Alcolea-Ruiz Nuria, López-López Candelas, Pérez-Pérez Teresa, Alcolea Sonia, Pérez-Rivas Francisco Javier
Sector III Healthcare Centre, South Assistance Directorate, Primary Care Assistance Management, Madrid Health Service, 28905 Madrid, Spain.
Faculty of Nursing, Physiotherapy, and Podiatry, Complutense University of Madrid, 28040 Madrid, Spain.
Healthcare (Basel). 2024 Dec 11;12(24):2510. doi: 10.3390/healthcare12242510.
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. 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. 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.
害怕跌倒（FOF）和跌倒在老年人中是普遍存在的问题，会导致活动受限、生活质量下降和依赖性增加。本研究旨在评估由护士主导的健康教育干预措施在初级保健环境中减少老年人FOF和跌倒发生率的有效性。这项双臂、多中心、平行、整群随机临床试验包括西班牙的10个初级保健中心，将招募150名65岁以上有FOF、轻度或无功能依赖且能够独立行走的成年人。参与者将被随机分为干预组和对照组，干预组将接受由社区护士主持的5次初始小组教育课程，并在6个月时接受一次强化课程，对照组将接受常规护理。主要结局包括使用国际跌倒效能简表（FES-I）评估的FOF和跌倒发生率。数据收集将在干预后的基线、1个月、6个月和12个月进行。本研究已获得格雷戈里奥·马拉尼翁大学医院药品研究伦理委员会根据《赫尔辛基宣言》的批准。预计健康教育干预将显著降低FOF和跌倒发生率，支持将FOF管理纳入老年人常规初级保健中，对安全性和生活质量可能有益。试验注册：ClinicalTrials.gov：NCT05889910。研究方案遵循CONSORT和SPIRIT指南。
