{"type":"trials","record":{"id":5454,"source_id":"clinicaltrials-gov","external_id":"NCT06663150","title":"Effectiveness of a Socio-Community Health Intervention on Pre-Frailty in Older Adults","brief_summary":"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. Specific Objectives: To characterize the study population according to sociodemographic and clinical variables. To evaluate the effect of the intervention on the functionality domain at 3 and 6 months. To evaluate the effect of the intervention on the cognitive-emotional domain at 3 and 6 months. To evaluate the effect of the intervention on the socio-community domain at 3 and 6 months. To evaluate the effect of the intervention on frailty in older adults. To determine the proportion of participants hospitalized during the study period. To determine the proportion of participants who visited the emergency room during the study period. To determine the proportion of participants in long-term care facilities. To determine the proportion of adverse events associated with the intervention. Study Hypothesis The mean frailty score pre-intervention is equal to the mean frailty score post-intervention. The mean frailty score pre-intervention is different from the mean frailty score post-intervention.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Keralty SAS. Colombia","enrollment":160,"countries":["Colombia"],"start_date":"2025-03-25","completion_date":"2026-06-26","last_update_date":"2026-09-16","source_url":"https://clinicaltrials.gov/study/NCT06663150","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-16T12:17:06.74576+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years","comparator":"Control group","organization":"Keralty SAS. Colombia","interventions":["health intervention with a socio-community approach"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Score on the FRAIL Scale — Baseline, 3, 6 Months","Barthel Index — Baseline, 3, 6 Months","Lawton Score — Baseline, 3, 6 Months","Downton Scale — Baseline, 3, 6 Months","Score on the Montreal Cognitive Assessment (MoCA) — Baseline, 3, 6 Months","Score on the Yesavage Geriatric Depression Scale (GDS) — Baseline, 3, 6 Months","Score on the Gijón Family-Social Assessment Scale — Baseline, 3, 6 Months","Score on the Lubben Social Network Scale — Baseline, 3, 6 Months","Health-Related Quality of Life Measured by EQ-5D-3L — Baseline, 3, 6 Months","Number of Hospital Admissions — During the 6-month intervention","Total Number of Hospitalization Days — During the 6-month intervention","Total Number of Emergency Room Admissions — During the 6-month intervention.","Requirement for Admission to Long-Term Care Facilities — During the 6-month intervention.","Utilization of Social Health Assets — During the 6-month intervention."],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","source_has_results":false},"controlled_terms":["Frail Elderly Syndrome","health intervention with a socio-community approach"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct06663150","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-03-25 to 2026-06-26","comparator":"Control group","confidence":"structured-source","population":"ALL · 60 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.384Z","intervention":["health intervention with a socio-community approach"],"participants":160,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Score on the FRAIL Scale — Baseline, 3, 6 Months","Barthel Index — Baseline, 3, 6 Months","Lawton Score — Baseline, 3, 6 Months","Downton Scale — Baseline, 3, 6 Months","Score on the Montreal Cognitive Assessment (MoCA) — Baseline, 3, 6 Months","Score on the Yesavage Geriatric Depression Scale (GDS) — Baseline, 3, 6 Months","Score on the Gijón Family-Social Assessment Scale — Baseline, 3, 6 Months","Score on the Lubben Social Network Scale — Baseline, 3, 6 Months","Health-Related Quality of Life Measured by EQ-5D-3L — Baseline, 3, 6 Months","Number of Hospital Admissions — During the 6-month intervention","Total Number of Hospitalization Days — During the 6-month intervention","Total Number of Emergency Room Admissions — During the 6-month intervention.","Requirement for Admission to Long-Term Care Facilities — During the 6-month intervention.","Utilization of Social Health Assets — During the 6-month intervention."],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/5454","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}