Nctid:
NCT06611228
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000073496", "term"=>"Frailty"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M1175", "name"=>"Frailty", "asFound"=>"Frailty Syndrome", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Pragmatic, randomized controlled (parallel-arm cluster), non-drug interventional clinical study"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>288}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-01-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-20", "studyFirstSubmitDate"=>"2024-09-02", "studyFirstSubmitQcDate"=>"2024-09-20", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Assess the impact of the MDI on cardiovascular risk factors.", "timeFrame"=>"Baseline, 6 months", "description"=>"Impact of MDI on lifestyle and inactivity, blood pressure, smoking, cholesterol level, and blood glucose."}, {"measure"=>"Evaluate the effect of the MDI on participants&amp;amp;amp;#39; social relationships.", "timeFrame"=>"3 months, 6 months", "description"=>"Effect of the MDI on improving social relationships, assessed using the Lubben Social Network Scale (12 items scale)"}, {"measure"=>"Evaluate the impact of fortified food consumption on microbiota composition and bowel alterations in a subgroup of patients not undergoing antibiotic therapy (ancillary study).", "timeFrame"=>"Baseline, Through Discharge an Average of 10 days", "description"=>"Evaluation of the impact of fortified food consumption on faecal analysis in a subgroup of patients not undergoing antibiotic therapy"}, {"measure"=>"Assess participants access to (and frequency of use of) technological resources.", "timeFrame"=>"Through Discharge an Average of 10 days, 3 months", "description"=>"Number of app accesses."}, {"measure"=>"Assess the effect of the MDI on mood of participants", "timeFrame"=>"Baseline, 3 months, 6 months", "description"=>"Effect of the MDI on mood, assessed using the Geriatric Depression Scale (GDS, 0-30)"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on the Free Triiodothyronine/Free Thyroxine (FT3/FT4) concentration in the MDI group compared to controls"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline", "description"=>"Effect of the MDI on partipants according to Serum Amyloid Beta (Aβ) concentration categories"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline", "description"=>"Effect of the MDI on partipants according to their Serum Phosphorylated Tau at Threonine 181 (p-tau181), p-tau217, p-tau231 concentrations"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on high-sensitivity C-reactive protein (hs-CRP, measured in mg/L) concentration of the MDI group compared to controls"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on Erythrocyte sedimentation rate (ESR, measured in mm/h) of the MDI group compared to controls"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on interleukin 6 (IL-6, measured in pg/mL) concentration of the MDI group compared to controls"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on the Neurofilament Light Chain (NF-L, measured in pg/mL) concentration in the MDI group compared to controls"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on the Soluble Receptor for Advanced Glycation End-products (s-RAGE, measured in ng/mL) concentration in the MDI group compared to controls"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on the Fibroblast Growth Factor 1 concentration (FGF-1, measured in pg/mL) in the MDI group compared to controls"}, {"measure"=>"Evaluate the effect of the MDI on biomarkers of aging", "timeFrame"=>"Baseline, 6 months", "description"=>"Changes on the Growth Differentiation Factor 15 concentration (GDF-15, measured in pg/mL), in the MDI group compared to controls."