The CohorFES: a Prospective Study of Frailty and Dependence

NCT06965972 | Recruiting

• 1 other identifier: PI19/00033
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frailty Syndrome

Keywords

COHORFES; Frailty; FTS5

Outcome Measures

Primary Outcomes (3)

• Fried phenotype

  Frailty measure

  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

  Through study completion, an average of 5 years

• Electronic Frailty index

  Frailty measure

  Through study completion, an average of 5 years

Secondary Outcomes (19)

• Bone Mineral Density

  Through study completion, an average of 5 years

• Abnormal peripheral blood biochemistry

  Through study completion, an average of 5 years

• Age

  baseline

• Date of Birth

  baseline

• Sex

  baseline

Other Outcomes (1)

• Metabolomics

  Through study completion, an average of 5 years

Study Arms (1)

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

To stablish the CohorFES, a prospective and observational study based on real population. Patients are recruited from the beginning of the project and followed year on year during all the study time. Individuals visited in participant centers and meet inclusion criteria are asked to participate into the study. These individuals are consecutively included to the study after signed the informed consent.

Eligibility Criteria

• Age: 65 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• CIBER on frailty and healthy ageing: collaborator

Study Sites (1)

Hospital del Mar Research Institute

Barcelona, Catalonia, 08003, Spain

RECRUITING

Related Publications (15)

• Stow D, Matthews FE, Barclay S, Iliffe S, Clegg A, De Biase S, Robinson L, Hanratty B. Evaluating frailty scores to predict mortality in older adults using data from population based electronic health records: case control study. Age Ageing. 2018 Jul 1;47(4):564-569. doi: 10.1093/ageing/afy022.

  PMID: 29546362 RESULT

• Gilbert T, Neuburger J, Kraindler J, Keeble E, Smith P, Ariti C, Arora S, Street A, Parker S, Roberts HC, Bardsley M, Conroy S. Development and validation of a Hospital Frailty Risk Score focusing on older people in acute care settings using electronic hospital records: an observational study. Lancet. 2018 May 5;391(10132):1775-1782. doi: 10.1016/S0140-6736(18)30668-8. Epub 2018 Apr 26.

  PMID: 29706364 RESULT

• Clegg A, Bates C, Young J, Ryan R, Nichols L, Teale EA, Mohammed MA, Parry J, Marshall T. Development and validation of an electronic frailty index using routine primary care electronic health record data. Age Ageing. 2018 Mar 1;47(2):319. doi: 10.1093/ageing/afx001. No abstract available.

  PMID: 28100452 RESULT

• Garcia-Garcia FJ, Carnicero JA, Losa-Reyna J, Alfaro-Acha A, Castillo-Gallego C, Rosado-Artalejo C, Gutierrrez-Avila G, Rodriguez-Manas L. Frailty Trait Scale-Short Form: A Frailty Instrument for Clinical Practice. J Am Med Dir Assoc. 2020 Sep;21(9):1260-1266.e2. doi: 10.1016/j.jamda.2019.12.008. Epub 2020 Jan 29.

  PMID: 32005416 RESULT

• Checa-Lopez M, Oviedo-Briones M, Pardo-Gomez A, Gonzales-Turin J, Guevara-Guevara T, Carnicero JA, Alamo-Ascencio S, Landi F, Cesari M, Grodzicki T, Rodriguez-Manas L; FRAILTOOLS consortium. FRAILTOOLS study protocol: a comprehensive validation of frailty assessment tools to screen and diagnose frailty in different clinical and social settings and to provide instruments for integrated care in older adults. BMC Geriatr. 2019 Mar 18;19(1):86. doi: 10.1186/s12877-019-1042-1.

  PMID: 30885132 RESULT

• Garcia-Garcia FJ, Carcaillon L, Fernandez-Tresguerres J, Alfaro A, Larrion JL, Castillo C, Rodriguez-Manas L. A new operational definition of frailty: the Frailty Trait Scale. J Am Med Dir Assoc. 2014 May;15(5):371.e7-371.e13. doi: 10.1016/j.jamda.2014.01.004. Epub 2014 Mar 2.

  PMID: 24598478 RESULT

• Gill TM, Gahbauer EA, Han L, Allore HG. The relationship between intervening hospitalizations and transitions between frailty states. J Gerontol A Biol Sci Med Sci. 2011 Nov;66(11):1238-43. doi: 10.1093/gerona/glr142. Epub 2011 Aug 17.

  PMID: 21852286 RESULT

• Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci. 2007 Jul;62(7):722-7. doi: 10.1093/gerona/62.7.722.

  PMID: 17634318 RESULT

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 RESULT

• Rodriguez-Manas L, Rodriguez-Artalejo F, Sinclair AJ. The Third Transition: The Clinical Evolution Oriented to the Contemporary Older Patient. J Am Med Dir Assoc. 2017 Jan;18(1):8-9. doi: 10.1016/j.jamda.2016.10.005. Epub 2016 Nov 22. No abstract available.

  PMID: 27887892 RESULT

• Rodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.

  PMID: 25468154 RESULT

• Sirven N, Rapp T. The cost of frailty in France. Eur J Health Econ. 2017 Mar;18(2):243-253. doi: 10.1007/s10198-016-0772-7. Epub 2016 Feb 25.

  PMID: 26914932 RESULT

• Trombetti A, Hars M, Hsu FC, Reid KF, Church TS, Gill TM, King AC, Liu CK, Manini TM, McDermott MM, Newman AB, Rejeski WJ, Guralnik JM, Pahor M, Fielding RA; LIFE Study Investigators. Effect of Physical Activity on Frailty: Secondary Analysis of a Randomized Controlled Trial. Ann Intern Med. 2018 Mar 6;168(5):309-316. doi: 10.7326/M16-2011. Epub 2018 Jan 9.

  PMID: 29310138 RESULT

• Rodriguez-Manas L, Feart C, Mann G, Vina J, Chatterji S, Chodzko-Zajko W, Gonzalez-Colaco Harmand M, Bergman H, Carcaillon L, Nicholson C, Scuteri A, Sinclair A, Pelaez M, Van der Cammen T, Beland F, Bickenbach J, Delamarche P, Ferrucci L, Fried LP, Gutierrez-Robledo LM, Rockwood K, Rodriguez Artalejo F, Serviddio G, Vega E; FOD-CC group (Appendix 1). Searching for an operational definition of frailty: a Delphi method based consensus statement: the frailty operative definition-consensus conference project. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):62-7. doi: 10.1093/gerona/gls119. Epub 2012 Apr 16.

  PMID: 22511289 RESULT

• Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.

  PMID: 23764209 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

SERUM, PLASMA, URINE

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier Nogues, PhD

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Garcia-Giralt, PhD

CONTACT

00346160497; ngarcia@researchmar.net

Diana Ovejero, PhD

CONTACT

0034933160497; dovejero@researchmar.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 11, 2025
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: from 1/1/2035 to 31/12/2050
• Access Criteria: All researcher can request to the Hospital del Mar Research Institute the anomyzed IPD from 1/1/2035

Locations

ES (1)