Advanced practice nurses for fall incidence prevention in robust very old adults: protocol for the APN-FIT hybrid...

Falls in older adults represent a major cause of disability and a pivotal indicator of the transition from robustness to frailty. Implementing large-scale prevention programs remains challenging because it requires the mobilization of extensive skills and human resources. In France, Advanced Practice Nurses (APN) are emerging as key actors in primary care, with the potential to provide multimodal, preventive, and patient-centered follow-up for older adults.

The APN-FIT trial (Advanced Practice Nurses for Fall Incidence prevenTion in robust very old adults) is a hybrid type 1, multicenter, randomized, open-label, superiority trial conducted in seven medical centers in the Pays de la Loire region, France. The study will assess whether a 12-month, personalized, multimodal follow-up by APN reduces fall incidence among robust participants aged ≥ 80 years (Clinical Frailty Scale ≤ 3). A mixed-methods implementation study and a cost-utility analysis will be performed. A total of 386 participants will be randomized 1:1 after an initial comprehensive geriatric assessment (CGA). The intervention group will be followed by APN at 1, 3, 6, 9, and 12 months. Primary and secondary outcomes, including intrinsic capacity domains, will be reassessed at 12 months.

We expect that APN follow-up will reduce fall incidence and delay transitions to pre-frailty or impaired mobility. This pragmatic hybrid trial will provide evidence on the clinical, economic, and implementation impact of APN-led fall prevention in community-dwelling very old adults.

This study has been registered on clinicaltrials.gov, NCT06617806, registration date 2024-09-26.