Efficacy of a multiple-component and multifactorial personalized fall prevention program in community-dwelling older adults at moderate-to-high fall risk: The PRE.C.I.S.A. Randomized Controlled Trial

Background: The fall risk in the elderly is a major public health issue due to the immediate injury-related consequences and the risk of associated long-term disability. However, the delivery of effective interventions for fall prevention in usual clinical practice still represents a challenge. Aim: To evaluate the efficacy of a multiple-component intervention combined with a multifactorial personalized intervention in reducing fall rates in community-dwelling older adults at moderate-to-high fall risk compared to usual care. Design: Randomized Controlled Trial (unique identifier NCT03592420, clinicaltrials.gov). Setting: Outpatients in two Italian centers. Population: 403 community-dwelling older adults at moderate-to-high fall risk, including subjects with Parkinson Disease and stroke. Methods: Subjects were randomized to the intervention (n=203) or the control group (n=200). A multiple-component and multifactorial personalized interventions were administered to the experimental intervention group. Participants allocated to the control group received usual care and recommendations to minimize the fall risk factors. In addition, each participant was given a diary to record falls and was followed for 12 months with monthly telephone contacts. The primary endpoint was represented by the total number of falls in each group over 12 months. The secondary endpoints were other fall-related indicators (fall rate of subjects with one or more falls, fall rate associated with hospitalization, fall severity, fall probability, and time to the first fall) recorded at the 12-month follow-up. Besides, several clinical scales were used to assess baseline (T1) and 3-month follow-up (T3) functioning. Results: A total of 690 falls were reported at 12-month follow-up, 337 (48.8%) in the intervention group and 353 (51.2%) in the control group with 1.66 ({+/-} 3.5) and 1.77 ({+/-} 3.2) mean falls per subject, respectively. The number of subjects with at least one fall was 236 (58.6%), with 119 (58.6%) and 117 falls (58.5%) in the intervention and control groups, respectively. No statistically significant differences were observed between groups regarding the number of falls, the fall probability, and the time to the first fall at 12-month follow-up. Furthermore, according to the subgroup analysis, no significant differences were reported between subgroups (i.e., the four etiological class categories of interest for the study). Finally, considering the two groups at pre-test (T1) and post-test (T3) evaluations, a statistically significant difference was found only for the Fullerton Advanced Balance Scale (p=0.006) and the Mini-BESTest (p=0.004) in favor of the intervention group. Conclusions: The proposed intervention was ineffective in reducing the number of falls, the fall probability, and the time to the first fall at 12-month follow-up in community-dwelling older adults at moderate-to-high fall risk. However, a lower number of falls, lower fall rates in multiple fallers, a lower mean number of falls per participant, and a lower rate of fall-related severe injuries were recorded for the intervention group, although not significant. Finally, a significant improvement for two balance-related indicators was recorded in the intervention group between pre and post-test evaluations. Future studies are needed to explore different effects of combined multiple-component and personalized multifactorial interventions to reduce falls and subsequent consequences. Future studies should also be planned with the clear aim of overcoming the limitations highlighted in the PRE.C.I.S.A. study.