OBJECTIVE: This paper describes the protocol for a single-blind, parallel-group randomized controlled trial that aims to investigate the effectiveness and cost-effectiveness of a home-based multifactorial program targeting fall risk factors among people aged 60 years and over who have fallen at least twice in the past 12 months (the MAGIC trial).
METHODS: Older people with a history of at least 2 falls in the last year will be divided into 2 groups. The intervention group will receive case management at home for reducing the risk of falls, including a multidimensional assessment, explanation of fall risk factors, and elaboration and monitoring of an individualized intervention plan based on the identified fall risk factors, personal preferences, and available resources. The control group will be monitored once a month. Assessments (clinical data, fall risk awareness, physical and mental factors, safety at home, feet and shoes, and risk and rate of falls) will be carried out at baseline, after 16 weeks of the intervention, and at the posttrial 6-week and 1-year follow-up. After 16 weeks of the intervention, satisfaction and adherence to the intervention will also be assessed. Economic health will be evaluated for the period up to the posttrial 1-year follow-up.
RESULTS: Data collection started in April 2021, and we expected to end recruitment in December 2021. This case management program will address multifactorial assessments using validated tools and the implementation of individualized intervention plans focused on reducing fall risk factors.
CONCLUSIONS: This trial may provide reliable and valuable information about the effectiveness of case management for increasing fall risk awareness and reducing fall risk in older people.
BACKGROUND: Brazilian Clinical Trials Registry (ReBec) RBR-3t85fd; https://ensaiosclinicos.gov.br/rg/RBR-3t85fd.
UNASSIGNED: DERR1-10.2196/34796.
目的:本文描述了单盲,一项平行组随机对照试验,旨在调查一项以家庭为基础的多因素计划在过去12个月内至少两次跌倒的60岁及以上人群中的跌倒危险因素的有效性和成本效益(MAGIC试验).
方法:去年至少有2次跌倒史的老年人将分为2组。干预组将在家中接受病例管理,以降低跌倒风险,包括多维评估,跌倒危险因素的解释,并根据已识别的跌倒风险因素制定和监测个性化干预计划,个人喜好,和可用的资源。对照组将每月监测一次。评估(临床数据,跌倒风险意识,身心因素,家里的安全,脚和鞋子,风险和下降率)将在基线进行,经过16周的干预,以及在试验后6周和1年随访。经过16周的干预,还将评估对干预措施的满意度和依从性。将评估直至试验后1年随访期间的经济健康状况。
结果:数据收集于2021年4月开始,我们预计将于2021年12月结束招聘。此案例管理计划将使用经过验证的工具进行多因素评估,并实施旨在减少跌倒风险因素的个性化干预计划。
结论:该试验可能提供关于病例管理对提高老年人跌倒风险意识和降低跌倒风险的有效性的可靠和有价值的信息。
背景:巴西临床试验注册(ReBec)RBR-3t85fd;https://ensaiosclinicos.gov。br/rg/RBR-3t85fd.
■DERR1-10.2196/34796。