In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Cadiz
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- In-person healthy aging education program
- Hybrid healthy aging education program
- Online healthy aging education program
Treatment groups
276 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Cadiz
Lead sponsor
Instituto de investigación e innovación biomédica de Cádiz
Collaborator
Source ClinicalTrials.gov