Nctid:
NCT06224556
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000073496", "term"=>"Frailty"}, {"id"=>"D000002908", "term"=>"Chronic Disease"}, {"id"=>"D000073296", "term"=>"Noncommunicable Diseases"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}], "browseLeaves"=>[{"id"=>"M1175", "name"=>"Frailty", "asFound"=>"Frailty", "relevance"=>"HIGH"}, {"id"=>"M6147", "name"=>"Chronic Disease", "asFound"=>"Chronic Disease", "relevance"=>"HIGH"}, {"id"=>"M1156", "name"=>"Noncommunicable Diseases", "asFound"=>"Non-Communicable Chronic Diseases", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "asFound"=>"Chronic", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["CARE_PROVIDER"], "maskingDescription"=>"The General Practitioners (GPs) involved will be randomised in clusters in a 1:1 ratio, therefore one group of GPs will enrol patients for the Intervention Group and a second group of GPs will include patients for the Control Group.\n\nTherefore, the role of GPs are masked."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"The Intervention Group will receive the Personlized Prevention Program (PPP)\n\nbe evaluated by a Comprehensive Geriatric Assessment thanks to the Multidimensional Prognostic Index (MPI) questionnaire."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1216}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-06-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-08", "completionDateStruct"=>{"date"=>"2025-05", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-08-27", "studyFirstSubmitDate"=>"2024-01-05", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-08-28", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-05", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Adherence at the PPP", "timeFrame"=>"6 and 12 months", "description"=>"Adherence at the Personalized Prevention Program by the Intervention Group"}, {"measure"=>"Psychological Well-being", "timeFrame"=>"Baseline, 6 and 12 months", "description"=>"Psychological well-being assessed to the Intervention Group"}, {"measure"=>"Resilience", "timeFrame"=>"Baseline, 6 and 12 months", "description"=>"Resilience outcome evaluated in the Intervention Group"}, {"measure"=>"Lactate in the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"Saliva analyses for the Lactate parameter"}, {"measure"=>"NAD/NADH in the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"Saliva analyses for theNAD/NADH parameter"}, {"measure"=>"TBARS in the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"Saliva analyses for the TBARS parameter"}, {"measure"=>"TNF-alfa in the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"Saliva analyses for theTNF-alfa parameter"}, {"measure"=>"IL-1b in the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"Saliva analyses for the IL-1b parameter"}, {"measure"=>"IL-6 in the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"Saliva analyses for the IL-6 parameter"}, {"measure"=>"IL-8 in the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"Saliva analyses for the IL-8 parameter"}, {"measure"=>"Microbioma saliva analysis in a sub-group of the Intervention Group", "timeFrame"=>"After the saliva collection at the baseline", "description"=>"The microbioma saliva sample will be analysed in 210 subjects from the Intervention Group through the DNA GENOTEK OME-505 Omnigene Oral Collection Kits for Nucleic Acid Saliva"}], "primaryOutcomes"=>[{"measure"=>"Hospitalization rate", "timeFrame"=>"12 months", "description"=>"Unplanned hospitalization rate"}], "secondaryOutcomes"=>[{"measure"=>"Composed outcome", "timeFrame"=>"6 and 12 months", "description"=>"Composed outcome including: emergency access rate, hospitalization and institutionalization rates at 6 and 12 months after the baseline."}, {"measure"=>"Number of unplanned General Practitioners visits", "timeFrame"=>"12 months", "description"=>"Unplanned GPs visits"}, {"measure"=>"Mortality rate", "timeFrame"=>"6 and 12 months", "description"=>"mortality rate at 6 and 12 months"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Primary care setting", "Comprehensive Geriatric Assessment", "Older people", "Non-communicable chronic diseases", "Personalized Prevention Program", "Saliva collection"], "conditions"=>["Older People", "Non-Communicable Chronic Diseases"]}, "descriptionModule"=>{"briefSummary"=>"* Non-Communicable Diseases (NCDs) can accelerated the aging process and increase the frailty condition\n* The Comprehensive Geriatric Assessment (CGA) is the gold standard in the geriatric clinical context\n* Recently, in Italy the first Guidelines about the CGA in different settings for older people has been pubblicated\n* The CGA can identify older people at high risk of frailty who can benefit from a personalized prevention program\n* No studies has been investigated the effects of a personalized prevention program (PPP) based on the CGA in a primary care setting\n* The main hypothesis is that the CGA assessment can result in personalized prevention programs for older subjects in primary care settings with an effect in reducing the hospitalization rate and can be related to the biological paramters in NCDs", "detailedDescription"=>"The main aim of the project is to evaluate in older people the effectiveness of personalized preventive interventions based on the Comprehensive Geriatric Assessment (CGA) in the primary care setting and to explore biological process in Non-Communicable Disases (NCDs).\n\nThe study involves 1216 subjects enrolled by General Practitioners (GPs) in four different Italian Areas.\n\nThe GPs involved will be randomised to clusters in a 1:1 ratio, therefore one group of GPs will enrol patients for the Intervention Group and a second group of GPs will include patients for the Control Group.\n\nThe sample size:\n\nA recent Cochrane systematic review reports a significant reduction in the risk of unplanned hospitalisation in community-dwelling elderly persons treated with VMD compared to standard clinical practice (RR= 0.83; CI 95%: 0.70-0.99). Thus, assuming an incidence of unplanned hospitalisations in one year of 38.8% in the group receiving PPP compared to 47.7% in the group randomised to standard care and assuming a power of 80% and a type I error of 5%, a total of 972 participants will be enrolled. Furthermore, assuming a drop-out rate of 20% over the 1-year follow-up period, the final sample will be 1216 participants, 608 in each group\n\n608 subjects will be involved in the intervention group: they will receive the Personalized Prevention Program (PPP) and a saliva sample will be collected.