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

Sponsor
University of Cadiz
Study ID
NCT07738393
Status
Not Yet Recruiting

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Conditions

  • Frailty
  • Pre-Frailty

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • In-person healthy aging education program — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 Details

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 Dates

First listed
Jul 31, 2026
Start date
Sep 15, 2026
Status verified
Jul 2026
Primary completion
Dec 15, 2027
Completion
Jun 15, 2028

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: In-person education
    Participants allocated to this arm will receive the in-person healthy aging educational program over 6 months. The program will include four face-to-face group sessions of approximately 1 hour each, delivered weekly during the first month. The sessions will address frailty awareness, physical activity, nutrition, cognitive and emotional well-being, and social health. During the subsequent 5 months, participants will receive six telephone follow-up calls to reinforce the educational content and support adherence to the program.
  • Experimental: Hybrid education
    Participants allocated to this arm will receive the hybrid healthy aging educational program over 6 months. The program will include four face-to-face group sessions of approximately 1 hour each, delivered weekly during the first month. The sessions will address frailty awareness, physical activity, nutrition, cognitive and emotional well-being, and social health. Participants will also receive an additional familiarization session to support access to and use of the online educational platform. During the subsequent 5 months, follow-up and reinforcement activities will be delivered through the online platform.
  • Experimental: Online education
    Participants allocated to this arm will receive the online healthy aging educational program over 6 months. Participants will first receive an in-person familiarization and setup session of approximately 1 hour to support access to and use of the online educational platform. The educational content will address frailty awareness, physical activity, nutrition, cognitive and emotional well-being, and social health. Educational content and follow-up activities will then be delivered through the platform during the 6-month intervention period.
  • No Intervention: Usual care
    Participants allocated to this arm will continue their usual healthcare and health routines and will not receive the FRAGSALUD-ON educational program during the 12-month follow-up. After completing the 12-month assessment, participants in this group will be offered access to the online educational platform, in accordance with the ethics-approved protocol.

Primary Outcome Measure

Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months [ Time Frame: Baseline and 6 months ]

Central Contacts

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