NCT02643069

Brief Summary

Frailty is the main risk factor for the development of incident disability in older people and one of the most important for other adverse outcomes (death, hospitalisation, falls, and permanent institutionalisation). Although frailty is a frequent condition in older adults who attend hospitals, little is known about its true prevalence in different settings of care. Better knowledge of this issue will inform the rational design of more effective strategies aimed at providing fitted care for these patients. Thus, the current study will potentially have impact on the quality of care for frail patients by revealing the prevalence of frailty in different settings of care, the difficulties in detection and management of frailty in these settings and the best instruments to detect frailty. The investigators proposal brings together 6 partners in the European Union (EU) from three countries, with the common aim of studying the feasibility of a program to detect frail older patients in high risk clinical settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
821

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

7.1 years

First QC Date

March 26, 2015

Last Update Submit

September 8, 2023

Conditions

Frailty Syndrome

Keywords

FrailtyFrailty toolsClinical settingsDisabilityQuality of lifeFunctional Autonomy

Outcome Measures

Primary Outcomes (4)

  • Functional Status assessed using the Barthel index for Basic Activities of Daily Living

    will be assessed using the Barthel index for Basic Activities of Daily Living

    36 months

  • Functional Status assessed using the Lawton index for Instrumental Activities of Daily Living

    will be assessed using the Lawton index for Instrumental Activities of Daily Living

    36 months

  • Institutionalization (defined as the number of patients newly addressed to nursing)

    defined as the number of patients newly addressed to nursing

    36 months

  • Mortality

    number of deaths occurred either during hospitalization or at follow-up

    36 months

Study Arms (2)

Intervention Geriatric Program

EXPERIMENTAL

A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, according to the treating physicians (s) surgeon and the performance of a geriatrician . This management will consist of the therapeutic plan, access to geriatric levels of care, coordination with primary and social care, rehabilitation, and discharge plan.

Other: Intervention Geriatric Program

Usual clinical practice

NO INTERVENTION

A comprehensive management plan of the frail patients, covering both in-hospital and postdischarge time, agreed with the treating physicians (s) surgeon.

Interventions

Intervention Geriatric ProgramOTHER

The investigators will implemented programs to detected and manage care for older patients in four settings: Emergency room, oncology department, surgery departments making major surgery and Cardiology. The core intervention will consist of the following elements: comprehensive geriatric assessment, coordination with primary ans social care, integrated and continued care, access to rehabilitation facilities, management of drug treatment avoiding polypharmacy and stressing adherence.

Intervention Geriatric Program

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Frailty patients older than 75 years old attended in the settings of care.
  • Willing and able to provide informed consent

You may not qualify if:

  • Lack of capacity to give informed consent.
  • Those unable or unwilling to cooperate with any of the assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopsital Universitario de Getafe

Getafe, Madrid, 28905, Spain

Location

Related Publications (7)

  • 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: 25468154BACKGROUND

  • Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.

    PMID: 16129869BACKGROUND

  • 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: 11253156RESULT

  • Pena FG, Theou O, Wallace L, Brothers TD, Gill TM, Gahbauer EA, Kirkland S, Mitnitski A, Rockwood K. Comparison of alternate scoring of variables on the performance of the frailty index. BMC Geriatr. 2014 Feb 24;14:25. doi: 10.1186/1471-2318-14-25.

    PMID: 24559204RESULT

  • Drubbel I, Numans ME, Kranenburg G, Bleijenberg N, de Wit NJ, Schuurmans MJ. Screening for frailty in primary care: a systematic review of the psychometric properties of the frailty index in community-dwelling older people. BMC Geriatr. 2014 Mar 6;14:27. doi: 10.1186/1471-2318-14-27.

    PMID: 24597624RESULT

  • Theou O, Brothers TD, Mitnitski A, Rockwood K. Operationalization of frailty using eight commonly used scales and comparison of their ability to predict all-cause mortality. J Am Geriatr Soc. 2013 Sep;61(9):1537-51. doi: 10.1111/jgs.12420. Epub 2013 Aug 26.

    PMID: 24028357RESULT

  • Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.

    PMID: 22836700RESULT

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leocadio Rodriguez Mañas, IP

    Hospital Universitario de Getafe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2015

First Posted

December 30, 2015

Study Start

February 1, 2014

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

ES(1)