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Clinical Trials in Spain / NCT07738393
Starting soon Not applicable

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

NCT07738393 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Cadiz
Phase
Not applicable
Started
2026-09-15
Last updated
2026-07-31

Condition(s) studied

FrailtyPre-Frailty

Investigational drug(s) / intervention(s)

In-person healthy aging education programHybrid healthy aging education programOnline healthy aging education program

In-person healthy aging education program: A 6-month healthy aging educational program delivered face to face. The program includes four weekly group sessions of approximately 1 hour during the first month, followed by six telephone follow-up calls during the subsequent 5 months. Educational content addresses frailty awareness, physical activity, nutrition, cognitive and emotional well-being, and social health. Educational materials were developed before participant recruitment with artificial-intelligence assistance and were reviewed, edited, and approved by the research team before use. Telephone follow-up is used to reinforce the educational content, address participant questions, and support adherence to healthy lifestyle recommendations.

Hybrid healthy aging education program: A 6-month healthy aging educational program combining face-to-face sessions and online follow-up. The program includes four weekly group sessions of approximately 1 hour during the first month. Educational content addresses frailty awareness, physical activity, nutrition, cognitive and emotional well-being, and social health. Participants also receive a familiarization session to support access to and use of the online educational platform. During the subsequent 5 months, reinforcement and follow-up activities are delivered through the platform. Educational materials were developed before participant recruitment with artificial-intelligence assistance and were reviewed, edited, and approved by the research team before use.

Online healthy aging education program: A 6-month healthy aging educational program delivered through an online educational platform. Participants first receive an in-person familiarization and setup session of approximately 1 hour to support access to and use of the platform. Educational content addresses frailty awareness, physical activity, nutrition, cognitive and emotional well-being, and social health. During the intervention period, educational content and follow-up activities are delivered through the platform. Educational materials were developed before participant recruitment with artificial-intelligence assistance and were reviewed, edited, and approved by the research team before use.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months — Baseline and 6 months
    A prespecified 40-item deficit-accumulation Frailty Index (40-FI) will be calculated as the sum of observed deficit scores divided by the number of evaluable deficits. The 40-FI ranges from 0 to 1, with higher values indicating greater frailty. A score will be calculated when at least 32 of the 40 deficits (80%) are evaluable. Change will be calculated as the 6-month score minus the baseline score; negative values indicate improvement. The fixed item list, item-level coding rules, permitted intermediate values, denominator, and missing-data rules are defined in the version-controlled 40-FI Specification included as an annex to Protocol and SAP and finalized before enrolment of the first participant.

Trial sites (1)

FacilityCityRegionStatus
Universidad de Cádiz Puerto Real Cádiz

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07738393 on ClinicalTrials.gov ↗ ← All trials in Spain