}], "primaryOutcomes"=>[{"measure"=>"Evaluate the feasibility of home-based MDI with technological support", "timeFrame"=>"3 months, and 6 months", "description"=>"Feasibility of home-based MDI with technological support, evaluated using Patient Reported Experience Measures (PREMs), questionnaires measuring the patients' perceptions of their experience whilst receiving care"}, {"measure"=>"Evaluate the participant adherence to the protocol", "timeFrame"=>"through study completion, an average of 1 year", "description"=>"Evaluate the participant adherence to the protocol assessing the number of drop-out and overall retention rates"}, {"measure"=>"Assess the effect of the MDI on motor function at discharge from the AGU", "timeFrame"=>"Baseline, Discharge (after an average hospital stay of 10 days)", "description"=>"Effect of the intervention in terms of motor function, assessed using the Short Physical Performance Battery (SPPB, from 0 to 12)"}], "secondaryOutcomes"=>[{"measure"=>"Assess the effect of the MDI on readmissions at 6 months follow-up.", "timeFrame"=>"6 months", "description"=>"Effect of the MDI in reducing hospital readmissions at 6 months"}, {"measure"=>"Assess the effect of the MDI on readmissions at 3 months follow-up.", "timeFrame"=>"3 months", "description"=>"Effect of the MDI in reducing hospital readmissions at 3 months"}, {"measure"=>"Evaluate the effect of the MDI on quality of life at follow-up.", "timeFrame"=>"3 months, 6 months", "description"=>"Effect of the MDI on participants' quality of life at follow-up, evaluated using the EuroQol EQ-5D 5L, a descriptive system comprising five dimensions (mobility, self-care, usual activities, discomfort, and anxiety/depression), each dimension with five response levels (no problems, slight problems, moderate problems, severe problems, unable to/extreme problems)."}, {"measure"=>"Evaluate the effect of the MDI on in-hospital mortality", "timeFrame"=>"From Admission Through Discharge, an Average of 10 days", "description"=>"Evaluate the effect of the MDI on in-hospital mortality"}, {"measure"=>"Evaluate the effect of the MDI on mortality at follow-up.", "timeFrame"=>"3 months, 6 months", "description"=>"Evaluate the effect of the MDI on mortality at follow-up."}, {"measure"=>"Evaluate the effect of the MDI on dietary intake and nutritional status at follow-up.", "timeFrame"=>"Baseline, 3 months, 6 months", "description"=>"Effect of the MDI in improving dietary intake and nutritional status at follow-up, assessed using the Mediterranean Diet Scale (MDScale, that includes nine components) and Mini Nutritional Assessment-Short Form (MNA-SF, 0-14)"}, {"measure"=>"Evaluate the effect of the MDI on changes in frailty levels at follow-up.", "timeFrame"=>"Baseline, 3 months, 6 months", "description"=>"Effect of the MDI in reducing frailty at follow-up, assessed using the Clinical Frailty Scale (CFS, 0-9) and Primary Care Frailty Index (PC-FI)"}, {"measure"=>"Assess the effect of the MDI on fall events", "timeFrame"=>"Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months", "description"=>"Effect of the MDI in reducing the incidence of falls during hospitalization and at home, evaluated through the number of falls and the Tinetti Scale (0-28) occurred within the study period"}, {"measure"=>"Evaluate the effect of the MDI on in-hospital complications", "timeFrame"=>"Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months", "description"=>"Effect of the MDI in reducing the incidence of in-hospital complications as sepsis, urinary infections, blood infections, and pressure ulcers."}, {"measure"=>"Assess the effect of the MDI on sleep quality", "timeFrame"=>"Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months", "description"=>"Effect of the MDI on sleep quality during hospitalization and at home, assessed using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire consists of a combination of Likert-type and open-ended questions (which can later be converted into scaled scores using appropriate guidelines)."