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.

Background: Dozens of scales and questionnaires have been used in the detection of frailty; however, a generalized method for its screening and diagnosis is still lacking in clinical settings. FRAILTOOLS´ main objective is to evaluate the usefulness of frailty scales in the detection of frailty in different clinical and social settings, and its integration in management algorithms for the frail older patient.

Methods: FRAILTOOLS is an observational, longitudinal and prospective study with a follow-up of 6, 12 and 18 months. People older than 75 years old will be recruited from three separate clinical settings (acute geriatric wards, geriatric outpatient clinics and primary care) and one social setting (nursing homes). Exclusion criteria include Mini-mental State Examination < 20 points, and a Barthel index < 90 points, except in nursing home residents (< 40 points). The participants will be recruited in Spain, Italy, France, United Kingdom and Poland. The total sample size will be of 1.940 subjects, 97 subjects in each clinical setting by center. A personal interview with each participant will take place to register data on comorbidity (Charlson Index), functional (SPPB, Barthel and Lawton indexes), cognitive (MMSE) and frailty status (Fried Phenotype, Frailty Trait Scale - short version, SHARE-FI, 35-Items Rockwood Frailty Index, Clinical Frailty Scale, FRAIL scale and Gérontopôle Frailty Screening Tool) in the baseline visit, month 12 and month 18 visit of follow up. At 6 month a phone call will be made to assess whether there have been falls and to check the vital status.

Discussion: Currently, the usefulness of certain assessment tools in social and clinical settings have not been properly assessed, including their ability to predict the individual risk for different adverse outcomes, which is the main interest in daily practice. The FRAILTOOLS project concentrates on providing screening and diagnostic tools for frailty in those settings where its prevalence is the highest and where efforts in prevention could make a significant change in the trend towards disability.

Trial Registration: Comprehensive validation of frailty assessment tools in older adults in different clinical and social settings (FRAILTOOLS), NCT02637518 (date of registration: 12/18/2015).