[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Keralty SAS. Colombia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100567051","effectiveness-of-a-socio-community-health-intervention-on-pre-frailty-in-older-adults-100567051",false,"NCT06663150","Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults","Effectiveness of a Health Intervention With a Socio-community Approach on Frailty in Older Adults With Pre-frailty","Inclusion Criteria:\n\n* Individuals ≥ 60 years old classified as pre-frail in the last 3 months and documented in their medical history.\n* Individuals who meet the requirements and provide voluntary informed consent for their participation.\n* Individuals available to remain in Bogotá D.C. during the study period.\n\nExclusion Criteria:\n\n* Individuals receiving care at community-focused medical centers.\n* Individuals attending community dining programs, physical activity programs, community groups, care blocks, volunteering, or other related activities.\n* Individuals who have experienced falls in the last 6 months with clinical consequences (hospitalization, fractures, traumatic brain injury).\n* Individuals with a clinical history of moderate cognitive impairment, neurodegenerative diseases (e.g., Parkinson's disease), and\u002For neuro-musculoskeletal disorders, active cancer, end-stage renal disease, unstable ischemic heart disease, uncontrolled arrhythmias, severe aortic stenosis, uncontrolled hypertension (\\>180\u002F100 mmHg), or advanced heart failure, exacerbation of chronic diseases (COPD, heart failure), unrehabilitated severe hearing loss, deafness, or blindness with communication limitations.\n* Acute conditions requiring hospitalization, such as acute myocardial infarction or urinary tract infections.\n* Bone fractures in the last 3 months.\n* Individuals unable to follow instructions or with behavioral changes that hinder their participation in the study.\n* Individuals with severe psychiatric illness that, in the physician's judgment, prevents proper adherence to the study intervention.\n* Institutionalized individuals in long-term care facilities.","ALL","60 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this study is: To evaluate the effectiveness of a health intervention with a socio-community approach on frailty in older adults with pre-frailty.\n\nSpecific Objectives:\n\nTo characterize the study population according to sociodemographic and clinical variables.\n\nTo evaluate the effect of the intervention on the functionality domain at 3 and 6 months.\n\nTo evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months.\n\nTo evaluate the effect of the intervention on the socio-community domain at 3 and 6 months.\n\nTo evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period.\n\nTo determine the proportion of participants who visited the emergency room during the study period.\n\nTo determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention.\n\nStudy Hypothesis\n\nThe mean frailty score pre-intervention is equal to the mean frailty score post-intervention.\n\nThe mean frailty score pre-intervention is different from the mean frailty score post-intervention.",[26],"Frail Elderly Syndrome",[28,29,30],"Prefrailty","Frailty","Older Adults","NOT_YET_RECRUITING","2024-10-28",{"date":34,"type":35},"2024-10-29","ACTUAL",{"date":37,"type":20},"2024-11-15",{"date":39,"type":20},"2026-11-30",{"name":41,"class":42},"Keralty SAS. Colombia","OTHER",""]