{"type":"trials","record":{"id":499,"source_id":"clinicaltrials-gov","external_id":"NCT07738393","title":"In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults","brief_summary":"The goal of this clinical trial is to determine whether a 6-month healthy-aging education program delivered in person, online, or in a hybrid format reduces frailty and is cost-effective compared with usual care in community-dwelling adults aged 65 years or older with pre-frailty or frailty. The main questions are: * Do the three educational programs, considered together, reduce the prespecified 40-item Frailty Index (40-FI) at 6 months more than usual care? * Are effects maintained 6 months after the programs end? * How do the in-person, online, and hybrid educational programs differ in multidomain frailty outcomes, implementation, costs, and quality-adjusted life-years? * Are changes in prespecified blood biomarkers and gut microbiota associated with changes in frailty and related outcomes? The study will enroll 276 participants. Randomization will occur at household level so that enrolled cohabitants receive the same assignment. Households will be allocated to in-person education, online education, hybrid education, or usual care. All three educational programs address physical activity, nutrition, cognitive and emotional well-being, and social connection. Assessments will occur at baseline, 6 months, and 12 months; blood and stool samples will be collected at baseline and 6 months. The trial will compare the average effect of the three active programs with usual care and will estimate modality-specific clinical and economic outcomes.","overall_status":"Not Yet Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Cadiz","enrollment":276,"countries":["Spain"],"start_date":"2026-09-15","completion_date":"2028-06-15","last_update_date":"2026-07-31","source_url":"https://clinicaltrials.gov/study/NCT07738393","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T02:45:05.518263+00:00","last_seen_at":"2026-09-25T06:25:45.678+00:00","metadata":{"sex":"ALL","acronym":"FRAGSALUD-ON","age_range":"65 Years","comparator":"Usual care","organization":"University of Cadiz","interventions":["In-person healthy aging education program","Hybrid healthy aging education program","Online healthy aging education program"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months — Baseline and 6 months","Change From Baseline in the Prespecified 40-Item Frailty Index Score at 12 Months — Baseline and 12 months","Change From Baseline in the Fried Frailty Phenotype Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Maximum Dominant-Hand Grip Strength at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Short Physical Performance Battery Total Score at 6 and 12 Months — Baseline, 6 months, and 12…","Change From Baseline in Best Eyes-Open 30-Second Single-Leg Stance Time at 6 and 12 Months — Baseline, 6 months, and 12…","Change From Baseline in Fast-Pace 4-Meter Gait Speed at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Estimated Relative Sit-to-Stand Mean Power at 6 and 12 Months — Baseline, 6 months, and 12 mont…","Change From Baseline in Barthel Index Total Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Lawton Instrumental Activities of Daily Living Total Score at 6 and 12 Months — Baseline, 6 mon…","Change From Baseline in Accelerometer-Measured Moderate-to-Vigorous Physical Activity at 6 and 12 Months — Baseline, 6…","Change From Baseline in Full Mini Nutritional Assessment Total Score at 6 and 12 Months — Baseline, 6 months, and 12 mo…","Change From Baseline in Montreal Cognitive Assessment Total Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Pittsburgh Sleep Quality Index Global Score at 6 and 12 Months — Baseline, 6 months, and 12 mon…","Change From Baseline in Depressive Symptoms Assessed With the 15-Item Geriatric Depression Scale at 6 and 12 Months — B…","Change From Baseline in EQ-5D-5L Index Value at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in EQ Visual Analogue Scale Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Rate of Falls During the 12-Month Follow-up — From randomization through 12 months","Change From Baseline in Perceived Functional Social Support Assessed With the Duke-UNC-11 at 6 and 12 Months — Baseline…","Total Societal Cost per Participant Over 12 Months — From baseline through 12 months"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":false},"controlled_terms":["Frailty","Pre-Frailty","In-person healthy aging education program","Hybrid healthy aging education program","Online healthy aging education program"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:25:48.368501+00:00","duplicate_cluster_key":"id:nct07738393","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-09-15 to 2028-06-15","comparator":"Usual care","confidence":"structured-source","population":"ALL · 65 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":"2026-09-25T06:25:45.684Z","intervention":["In-person healthy aging education program","Hybrid healthy aging education program","Online healthy aging education program"],"participants":276,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","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":["Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months — Baseline and 6 months","Change From Baseline in the Prespecified 40-Item Frailty Index Score at 12 Months — Baseline and 12 months","Change From Baseline in the Fried Frailty Phenotype Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Maximum Dominant-Hand Grip Strength at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Short Physical Performance Battery Total Score at 6 and 12 Months — Baseline, 6 months, and 12…","Change From Baseline in Best Eyes-Open 30-Second Single-Leg Stance Time at 6 and 12 Months — Baseline, 6 months, and 12…","Change From Baseline in Fast-Pace 4-Meter Gait Speed at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Estimated Relative Sit-to-Stand Mean Power at 6 and 12 Months — Baseline, 6 months, and 12 mont…","Change From Baseline in Barthel Index Total Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Lawton Instrumental Activities of Daily Living Total Score at 6 and 12 Months — Baseline, 6 mon…","Change From Baseline in Accelerometer-Measured Moderate-to-Vigorous Physical Activity at 6 and 12 Months — Baseline, 6…","Change From Baseline in Full Mini Nutritional Assessment Total Score at 6 and 12 Months — Baseline, 6 months, and 12 mo…","Change From Baseline in Montreal Cognitive Assessment Total Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in Pittsburgh Sleep Quality Index Global Score at 6 and 12 Months — Baseline, 6 months, and 12 mon…","Change From Baseline in Depressive Symptoms Assessed With the 15-Item Geriatric Depression Scale at 6 and 12 Months — B…","Change From Baseline in EQ-5D-5L Index Value at 6 and 12 Months — Baseline, 6 months, and 12 months","Change From Baseline in EQ Visual Analogue Scale Score at 6 and 12 Months — Baseline, 6 months, and 12 months","Rate of Falls During the 12-Month Follow-up — From randomization through 12 months","Change From Baseline in Perceived Functional Social Support Assessed With the Duke-UNC-11 at 6 and 12 Months — Baseline…","Total Societal Cost per Participant Over 12 Months — From baseline through 12 months"],"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, frailty index.","Source terminology contains: frailty.","Title supplies longevity context: aging, frailty.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","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/499","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}