Morais Daiene, Gramani-Say Karina, Melo Mariana Luiz de, Dias Ana Laura Oliveira, Vassimon-Barroso Verena, Ponciano Jean Roberto, Godoi-Jacomassi Daniela, Ansai Juliana Hotta
Department of Gerontology, Federal University of São Carlos, São Carlos 13565-905, Brazil.
Graduate Program of Gerontology, Department of Gerontology, Federal University of São Carlos, São Carlos 13565-905, Brazil.
Healthcare (Basel). 2025 Jul 25;13(15):1814. doi: 10.3390/healthcare13151814.
: There is a need for randomized clinical trials with higher quality, especially for older people at high risk of falls, with interventions that consider individual needs, comprehensiveness of care, and connection with primary health care. We designed a randomized controlled trial to examine the effects of a case management intervention combined with a physical exercise protocol on risk factors for falls, falls data, adherence, satisfaction, costs, and implementation in community-dwelling older adults with high risk of falls. : A minimum of 60 community-dwelling older people with high falls risk will participate in the randomized controlled assessor-blinded trial (MAGIC-v. 2). The trial will be conducted in a regional health department of São Paulo state (Brazil), which includes 6 cities. Participants will be randomized to the Intervention Group (case management intervention based on all individual risk factors for falls identified by a multidimensional assessment, over 16 weeks, once a week, by telephone calls). Both groups will perform a physical exercise protocol based on falls prevention for 16 weeks (twice a week) in Health Units. The assessment will be performed at baseline, after 16 weeks of intervention, after 6-month follow-up, and after 12-month follow-up. Primary outcome measures include falls data and potentially modifiable risk factors for falls. : This study has the potential to facilitate the future implementation of the intervention based on case management with a focus on fall prevention in the health sectors. : Brazilian Registry of Clinical Trials (ReBEC).
需要开展更高质量的随机临床试验,特别是针对跌倒风险高的老年人,采用考虑个体需求、护理全面性以及与初级卫生保健相联系的干预措施。我们设计了一项随机对照试验,以研究病例管理干预与体育锻炼方案相结合对社区居住的跌倒高风险老年人的跌倒风险因素、跌倒数据、依从性、满意度、成本及实施情况的影响。
至少60名社区居住的跌倒高风险老年人将参与随机对照评估者盲法试验(MAGIC-v. 2)。该试验将在巴西圣保罗州的一个地区卫生部门进行,该部门包括6个城市。参与者将被随机分配到干预组(基于多维评估确定的所有个体跌倒风险因素进行病例管理干预,为期16周,每周一次,通过电话进行)。两组都将在卫生单位进行为期16周(每周两次)的基于预防跌倒的体育锻炼方案。评估将在基线、干预16周后、6个月随访后和12个月随访后进行。主要结局指标包括跌倒数据和潜在可改变的跌倒风险因素。
本研究有可能促进未来在卫生部门实施以病例管理为基础、侧重于预防跌倒的干预措施。
巴西临床试验注册中心(ReBEC)。