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"University of Milano Bicocca","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"ICOPE-based program feasibility, operationalized as the study completion rate at 6 months.","This retention rate is defined as the proportion of enrolled participants who complete the entire study pathway, with a prespecified feasibility target of ≥80%.","6 months",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Prevalence of IC-domain impairments","Baseline prevalence of impairment in each IC domain, as identified through the first-level screening and further confirmed through the in-depth assessment","Baseline",{"measure":19,"description":20,"timeFrame":17},"Prevalence of frailty","Baseline prevalence of frailty",{"measure":22,"description":23,"timeFrame":24},"Adherence to multidomain interventions","Mean proportion of prescribed intervention sessions completed","3 months",{"measure":26,"description":27,"timeFrame":28},"Participant satisfaction","Likert-5 point questionnaire","3 months and 6 months",[30,34],{"measure":31,"description":32,"timeFrame":33},"IC domain-specific measures changes","Longitudinal changes in IC-domain specific measures (in-depth multidimensional assessment)","Baseline to 3 month and 6 month",{"measure":35,"description":36,"timeFrame":37},"Falls, emergency department visits, hospitalizations, and vital status","Number of falls, emergency department visits, hospitalizations, and vital status at follow-up visits","3 month and 6 month",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":6,"observationalModel":42,"timePerspective":42,"maskingInfo":43},"NA","SINGLE_GROUP","Prospective, single-arm feasibility study of a multidomain intervention conducted at two Active Ageing Centers (AACs) in Monza, Lombardy (Italy).",null,{"masking":44,"maskingDescription":42,"whoMasked":42},"NONE",[46],{"label":47,"type":48,"description":42,"interventionNames":49},"Multidomain intervention","EXPERIMENTAL",[50],"Other: Multidomain intervention",[52],{"type":6,"name":47,"description":53,"armGroupLabels":54,"otherNames":42},"Following the in-depth assessment, each participant receives a personalized 3-month multidomain intervention plan tailored to identified IC impairments, clinical status, preferences, and social context. A multidisciplinary team provides multicomponent physical exercise based on Vivifrail for all participants, alongside targeted interventions for cognitive impairment, overt malnutrition or risk of malnutrition, depressive symptoms, sensory deficits, and social isolation. Regular medications are also reviewed using STOPP\u002FSTART criteria, with recommendations communicated to the participant and primary care physician.",[47],[56],{"name":57,"affiliation":58,"role":59},"Giuseppe Bellelli, Medical doctor, full professor","University of Milano-Bicocca, IRCCS Foundation San Gerardo dei Tintori","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":42,"email":65},"Maria Cristina Ferrara, Medical doctor and PhD","CONTACT","+39 0392339719","mariacristina.ferrara@unimib.it",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Active Ageing Centers (organized by Sociosfera)","RECRUITING","Monza","Monza E Brianza","20900","Italy","IT",{"type":76,"coordinates":77},"Point",[78,79],9.27246,45.58005,{"lat":79,"lon":78},[82,86],{"name":83,"role":63,"phone":84,"phoneExt":42,"email":85},"Sociosfera president","+39 3408747301","a.lex@sociosfera.it",{"name":87,"role":63,"phone":42,"phoneExt":42,"email":88},"Manuela Grimoldi","m.grimoldi@sociosfera.it",{"type":90,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[92],{"name":93,"class":94},"Cariplo Foundation","UNKNOWN","100656656","multidomain-intervention-based-on-icope-100656656",false,"NCT07829120","Multidomain Intervention Based on ICOPE","FORMULA 100: an ICOPE-based Multidomain Intervention to Promote Active and Healthy Ageing.","FORMULA 100","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Attendance at one of the Active Ageing Centers participating in the project\n* Evidence of impairment in at least one key domain of intrinsic capacity, as identified through the first-level ICOPE screening\n* Ability to walk independently (with or without a walking aid)\n* Ability to communicate and cooperate with the research team\n\nExclusion Criteria:\n\n* Clinical conditions precluding completion of the first-level ICOPE screening or safe participation in the study, including severe dementia, bilateral blindness, end-stage diseases (e.g., Child-Pugh class C liver cirrhosis, stage 5 chronic kidney disease, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group D, end-stage heart failure, or advanced cancer)\n* Concurrent participation in another clinical study\n* Refusal or inability to provide written informed consent","ALL","65 Years",{"count":106,"type":107},250,"ESTIMATED","INTERVENTIONAL",[39],"FORMULA 100 is a prospective, single-arm feasibility study conducted at two Active Ageing Centers in Monza, Italy, involving community-dwelling adults aged 65 years and older. The study will test whether an Integrated Care for Older People (ICOPE)-based care pathway can be implemented in this setting.\n\nParticipants will first be screened for possible decline in intrinsic capacity (IC). Those enrolled will then undergo a multidimensional assessment and receive a personalized 3-month intervention tailored to their needs. The intervention may address physical, cognitive, nutritional, psychological, sensory, and social needs and may also include a review of medications.\n\nParticipants will be reassessed after 3 months and again after 6 months. The main study outcome is the proportion of participants who complete the 6-month follow-up. About 300 people are expected to be screened, with a target enrollment of 250 participants.",[112],"Intrinsic Capacity",[114,115,116],"intrinsic capacity","multidomain intervention","older adults","2026-09-14",{"date":119,"type":120},"2026-09-18","ACTUAL",{"date":122,"type":120},"2025-12-01",{"date":124,"type":107},"2027-03-31",{"name":5,"class":6},1]