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

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.

Conditions

• Frailty
• Pre-Frailty

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Instituto de investigación e innovación biomédica de Cádiz

  collaborator OTHER

• University of Cadiz

  lead OTHER

Principal Investigators

• Cristina Casals, Phd, Assistant professor · University of Cadiz (SPAIN)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2027-12-15

Completion

2028-06-15

Countries

• Spain

Study Locations