Background <p>Fear of falling (FOF) and falls are prevalent and interconnected. Studies suggest that intervention programs can reduce FOF and prevent falls. The primary objective was to assess the effectiveness of this nurse-led intervention in reducing FOF.</p> Methods <p>This two-arm, parallel, multicenter, cluster-randomized clinical trial was conducted in ten primary care facilities in Madrid, Spain. Participants were ≥ 65 years old with FOF, independent or mildly dependent, ambulatory, and cognitively intact. Recruitment began on February 13, 2023, and the final follow-up was completed on May 30, 2024. Randomization assigned five facilities per group (1:1). The intervention was a nurse-led multicomponent group programme combining exercise, fall-prevention education, and cognitive-behavioral techniques (five weekly sessions plus a two-hour booster at six months), compared to usual care. The primary outcome was the Short Falls Efficacy Scale-International (FES-I) score, collected at baseline and at months one, six, and 12. Additional variables included sociodemographic, functional, clinical, and usual footwear data. Blinding was limited to recruitment; professionals were unaware of assignments, data were coded and analyzed by an independent third party, and the principal investigator, involved in fieldwork, was not blinded. Intervention effects were evaluated in intention-to-treat and per-protocol populations using fixed-effects ANOVA or logistic regression models as appropriate, with facility nested within group. Mixed-effects and cluster-level analyses were conducted as sensitivity analyses.</p> Results <p>A total of 163 randomized participants from 10 primary care facilities were analyzed (mean age: 77.8 SD = 6.1 years; 127 [78%] women). In the intention-to-treat analysis, mean Short FES-I score was significantly lower in the intervention group compared to the control group at one month (2.599 points, 95% CI: 0.942, 4.256, <i>p</i> &lt; 0.001), although differences at six and twelve months were not statistically significant. In the dichotomous analysis, the proportion of participants without FOF was consistently higher in the intervention group at 12 months (42.6% vs. 16.2%, OR = 0.23, 95% CI: 0.066–0.758, <i>p</i> = 0.013), corresponding to a 77% reduction. No major adverse events or side effects were reported.</p> Conclusions and implications <p>This nurse-led intervention was effective in reducing FOF in the short term, and although benefits were observed at long-term follow-up, these did not reach statistical significance, and the magnitude of the observed effect was lower than initially anticipated. No significant reduction in fall incidence was observed, the program proved feasible and well-tolerated. Integrating fear of falling assessment and targeted interventions into routine primary care could enhance older adults’ functional independence.</p> Trial registration <p>Registered at ClinicalTrials.gov NCT05889910. Record Verification on May 8, 2023. Funded by the Official College of Nursing of Madrid (Grant AYD263_2022).</p>