Rehse Hanna, Hasemann Lena, Ludwig Kristina, Elkenkamp Svenja, Kampmann Johanna, Nebling Thomas, Thiem Ulrich, Greiner Wolfgang
School of Public Health, AG 5-Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Nordrhein-Westfalen, Germany
School of Public Health, AG 5-Department of Health Economics and Health Care Management, Bielefeld University, Bielefeld, Nordrhein-Westfalen, Germany.
BMJ Open. 2025 Apr 29;15(4):e092893. doi: 10.1136/bmjopen-2024-092893.
Falls can lead to serious health-related consequences in the older population. If an emergency occurs within the home environment of an older person living alone, the initiation of emergency care can be delayed, leading to even worse outcomes for this population. Smart home emergency call systems (HECSs) can detect falls and automatically trigger an emergency alarm, potentially reducing time to emergency care and improving outcomes. The INES (Intelligentes NotfallErkennungsSystem-smart emergency detection system) study is a prospective randomised controlled trial conducted in three German federal states that aims to investigate the effectiveness and cost-effectiveness of a smart HECS.
Following a telephone interview, individuals aged 70 years or older, living alone, at risk of falling and willing to participate are included in the study. Participants are assigned to one of two groups depending on their previous use of a HECS. Based on the sample size calculation, the study aims to recruit n=498 participants already using a standard HECS (group A) and n=1378 participants who have not used a HECS before (group B). Within both groups, participants are randomised into the intervention arm (IA) and control arm (CA). The IA receives a smart HECS during the 21-month follow-up period. In addition to a standard HECS with a base station and a wearable radio transmitter, the smart HECS includes sensors that can detect falls and automatically trigger an alarm. The primary outcome assessed will be the days spent in the hospital after an emergency admission. Secondary outcomes include the utilisation of healthcare services and their total costs, progression of care dependency, fear of falling (Falls Efficacy Scale-International), health-related quality of life (EQ-5D-5L) and well-being (ICEpop CAPability measure for Older people).
The design and conceptualisation of the INES study were approved by the ethics committee of the Hamburg Medical Association on 26 June 2023 (2023-101032-BO-ff). Results of the INES study will be published in peer-reviewed articles.
Deutsches Register Klinischer Studien, German Clinical Trials Register DRKS00031408. Registered on 28 June 2023.
跌倒会给老年人群带来严重的健康相关后果。如果独居老年人的家庭环境中发生紧急情况，紧急护理的启动可能会延迟，从而给该人群带来更糟糕的后果。智能家居紧急呼叫系统（HECS）可以检测到跌倒并自动触发紧急警报，有可能减少紧急护理的时间并改善结果。INES（智能紧急检测系统）研究是一项在德国三个联邦州进行的前瞻性随机对照试验，旨在调查智能HECS的有效性和成本效益。
在电话访谈后，年龄在70岁及以上、独居、有跌倒风险且愿意参与的个体被纳入研究。根据参与者之前是否使用过HECS，将他们分配到两个组之一。根据样本量计算，该研究旨在招募n = 498名已经在使用标准HECS的参与者（A组）和n = 1378名之前未使用过HECS的参与者（B组）。在两组中，参与者被随机分为干预组（IA）和对照组（CA）。IA在21个月的随访期内接受智能HECS。除了带有基站和可穿戴无线电发射器的标准HECS外，智能HECS还包括能够检测跌倒并自动触发警报的传感器。评估的主要结果将是紧急入院后在医院的天数。次要结果包括医疗服务的使用情况及其总成本、护理依赖程度的进展、跌倒恐惧（国际跌倒效能量表）、健康相关生活质量（EQ - 5D - 5L）和幸福感（老年人ICEpop能力测量）。
INES研究的设计和概念化于2023年6月26日获得汉堡医学协会伦理委员会的批准（2023 - 101032 - BO - ff）。INES研究的结果将发表在同行评审的文章中。
德国临床试验注册中心，德国临床试验注册DRKS00031408。于2023年6月28日注册。