}, {"measure"=>"Assess the effect of the MDI on the incidence of delirium during hospitalization", "timeFrame"=>"From Admission Through Discharge, an Average of 10 days", "description"=>"Effect of the MDI in reducing incident delirium during hospitalization, diagnosed according to international guidelines (DSM V) and assessed using the Modified Richmond Agitation Screening Scale (m-RASS, scoring from -5 to +4), 4AT (scoring, from 0 to 12), and Delirium Rating Scale (DRS-revised, 13 items, each item is rated on a scale of 0- 2/3)"}, {"measure"=>"Assess the effect of the MDI on cognitive performance at follow-up.", "timeFrame"=>"Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months", "description"=>"Effect of the MDI on cognitive performance (assessed using the Cognitive Reserve Index questionnaire (CRIq), Addenbrooke Cognitive Examination - Revised (ACE-R), Trail Making Test (TMT) parts A and B)"}, {"measure"=>"Assess the effect of the MDI on functional performance at follow-up", "timeFrame"=>"Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months", "description"=>"Assessed using Basic Activities of Daily Living (ADL 0-6), Instrumental Activities of Daily Living (IADL 0-8), Barthel Index at follow-up (0-100)"}, {"measure"=>"Assess the effect of the MDI on motor performance at follow-up.", "timeFrame"=>"Baseline, From Admission Through Discharge, an Average of 10 days, 3 months, 6 months", "description"=>"Assessed using SPPB (0-12), hand grip strength (Kg)"}, {"measure"=>"Assess the acceptability of technological solutions during hospitalization and at follow-up.", "timeFrame"=>"Discharge (after an average hospital stay of 10 days), 3 months, and 6 months", "description"=>"Acceptability of technological solutions through the administration of specific questionnaires"}, {"measure"=>"Evaluate the cost impact of the MDI on the healthcare system.", "timeFrame"=>"Discharge (after an average hospital stay of 10 days), 3 months, and 6 months", "description"=>"Costs of the MDI on the healthcare system, evaluated through the incremental cost-effectiveness ratio"}, {"measure"=>"Evaluate the effect of the MDI on the length of hospital stay.", "timeFrame"=>"Discharge (after an average hospital stay of 10 days)", "description"=>"Effect of the MDI in reducing the length of hospital stay"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Hospital Acquired Disability", "Frailty Syndrome", "Comprehensive Geriatric Assessment", "Prevention", "Integrated Multidomain Interventions", "Telemedicine", "Telemonitoring", "Outcomes", "Hospital"], "conditions"=>["Frailty Syndrome", "Aging"]}, "referencesModule"=>{"references"=>[{"pmid"=>"31275941", "type"=>"BACKGROUND", "citation"=>"Belloni G, Cesari M. Frailty and Intrinsic Capacity: Two Distinct but Related Constructs. Front Med (Lausanne). 2019 Jun 18;6:133. doi: 10.3389/fmed.2019.00133. eCollection 2019."}, {"pmid"=>"31609229", "type"=>"BACKGROUND", "citation"=>"Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4."}, {"pmid"=>"32542377", "type"=>"BACKGROUND", "citation"=>"Thillainadesan J, Scott IA, Le Couteur DG. Frailty, a multisystem ageing syndrome. Age Ageing. 2020 Aug 24;49(5):758-763. doi: 10.1093/ageing/afaa112."}, {"pmid"=>"31950775", "type"=>"BACKGROUND", "citation"=>"Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16."}, {"pmid"=>"28579766", "type"=>"BACKGROUND", "citation"=>"Dedeyne L, Deschodt M, Verschueren S, Tournoy J, Gielen E. Effects of multi-domain interventions in (pre)frail elderly on frailty, functional, and cognitive status: a systematic review. Clin Interv Aging. 2017 May 24;12:873-896. doi: 10.2147/CIA.S130794. eCollection 2017."}, {"pmid"=>"29969614", "type"=>"BACKGROUND", "citation"=>"de Souto Barreto P, Rolland Y, Maltais M, Vellas B; MAPT Study Group. Associations of Multidomain Lifestyle Intervention with Frailty: Secondary Analysis of a Randomized Controlled Trial. Am J Med. 2018 Nov;131(11):1382.e7-1382.e13. doi: 10.1016/j.amjmed.2018.06.002. Epub 2018 Jul 1."}, {"pmid"=>"25771249", "type"=>"BACKGROUND", "citation"=>"Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. 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BMC Med. 2016 Dec 22;14(1):215. doi: 10.1186/s12916-016-0763-7."}, {"pmid"=>"20843964", "type"=>"BACKGROUND", "citation"=>"Cooper R, Kuh D, Cooper C, Gale CR, Lawlor DA, Matthews F, Hardy R; FALCon and HALCyon Study Teams. Objective measures of physical capability and subsequent health: a systematic review. Age Ageing. 2011 Jan;40(1):14-23. doi: 10.1093/ageing/afq117. Epub 2010 Sep 15."