The CohorFES: a Prospective Study of Frailty and Dependence

ConditionFrailty Syndrome

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age65-120

SponsorParc de Salut Mar

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

women and men 65 years old or above visited in the outpatient clinics of participant centers

Signed informed consent

Disqualifiers

Patients in a critical situation of end of live or Barthel scale <60.

Trial population

Participants are women and men 65 years old or above visited in the outpatient clinics of participant centers: Hospital General Universitario Gregorio Marañón, Madrid Hospital Universitario de Getafe, Madrid Hospital General Universitario de Ciudad Real, Ciudad real Hospital del Mar, Consorci Mar Parc Salut de Barcelona, Barcelona Complejo Hospitalario Universitario de Albacete, Albacete Fundación del Hospital Nacional de Parapléjicos, Toledo These participants are included in the COHORFES

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants

are grouped into 1 trial group

Group A: women and men 65 years old or above visited in the outpatient clinics of participant centers

Trial outcomes

Primary outcomes

Fried phenotype

Frailty measure

Time frame

Through study completion, an average of 5 years

Frailty Trait Scale 5 ítems: 1.- walking speed test, 2.- grip strength, 3.- Physical Activity, 4- Body Mass Index (BMI), 5.- progressive Romberg test. Point 1 to 5 are combined to report the frailty trait scale

Frailty measure

Time frame

Through study completion, an average of 5 years

Electronic Frailty index

Frailty measure

Time frame

Through study completion, an average of 5 years

Secondary outcomes

Bone Mineral Density

Bone Mineral Density measured using a Dual-Energy X-Ray Analysis (DXA) device (Hologic Horizon Wi, Hologic®).

Time frame

Through study completion, an average of 5 years

Abnormal peripheral blood biochemistry

Detection of anormal values of the following parameters (y/n): * Leukocytes ml/mmc * Red blood cells ml/mmc * Hemoglobin g/dl * Hematocrit % * Red blood cell distribution width % * Platelets ml/mmc * Vitamin D ng/ml * TSH nmol/l * Glucose mg/dl * Glycated hemoglobin (diabetics only) % * Creatinine mg/dl * Sodium meq/dl * Potassium meq/dl * Calcium mg/dl * Phosphorus mg/dl * GPT u/l * GOT u/l * Phosphatase alkaline u/l * Total proteins g/dl * Albumin g/dl * Prealbumin mg/dl * Cholesterol mg/dl * Triglycerides mg/dl * HDL mg/dl * LDL mg/dl * C-reactive protein mg/ml These parameters are combined with the final outcome: abnormal biochemistry (y/n)

Time frame

Through study completion, an average of 5 years

Age

Age in years

Time frame

baseline

Date of Birth

Date (dd/mm/yyyy)

Time frame

baseline

Other outcomes

Metabolomics

Quantitative metabolomics approach applied to analyze plasma samples using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). It is defined as altered metaboloma (y/n)

Time frame

Through study completion, an average of 5 years

Sponsors and contacts

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Parc de Salut Mar

Lead sponsor

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Collaborator

CIBER on frailty and healthy ageing

Collaborator

Source ClinicalTrials.gov

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