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Clinical Trials in Spain / NCT06965972
Recruiting Observational

The CohorFES: a Prospective Study of Frailty and Dependence

NCT06965972 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-12-01
Last updated
2025-05-11

Condition(s) studied

Frailty Syndrome

Study summary

Background Frailty has become a major problem for the health system, but also a window of opportunity to fight against disability through preventive strategies focused on the detection and treatment of frailty in all settings. However, no systematic strategies of screening and early detection are available in clinical settings. This project aims to identify clinical and biological phenotypic clusters that drive through the different stages of frailty and to describe the underlying mechanisms of the trajectories leading to disability and the potential for treatment. Moreover, validation of Frailty Trait Scale 5 (FTS5) will be performed as an easy model to be implemented in primary care and hospital scope.

Methods/design A prospective population-based cohort will be stablished for frailty phenotyping (CohorFES). Creation of a CIBERFES Biobank where blood and urine samples from participants of CohortFES are stored for future researches. Demographic and clinical history data, anthropometric measurements, predimed questionnaire, peripheral blood biochemical variables and metabolomics were collected for each participant at baseline and every year until become frailty.

Using cluster partition models (k-means and hierarchical clustering) will group together individuals with similar deficits and characteristics (frailty phenotypes). Then, by using pre-established criteria (gap and silhouette), the proposed clustering solution (belonging to given clusters) will be evaluated. Further, investigators will assess, in a longitudinal fashion, the appearance and accumulation of deficits during the study period and identifying the clusters subgroups with more rapid progression. Results will be applied to establish and compare clusters and trajectories. Finally, frailty phenotypes and patient clusters will be correlated with health outcomes such as the use of health services (both primary and secondary care), hospital admissions, and mortality.

Discussion Information about clinical and biological phenotypic clusters that drive through the different stages of frailty can lead to identify potential targets that could improve the therapeutic management of these patients.

In summary, from a research perspective the project aims to better understanding of the interindividual variability in clinical events that lead to frailty, dependence and finally, to death.

Eligibility

Sex
ALL
Min age
65 Years
Max age
120 Years
Healthy volunteers
Accepted
Inclusion Criteria: * women and men 65 years old or above visited in the outpatient clinics of participant centers * Signed informed consent Exclusion Criteria: * Patients in a critical situation of end of live or Barthel scale \<60.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital del Mar Research Institute Barcelona Catalonia Recruiting

More Parc de Salut Mar trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06965972 on ClinicalTrials.gov ↗ ← All trials in Spain