Advanced Practice Nurses for Fall Incidence prevenTion in robust very old adults: protocol for the APN-FIT hybrid randomized controlled trial

Background Falls in older adults represent a major cause of disability and a pivotal indicator of the transition from robustness to frailty. Despite their proven effectiveness, the implementation of large-scale prevention programs has proved challenging, requiring the mobilization of extensive skills and human resources. In France, the role of Advanced Practice Nurses (APN) is becoming increasingly prominent, given their multimodal approach and nursing expertise, along with their clinical expertise. Methods This study is a hybrid, type 1, multicenter, randomized, open-label, superiority trial conducted in seven medical centers in the Pays de la Loire region in France. The primary objective is to assess the effect of a 12-month personalized multimodal follow-up by APNs on the incidence of falls in non-frail patients (Clinical Frailty Scale ≤ 3) aged over 80. Furthermore, a mixed ancillary study focusing on the intervention implementation will be conducted, and a cost-utility analysis will be performed. All 386 participants will be enrolled by APNs during an initial comprehensive geriatric assessment (CGA) and will be eligible to participate in a tailored home-based physical activity program. The intervention group will be followed by the APN 1, 3, 6, 9 and 12 months after inclusion. Primary and secondary outcomes, including those relating to intrinsic capacity domains, will be assessed in all participants during a second CGA at M12. Discussion In addition to a reduction in the incidence of falls, we expect that APNs will reduce the number of patients progressing to pre-frailty, frailty and impaired mobility. This study stands out for its hybrid design and the comprehensiveness of the geriatric assessment for assessing outcomes. The inclusion of 386 participants may be challenging and the retrospective collection of data on falls may be subject to memory biases. However, the results are likely to improve knowledge of the effect of APN follow-up in older adults and to optimize the implementation of APN-driven fall prevention programs in real-life situations. Trial registration This study has been registered on clinicaltrials.gov, NCT06617806, registration date 2024-09-26.