Trial design
cognitive impairment, fatigue, and loss of weight, Frailty, involuntary weight loss
ONCOLOGY, RECRUITMENT
FRAILCLINIC (NCT02643069) was a phase III multicentric randomized clinical trial conducted between June 2016 and March 2021. We recruited inpatients older than 75 years admitted to some of the following clinical settings: emergency room (ER), cardiology and surgery (both as an elective‐ES and urgent surgery‐US). The study was carried out in two hospitals in Spain (University Hospital of Getafe and Monte Naranco Hospital, Oviedo), two in Italy (Sacro Cuore University Hospital and San Rafael Hospital, both in Rome) and one setting in the United Kingdom (Luton & Dunstable University Hospital, that was substituted by the Aston University Hospital in the last 6 months of the trial). The settings were selected based on the availability of the centers where the study was conducted. Oncology department was also initially included, but was finally discarded in the early phases of the study due to lack of recruitment. Participants were recruited consecutively among all the patients (age > 75 years) who attended the four settings of the study. The setting of care registered in the database for every participant was the one where they were contacted for the first time by the Geriatric Team. Researchers checked every day those admissions and excluded those with data informing about exclusion criteria in the electronic clinical records. After this first selection, they met the potential participants and after obtaining their verbal acceptance to be screened, they were assessed regarding their frailty status at admission by means of two validated frailty tools: the Fried's Frailty Phenotype (FP)Very briefly, the Fried Frailty Scale assesses five domains: fatigue, involuntary weight loss, slow gait speed, low grip strength and low levels of physical activity. The FRAIL scale evaluates fatigue, resistance, ambulation, illnesses and loss of weight. Using either tool, an individual is frail if they met three or more of the five frailty criteria. Exclusion criteria were moderate to severe cognitive impairment (Mini‐Mental State Examination (MMSE)Baseline characteristics for both groups were recorded during the first 24 h after admission, including demographic and anthropometric characteristics, medical history (admission diagnosis and co‐morbidities) and medication use recorded from clinical records. Basal (1 week before admission) functional [Barthel Index (which ranges from 0 to 100, the latter the best independence score) and Lawton scale (scoring from 0 to 6, being 6 the score for an independent statusParticipants were randomized 1:1 automatically using a random number registry conducted by a blinded manager at each centre.