}, {"pmid"=>"24590568", "type"=>"BACKGROUND", "citation"=>"Bellelli G, Morandi A, Davis DH, Mazzola P, Turco R, Gentile S, Ryan T, Cash H, Guerini F, Torpilliesi T, Del Santo F, Trabucchi M, Annoni G, MacLullich AM. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing. 2014 Jul;43(4):496-502. doi: 10.1093/ageing/afu021. Epub 2014 Mar 2. Erratum In: Age Ageing. 2015 Jan;44(1):175. doi: 10.1093/ageing/afu181."}], "seeAlsoLinks"=>[{"url"=>"https://apps.who.int/iris/handle/10665/186463", "label"=>"Organization WH. World report on ageing and health \\[Internet\\]. Geneva PP - Geneva: World Health Organization"}, {"url"=>"https://apps.who.int/iris/handle/10665/258981", "label"=>"Organization WH. Integrated care for older people: guidelines on community-level interventions to manage declines in intrinsic capacity \\[Internet\\]. Geneva PP - Geneva: World Health Organization;"}]}, "descriptionModule"=>{"briefSummary"=>"The aim of this study is to assess whether a multidomain, multidisciplinary intervention (MDI), enhanced by technological solutions, effectively improves the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty. Additionally, the study will evaluate the feasibility and acceptability of delivering these interventions remotely via technology after hospital discharge.\n\nParticipants will:\n\n* Receive an MDI during their hospital stay and continue with remote at-home support for 3 months, or receive usual care.\n* Attend outpatient clinics for follow-up assessment at 3 and 6 months.", "detailedDescription"=>"The \"Optimizing Prevention of Hospital-Acquired Disability Through Integrated Multidomain Interventions (OPTIMAge-IT)\" study will evaluate impact of a MDI multidisciplinary approach, enhanced by technological solutions, on the functional and cognitive status of older hospitalized patients at risk of disability or worsening frailty.\n\nAdditionally, the study will evaluate the feasibility and acceptability of delivering MDIs remotely via technology after hospital discharge. Using a parallel cluster-randomized design, approximately 300 patients will be recruited from eight Acute Geriatric Units (AGUs) located in eight acute hospitals evenly distributed across Northern, Central, and Southern Italy.\n\nEligible patients will be aged 70 years or older, with mild to moderate frailty, capable of ambulation with or without assistance and able to communicate and collaborate with the research team. Participants will use smart technologies, such as smartwatches, and tablets, for guided physical activity and remote monitoring. A multidisciplinary team -including a geriatrician, a nurse, a physiotherapist, a clinical nutrition expert, a neuropsychologist and a digital coach- will assist patients in the intervention group, supervising the MDI approach during hospitalization and at the 3-month follow-up. Blood-based biomarkers and fecal samples for gut microbiome analysis will be collected for patients in the intervention group, to support frailty stratification at baseline and help define the trajectories of functional and cognitive changes from baseline to follow-up assessments.\n\nAfter discharge, patients in the intervention group will continue MDI at home for 12 weeks, with follow-up visits at 3 and 6 months. The control group will receive a follow-up visit at 6 months."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["OLDER_ADULT"], "minimumAge"=>"70 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age \\>70 years;\n* Mild to moderate frailty, defined by a panel of tools agreed upon by the group of researchers involved in the study (Primary Care Frailty Index \\[PC-FI\\] between 0.07 and 0.21, Clinical Frailty Scale \\[CFS\\] 4-6);\n* Ability to walk with or without assistance\n* Ability to communicate and cooperate with the research team;\n* Ability to sign informed consent.