Frailty and Falls Implantable System for Prediction and Prevention Investigational Study - FFallS Predictor
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- the number of falls associated with early changes in physiological parameters as recorded by the investigational Reveal LINQ™ Falls Prediction System.
Study Overview
Brief Summary
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.
Detailed Description
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
the number of falls associated with early changes in physiological parameters as recorded by the investigational Reveal LINQ™ Falls Prediction System.
Time Frame: 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.
Secondary Outcomes
- Established research of cardiac parameters of Reveal LINQ(16 months)
- Development of Clinical risk stratification algorithm(16 months)
Investigators
Prof. Rose Anne Kenny
Professor
University of Dublin, Trinity College