\n\n608 subjects will be involved in the control group according to the normal clinical practice.\n\nBoth groups will be contacted at 6 and 12 months after the baseline for the follow-up.\n\nStatistical analyses:\n\nBaseline characteristics will be compared between the group receiving the CGA-based PPP intervention and the control group. Continuous variables will be compared using the t-Student test and categorical variables using the Chi-square test. The cumulative probability of the primary and secondary outcome will be estimated by Kaplan-Meier curve, using the log-rank test to assess differences between the two groups. To assess the risk associated with the primary outcome (rate of unplanned hospitalisation at 12 months) in subjects in the intervention group compared to subjects in standard care, the Hazard Ratio (HR) will be estimated by fitting a Cox model, after testing for proportional hazards. Similarly, the risk of secondary outcomes will be estimated."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["OLDER_ADULT"], "minimumAge"=>"65 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 65 years old and over\n* At least 1 non-communicable chronic disease\n* Signed informed consent\n\nExclusion Criteria:\n\n* not willing in partecipating in the study and no signed informed consent\n* \\<65 years old\n* without non-communicable chronic diseases"}, "identificationModule"=>{"nctId"=>"NCT06224556", "acronym"=>"PrimaCare_P3", "briefTitle"=>"A Personalized Prevention Program (PPP) Based on the Comprehensive Geriatric Assessment (CGA) for the Prevention of Multidimensional Frailty Related to Non-communicable Chronic Diseases (NCDs) in Older People", "organization"=>{"class"=>"OTHER", "fullName"=>"Ente Ospedaliero Ospedali Galliera"}, "officialTitle"=>"A Personalized Prevention Program (PPP) Based on the Comprehensive Geriatric Assessment (CGA) for the Prevention of Multidimensional Frailty Related to Non-communicable Chronic Diseases (NCDs) in Older People: a Practical Approach in Primary Care Setting", "orgStudyIdInfo"=>{"id"=>"PNRR-MAD-2022-12376781"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention Group", "description"=>"All the 608 patients will be evaluated by their General Practitioners through the Brief-MPI scale, which is based on the Comprehensive Geriatric Assessment (CGA).\n\nBased on the score obtained at the Brief-MPI, the patient will receive a Personalised Prevention Program (PPP) concerning the following domains: 1) motor, 2) cognitive, 3) nutritional, 4) polypharmacotherapy, 5) vaccination prevention, 6) basal and instrumental activities, 7) co-habitation. Patients will receive brochures containing practical advice and recommendations to be implemented over a 12-month period; in the case of high Brief-MPI risk scores, patients will be referred for specialist examinations and/or in-depth diagnostics.\n\nIn addition, saliva samples will be collected to assess biomarkers of oxidative stress and, in a subsample of 210 subjects, the composition of the oral microbiota will also be analysed.", "interventionNames"=>["Combination Product: Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control group", "description"=>"Patients will receive the standard clinical practice by their General Practitioners, without being evaluated by the CGA or receiving the personalized prevention program (PPP). No saliva sample will be collected."}], "interventions"=>[{"name"=>"Brief-MPI assessment (based on the Comprehensive Geriatric Assessment); Personalized Prevention Program", "type"=>"COMBINATION_PRODUCT", "description"=>"Patients will be evaluated at baseline and at 6 and 12 months after the baseline through the CGA, the Resilience Scale (RS-14 items) and the Psychological General Wellbeing Index short form.\n\nThe prevention program will be received at the baseline, so at the two follow-ups patients wiil asked the adherence to it and the level of satisfaction (Client Satisfaction Questionnaire - 8 items).\n\nSaliva sample will be collected and analyzed.", "armGroupLabels"=>["Intervention Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Bari", "status"=>"RECRUITING", "country"=>"Italy", "facility"=>"Polimedica Societa' Cooperativa", "geoPoint"=>{"lat"=>41.11148, "lon"=>16.8554}}, {"city"=>"Desenzano Del Garda", "status"=>"RECRUITING", "country"=>"Italy", "facility"=>"Medici Insieme Garda Valsabbia Societa' Cooperativa", "geoPoint"=>{"lat"=>45.47127, "lon"=>10.53559}}, {"city"=>"Firenze", "status"=>"RECRUITING", "country"=>"Italy", "facility"=>"Ambulatori medici", "geoPoint"=>{"lat"=>43.77925, "lon"=>11.24626}}, {"city"=>"Napoli", "status"=>"RECRUITING", "country"=>"Italy", "facility"=>"COMEGEN Società Cooperativa Sociale", "geoPoint"=>{"lat"=>40.85216, "lon"=>14.26811}}], "centralContacts"=>[{"name"=>"Alberto Pilotto", "role"=>"CONTACT", "email"=>"alberto.pilotto@galliera.it", "phone"=>"0039 0105634467"}, {"name"=>"Marina Barbagelata", "role"=>"CONTACT", "email"=>"marina.barbagelata@galliera.it"}], "overallOfficials"=>[{"name"=>"Alberto Pilotto", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Director of the Department of Geriatric Care, orthogeroatric and rehabilitation, EO Galliera Hospital, Genova, Italy"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Results referred to the groups of subjects will be published in one or more different papers with only statistically significant data with the description of statistical methods of the analyses. No individual or personal data will be shared."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Alberto Pilotto", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Director of Department of Geriatric Care, Orthogeriatrics and Rehabilitation", "investigatorFullName"=>"Alberto Pilotto", "investigatorAffiliation"=>"Ente Ospedaliero Ospedali Galliera"}}}}
