Effect of a Health Education Intervention to Reduce Fear of Falling and Falls in Older People: A Cluster Randomized Clinical Trial Protocol

Abstract

Background/Objectives: Fear of falling (FOF) and falls are prevalent issues among older adults, leading to activity restriction, decreased quality of life, and increased dependency. This study aims to assess the effectiveness of a nurse-led health education intervention to reduce FOF and fall incidence in older adults within primary care settings. Methods: This two-arm, multicenter, parallel, cluster-randomized clinical trial includes ten primary care centers in Spain and will enroll 150 adults over 65 years with FOF, mild or no functional dependence, and independent ambulation. Participants will be randomized to either the intervention group, which will receive five initial group education sessions led by community nurses and a booster session at six months, or the control group, which will receive usual care. Primary outcomes include FOF, assessed using the Short Falls Efficacy Scale-International (FES-I), and fall incidence. Data collection will occur at baseline, one month, six months, and twelve months post intervention. This study has been approved by the Ethics Committee for Research with Medicinal Products at Gregorio Marañón University Hospital in accordance with the Declaration of Helsinki. Expected Outcomes: The health education intervention is expected to significantly reduce both FOF and fall incidence, supporting the integration of FOF management in routine primary care for older adults, with potential benefits for safety and quality of life. Trial Registration: ClinicalTrials.gov: NCT05889910. The study protocol follows CONSORT and SPIRIT guidelines.