Frailty and Falls Implantable System for Prediction and Prevention Investigational Study - FFallS Predictor
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the number of falls associated with early changes in physiological parameters as recorded by the investigational Reveal LINQ™ Falls Prediction System.
研究概览
简要总结
The Falls Predictor Clinical Investigation is a research study that aims to investigate the value of an update (Falls Prediction RAMware) to an implantable cardiac monitoring device (The Reveal LINQ™) in predicting unexplained falls. The Reveal LINQ™ is an implantable cardiac monitoring system manufactured by Medtronic that has the ability to monitor heart rate, rhythm and activity and is preprogrammed to detect abnormalities. An R&D team at Medtronic has been collaborating with the study PI Prof Rose Anne Kenny on this project they are responsible for developing a software update for the Reveal LINQ™ that would enable the device to collect additional sensor data such as accelerometer (step count) and Posture change. The additional investigational fields along with the standard cardiac fields that are monitored may be useful in predicting or identifying physiological changes before a fall. The study will involve up to 30 patients, recruited and consented from recurrent non-accidental fallers referred to the Falls and Syncope Unit at St James's Hospital, Dublin.
详细描述
Falls are an evolving frailty state and are the most common reason for older adults to attend the Emergency Room (ER) and for admission to long term institutional care. The Irish Longitudinal Study on Ageing (TILDA) has shown that almost 40% of older adults reported at least one fall during a four year period and almost 50% had 'fear of falling', an independent risk factor for falls and loss of independence. New mechanisms for monitoring early risk factors for falls will advance prevention and management of these conditions, improving healthcare and supporting independent living.
Implantable devices are a new addition to the sensor market, and as yet have limited capabilities.
This study is focused on 'unexplained' or 'non accidental' falls- that is falls which are not clearly due to a slip or a trip. Previous research shows that a high number of these may be due to changes in heart rate and irregular heartbeats (heart rhythm). There may also be other changes associated with non accidental falls, such as activity levels i.e. how active you are in the time before a fall.
Patients under the care of FASU undergo a full clinical assessment, where the medical team aim to identify and treat factors which might contribute to falls. They often manage such falls by implanting a monitoring device which will measure heart rate and rhythm. The Reveal LINQ™ device from Medtronic™, is the implantable monitoring device which is used in FASU. There is scope to further develop implantable devices such as the Reveal LINQ™ to monitor additional physiological parameters, which may help identify fall risk factors. Medtronic in collaboration with the PI Prof Kenny have developed a RAMware update for the Reveal LINQ™ which will enable the collection of additional sensor information. The Falls Prediction RAMware is programmed externally to the Reveal LINQ™, there are no changes to the physical properties of the device.
Study Aim:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to St James's due to a non-accidental fall (not a slip or trip), with a history of another non-accidental fall or syncope within the previous 3 years.
- •Age ≥ 50 Years
- •Participant is willing and has capacity to provide informed consent to the study
排除标准
- •Inability or unwilling to follow or perform the study protocol requirements
- •Cognitive impairment (MMSE </= 20)
- •Current Pacemaker or other implanted therapy devices.
- •Known intolerance to subcutaneous implantable devices or any of the Reveal LINQ™ materials.
- •Life expectancy < 12 months
研究组 & 干预措施
Reveal LINQ
The Reveal LINQ™, which is a small implantable loop recorder that is used to monitor cardiac parameters at present is implanted to the participants who are have experienced non accidental falls. The Investigational Falls Prediction RAMware is software that will be downloaded on to the Reveal LINQ™ that will enable it to collect additional sensor information including accelerometer and posture count data.
干预措施: Reveal LINQ™ (Device)
结局指标
主要结局
the number of falls associated with early changes in physiological parameters as recorded by the investigational Reveal LINQ™ Falls Prediction System.
时间窗: 16 months
Uses the Reveal LINQ™ Falls Prediction Research System to identify early changes in physiological parameters which helps to create a profile on which to predict falls, with the potential to implement a score for the risk of falling based on monitoring of frailty parameters in the elderly measured with the implantable device.
次要结局
- Established research of cardiac parameters of Reveal LINQ(16 months)
- Development of Clinical risk stratification algorithm(16 months)
研究者
Prof. Rose Anne Kenny
Professor
University of Dublin, Trinity College