NCT02637518|UnknownDMC

Comprehensive Validation of Frailty Assessment Tools in Older Adults in Different Clinical and Social Settings

FRAILTOOLS

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.

Hospital Universitario Getafe ClinicalTrials.gov

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1 other identifier

662887

Study Type

observational

Target

1,940

Locations

1 country

Sites

Timeline

RegisteredDec 2015

StartedMay 2015

CompletionMay 2018

Brief Summary

There is a proved strong evidence of the usefulness of frailty as a predictive factor of relevant and desired outcomes in populations of older adults. Several studies have been published showing the utility of the concept in improving the prognosis accuracy and the prediction of different risks (hospitalisations, surgical and non surgical complications, length of stay, death, incident disability, etc.) in emergency departments, surgical patients, and inpatients with cardiovascular disease. The studies have placed the focus in assessing population risk, while the validation process for these instruments as diagnosis or screening tools has been usually neglected. FRAILTOOLS aims to assess the usefulness as screening and diagnosis tools of some selected instruments to detect frailty in both clinical (Hospital and Primary Care) and social (Nursing Homes) settings, providing diagnostic algorithms clinically sound. Target groups are all of those older adults at risk of frailty (pre-frail) plus those that are frail and are at risk for developing disability. According to the published prevalence of these two conditions, the target population concerned by this project represents around 40-50% of people older than 65, and 60-70% of people older than 75. Once determining the best tools of screening and diagnosis in different settings of care, investigators will research conclusions of these people wherever the level of care they need and currently use. The benefit will spend to the Health System and Social Care as it will provide validated instruments that are necessary to provide an appropriate care for older adults by means of a comprehensive, continued, coordinated and integrated care.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

1,940

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2015

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

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

3 years study duration

Study Start

First participant enrolled

May 1, 2015

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed

Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

December 16, 2015

Last Update Submit

August 23, 2016

Conditions

Syndrome

Keywords

FrailtyFrailty screening toolsClinical settingsSocial settingsGeriatricsFunctional autonomyDisability

Outcome Measures

Primary Outcomes (6)

Mortality
data obtained from the official registration of the country of the corresponding partner. When not available, other methods will be used (asking to a proxy, calls to nursing homes, medical registries, etc.).
18 months
Functional disability
Defined as a loss of at least one point in the Short Physical Performance Battery (SPPB).
18 months
Disability to perform IADL
Defined as a loss of at least one point in the Lawton Index
18 months
Disability to perform BADL
Defined as a loss of at least one point in the Barthel Index.
18 months
Falls
Data will be collected by the participant's verbal recall (self-assessed) and will be registered in the electronic Case Report Form (eCRF).
18 months
Incident cognitive impairment
Defined by a reduction of 2 or more points in the Mini-Mental State Examination (MMSE).
18 months

Secondary Outcomes (4)

Frailty classification performance
18 months
Tool feasibility
18 months
Sensitivity to change in frailty status
18 months
Qualification as a screening and/or diagnosis tool
18 months

Study Arms (5)

Hospital Universitario de Getafe

Assessment of frailty tools in elderly people The Geriatric Department attends patients: 1800/year - acute unit. 800/year - Orthogeriatrics and Interconsultation Unit. 300/year - Day Hospital. 4000/year - Outpatient office. 1200/year - Domiciliary Care.