In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults
FRAGSALUD-ON
Effectiveness and Cost-Effectiveness of In-Person, Online, and Hybrid Healthy-Aging Education for Community-Dwelling Older Adults With Pre-Frailty or Frailty: A Four-Arm Randomized Controlled Trial (FRAGSALUD-ON)
2 other identifiers
interventional
276
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 31, 2026
CompletedStudy Start
First participant enrolled
September 15, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2027
Study Completion
Last participant's last visit for all outcomes
June 15, 2028
July 31, 2026
July 1, 2026
1.2 years
July 27, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Prespecified 40-Item Frailty Index Score at 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.
Baseline and 6 months
Secondary Outcomes (23)
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 months
Change From Baseline in Best Eyes-Open 30-Second Single-Leg Stance Time at 6 and 12 Months
Baseline, 6 months, and 12 months
- +18 more secondary outcomes
Other Outcomes (31)
Change From Baseline in the Individual Fried Frailty Phenotype Criteria at 6 and 12 Months
Baseline, 6 months, and 12 months
Change From Baseline in Usual-Pace 4-Meter Gait Speed at 6 and 12 Months
Baseline, 6 months, and 12 months
Change From Baseline in Five-Repetition Sit-to-Stand Completion Time at 6 and 12 Months
Baseline, 6 months, and 12 months
- +28 more other outcomes
Study Arms (4)
In-person education
EXPERIMENTALParticipants 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.
Hybrid education
EXPERIMENTALParticipants 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.
Online education
EXPERIMENTALParticipants 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.
Usual care
NO INTERVENTIONParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad de Cádiz
Puerto Real, Cádiz, 11519, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristina Casals, Phd, Assistant professor
University of Cadiz (SPAIN)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and intervention providers cannot be masked because of the nature of the educational interventions. A designated investigator with no role in sequence generation, allocation release, recruitment, baseline assessment, intervention delivery, adherence monitoring, or access to unblinded operational data will remain unaware of group allocation and will oversee blinded outcome adjudication and prespecified analytic decisions. Primary and secondary outcome assessments will be performed by trained assessors who are independent of intervention delivery and unaware of group allocation. Participants will be reminded not to disclose their assigned group during assessment visits. Any accidental unmasking of an outcome assessor will be documented. Laboratory personnel and statisticians will work with coded group labels until the analysis dataset, derivation rules, and primary model have been finalized.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 31, 2026
Study Start (Estimated)
September 15, 2026
Primary Completion (Estimated)
December 15, 2027
Study Completion (Estimated)
June 15, 2028
Last Updated
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will become available beginning 12 months after publication of the primary results, or 36 months after study completion, whichever occurs first, and will remain available for 7 years.
- Access Criteria
- Access will be considered for qualified researchers who submit a methodologically sound proposal with clearly specified aims, variables, and analyses. Requests must be approved by the Principal Investigator and comply with participant consent, ethics, and data-protection requirements. Approved requesters must sign a data-use agreement prohibiting re-identification, participant contact, onward transfer, and use outside the approved purpose; use the data through the approved secure transfer or analysis environment; cite the persistent dataset identifier; and report resulting outputs to the data provider. Additional information and instructions for submitting proposals and data-access requests are available at the IPD Sharing URL.
De-identified individual participant data underlying the results reported in peer-reviewed publications will be made available, together with a data dictionary and the analytic code needed to reproduce the reported analyses. Shared data may include clinical, functional, questionnaire, health-economic, laboratory, and derived microbiota variables, as applicable to each publication. Direct identifiers, free-text fields, exact dates, and variables or combinations of variables presenting an unacceptable re-identification risk will be removed, generalized, or withheld. Data will be prepared and shared in accordance with the informed consent, ethics approval, the General Data Protection Regulation requirements. Biological specimens will not be shared under this plan. Any sharing of raw sequencing data will follow a separate consent-, decontamination-, metadata-, and repository-specific procedure.