In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults

Starting soon · Not applicable

Conditions studied: Frailty, Pre-Frailty

In brief

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.

Key facts

Study ID: NCT07738393
Run by: University of Cadiz
People needed: 276
Starts: 2026-09-15
Expected to finish: 2028-06-15
Last updated by the study team: 2026-07-31

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Community-dwelling adults aged 65 years or older.
Presence of pre-frailty or frailty according to the prespecified operationalization of the Fried frailty phenotype, defined as meeting at least one of the five Fried criteria (pre-frailty: 1-2 criteria; frailty: 3-5 criteria).
Ability to understand spoken and written Spanish sufficiently to follow the intervention and study procedures.
Access at home to Wi-Fi or mobile data and to a smartphone, tablet, or computer capable of connecting to the internet.
Ability to attend the study assessments and, if randomized to the in-person or hybrid intervention, the scheduled face-to-face sessions.
Ability to understand the study information and provide written informed consent.

You may not qualify if…

Permanent residence in a nursing home or other long-term residential care institution.
Robust status according to the Fried frailty phenotype, defined as meeting none of the five Fried criteria.
Severe dementia or any cognitive, neurological, or psychiatric condition that precludes valid informed consent or the ability to understand and follow the study procedures.
Use of systemic antibiotics during the 3 months preceding baseline stool-sample collection.
Known terminal illness or receipt of end-of-life care, with an anticipated life expectancy of less than 12 months, based on available clinical documentation or assessment by a qualified clinician.
Current participation in another interventional study involving an investigational medicinal product or a structured physical activity, nutritional, cognitive, or social intervention that overlaps with the FRAGSALUD-ON intervention or follow-up period.

Where it is running

Universidad de Cádiz — Puerto Real, Cádiz, Spain

Full record on ClinicalTrials.gov

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