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

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.

Sponsors

Lead Sponsor: Hospital Universitario Getafe

Collaborator: European Commission

Source Hospital Universitario Getafe
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.

Overall Status Unknown status
Start Date 2015-05-01
Completion Date 2018-05-01
Primary Completion Date 2016-08-01
Study Type Observational
Primary Outcome
Measure Time Frame
Mortality 18 months
Functional disability 18 months
Disability to perform IADL 18 months
Disability to perform BADL 18 months
Falls 18 months
Incident cognitive impairment 18 months
Secondary Outcome
Measure Time Frame
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
Enrollment 1940
Condition
Intervention

Intervention Type: Other

Intervention Name: Assessment of frailty tools in elderly people

Description: Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)

Eligibility

Sampling Method:

Non-Probability Sample

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.

Gender:

All

Minimum Age:

75 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
LEOCADIO RODRIGUEZ MAÑAS, MD, PhD Principal Investigator HOSPITAL UNIVERSITARIO DE GETAFE
Overall Contact

Last Name: LEOCADIO RODRIGUEZ MAÑAS, MD, PhD

Phone: +34 916839360

Phone Ext.: 2760

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Hospital Universitario de Getafe LEOCADIO RODRIGUEZ MAÑAS, MD, PhD +34916839360 2760 [email protected]
Location Countries

Spain

Verification Date

2016-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Hospital Universitario de Getafe

Description: 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.

Label: Diabetes Frail Ltd.

Description: Assessment of frailty tools in elderly people Has significant experience in managing research studies in older people.

Label: Università Cattólica del Sacro Cuore

Description: Assessment of frailty tools in elderly people The Geriatric Unit is compounded by: 24 beds of Acute Care Ward 46 beds of Intensive Rehabilitation Unit 20 beds of Day Hospital Outpatient clinic

Label: Gérontopole de Toulouse

Description: Assessment of frailty tools in elderly people The Geriatric Unit is compounded by: 5 Acute Care Units - 100 beds. 3 Rehabilitation Unit - 75 beds. Long term care Unit - 140 beds. 2 Day Hospitals Outpatient Clinic

Label: Jagiellonian University Medical College

Description: Assessment of frailty tools in elderly people The Department of Internal Medicine and Gerontology is the largest centre in Poland limited to the Geriatric market.

Acronym FRAILTOOLS
Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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