In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults | NCT07738393

NCT07738393

Overview

NCT ID: NCT07738393
Lead Sponsor: University of CadizOTHER
Official Title: 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)
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Sep 15, 2026Estimated
Primary Completion Date: Dec 15, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 276Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Cristina Casals, PhDContact
cristina.casals@gm.uca.es+34 677180597

Similar Studies

Masking Description

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.

Participant Group/Arms

In-person educationExperimental

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.

Behavioral: In-person healthy aging education program

Hybrid educationExperimental

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.

Behavioral: Hybrid healthy aging education program

Online educationExperimental

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.

Behavioral: Online healthy aging education program

Usual careNo Intervention

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.