Clinical trial NCT02637518: Comprehensive Validation of Frailty Assessment Tools in Older Adults in Different Clinical and Social Settings
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syndrome
Keywords: Frailty
Frailty screening tools
Clinical settings
Social settings
Geriatrics
Functional autonomy
Disability
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2015-12-22
Enrollment: 1940
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People older than 75 years old will be included, recruited from different clinical settings such as clinical (hospital or primary care) and social (nursing homes).

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.

Detailed description: Quality assurance plan:

According to the European's Commission guidelines, the procedure for quality control focuses on the deliverables revision and in the quality of each procedure. The deliverables will be sent to the Administrative committee. The administrative Committee, composed by the Project's Promoter and its associates, will assume the role as a quality manager. It includes the following tasks:

Making sure of the monitoring of all of the changes in documentation. Making sure the activity's coordination and reports are completed according to an adequate quality and in an appropriate manner.

Reviewing the contract deliverables. Monitoring and auditing the project's activities according to plan, making the specific revisions of the contractual deliverables, directed to the achievement of the established objectives.

The electronic Case Report Form (eCRF) has been designed to capture all data required in the protocol. A unique eCRF will be completed for subject, taking into account the protection law in each country of the study.Subjects will be identified by a unique subject number (with key held by the relevant partner), so none identification card number will be recorded on the eCRF or the database. The monitor will guarantee that the eCRF is fully and correctly fill up according to the source documents. The researcher will assure that all data recorded in the eCRF coincide with the information recorded in the source documents.

Plan for missing data to address situations where variables are reported as missing:

The investigators will check the missing data in each eCRF and source documents.

Statistical analysis:

Investigator will assess the associations of each scale with the outcome for each setting and outcome through logistic regressions. First, investigators will compute the classification performance (sensitivity, specificity, Receptors Operational Curve (ROC), Area Under the Curve (AUC), predictive values, likelihood ratios) for each model. Second, investigators will study the feasibility of the models taking into account the time needed for the scale and the percentage of patients that can be assessed per case. Investigators will evaluate the sensitivity to change of the scales and the covariance of the scales with other measures as the SPPB through a mixed linear model.

Sample Size: Participants will be recruited in Spain, Italy, France, United Kingdom and Poland. The total sample will be of 1.940 subjects. Each participating centre will have to recruit a total of 388 patients, corresponding to 97 subjects in each clinical setting by centre.

Eligibility criteria: Inclusion Criteria:

* People older than 75 years old, who sign the informed consent after accepting their participation.

Exclusion Criteria:

* General exclusion criteria will be an MMSE score less than 20 points or having a terminal illness (life expectancy \< 6 months).
* Subjects included from the hospital ward (Acute Geriatric Unit and Outpatient
* Geriatric Consultation) and primary care will have additional exclusion criteria: dependency in more than 2 Instrumental Activities of Daily Living (IADL) in women (Lawton \< 6), and in more than 3 IADL in men (Lawton \< 5).
* Subjects seen in a nursing home setting will be excluded if they obtain less than 40 points in the Barthel index.

Primary outcomes:
measure: Mortality
timeFrame: 18 months
measure: Functional disability
timeFrame: 18 months
measure: Disability to perform IADL
timeFrame: 18 months
measure: Disability to perform BADL
timeFrame: 18 months
measure: Falls
timeFrame: 18 months
measure: Incident cognitive impairment
timeFrame: 18 months
Secondary outcomes:
measure: Frailty classification performance
timeFrame: 18 months
measure: Tool feasibility
timeFrame: 18 months
measure: Sensitivity to change in frailty status
timeFrame: 18 months
measure: Qualification as a screening and/or diagnosis tool
timeFrame: 18 months
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
Study officials:
affiliation: HOSPITAL UNIVERSITARIO DE GETAFE
name: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Rodriguez-Manas L, Sinclair AJ. Frailty: the quest for new domains, clinical definitions and subtypes. Is this justified on new evidence emerging? J Nutr Health Aging. 2014 Jan;18(1):92-4. doi: 10.1007/s12603-013-0433-9. No abstract available.
citation: 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.
citation: Gill TM, Gahbauer EA, Allore HG, Han L. Transitions between frailty states among community-living older persons. Arch Intern Med. 2006 Feb 27;166(4):418-23. doi: 10.1001/archinte.166.4.418.
citation: Fried LP, Guralnik JM. Disability in older adults: evidence regarding significance, etiology, and risk. J Am Geriatr Soc. 1997 Jan;45(1):92-100. doi: 10.1111/j.1532-5415.1997.tb00986.x.
citation: Oviedo-Briones M, Rodriguez-Laso A, Carnicero JA, Gryglewska B, Sinclair AJ, Landi F, Vellas B, Rodriguez Artalejo F, Checa-Lopez M, Rodriguez-Manas L. The ability of eight frailty instruments to identify adverse outcomes across different settings: the FRAILTOOLS project. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1487-1501. doi: 10.1002/jcsm.12990. Epub 2022 Apr 15.
citation: 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.