In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults (NCT07738393) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
In-Person, Online, and Hybrid Healthy-Aging Education for Pre-Frailty and Frailty in Older Adults
Spain276 participantsStarted 2026-09-15
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in the Prespecified 40-Item Frailty Index Score at 6 Months