\n\nExclusion Criteria:\n\n* Expected hospital stay duration \\<3 days;\n* Estimated prognosis quoad vitam \\<12 months;\n* Persistent clinical instability, indicated by a NEWS2 score \\>5 (assessed within 48 hours of admission) and/or the presence of delirium (4AT \\>4);\n* History of schizophrenia, major depression, bipolar disorder, or psychosis;\n* Severe sensory deficits (visual and auditory);\n* Presence of a nasogastric tube or percutaneous endoscopic gastrostomy (PEG);\n* Severe cardiac conduction disorder (e.g., third-degree atrioventricular block), uncontrolled arrhythmia, new Q wave in the past six months, or ST segment depression (\\>3 mm) on the electrocardiogram;\n* Terminal stage oncological or organic disease (e.g., Child-Pugh C cirrhosis, stage V renal disease, GOLD stage D chronic obstructive pulmonary disease, end-stage heart failure);\n* Residence in a nursing home before hospital admission;\n* Presence of dissected aortic aneurysm, severe aortic stenosis, acute endocarditis/pericarditis, acute thromboembolism, uncontrolled hypertension (\\>180/100 mmHg) or postural hypotension, uncontrolled hypoglycemia, recent fracture within the last month, or any other medical condition that hinders the execution of physical activity according to clinical judgment;\n* Any condition that prevents safe participation in the intervention and/or cooperation with the study;\n* Concurrent participation in other clinical studies;\n* Clinical conditions or situations significantly different from the condition under study, which in the investigator's opinion could interfere with the study or prevent optimal participation;\n* Participants refusal to participate in the study."}, "identificationModule"=>{"nctId"=>"NCT06611228", "acronym"=>"OPTIMAge-IT", "briefTitle"=>"Optimizing Prevention of Hospital-Acquired Disability Through Multidomain Interventions", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Milano Bicocca"}, "officialTitle"=>"Optimizing Prevention of Hospital-acquired Disability Through Integrated Multidomain Interventions: the Age-IT Project", "orgStudyIdInfo"=>{"id"=>"OPTIMAge-IT"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Intervention Group", "description"=>"The interventions include:\n\n* Physical Exercise: Tailored sessions with the VIVIFRAIL exercise protocol, monitored with accelerometers, and supported by a physical activity kit.\n* Nutrition: Mediterranean diet with education on nutrient balance and avoiding ultra-processed foods.\n* Health \\& Sleep: Promotion of healthy habits, fall prevention, sleep hygiene, and targeted sleep disorder treatments.\n* Polypharmacotherapy: Review and adjustment of medications as needed.\n* Cognition: Cognitive rehabilitation using technology and educational videos.\n* Environment: Adjustments to create an \"older-friendly\" Acute Unit, including modified routines and extended visiting hours.", "interventionNames"=>["Other: Multidomain Interventions"]}, {"type"=>"NO_INTERVENTION", "label"=>"Control Group", "description"=>"Centers randomized to the control group will follow usual care protocols. However, all participants in this group will receive standardized leaflets at discharge, providing physical, nutritional, and behavioral advice."}], "interventions"=>[{"name"=>"Multidomain Interventions", "type"=>"OTHER", "description"=>"Multidomain Interventions The intervention group will receive a personalized MDI approach from a multidisciplinary team, including a digital coach, physiotherapist, clinical nutrition expert, neuropsychologist, geriatrician, and nurse. This approach will encompass physical activity program, nutritional interventions, cognitive training and stimulation, medication reconciliation, coaching on the use of technological supports, and group activities. Environmental modifications at home will also be proposed", "armGroupLabels"=>["Intervention Group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Giuseppe Bellelli, MD", "role"=>"CONTACT", "email"=>"giuseppe.bellelli@campus.unimib.it", "phone"=>"3392777327"}, {"name"=>"Giuseppe Bellelli, MD", "role"=>"CONTACT"}], "overallOfficials"=>[{"name"=>"Giuseppe Bellelli, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Università di Milano-Bicocca"}, {"name"=>"Giuseppe Bellelli, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Università di Milano-Bicocca"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Milano Bicocca", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}