- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04881136
Frailty and Falls Implantable System for Prediction and Prevention (FFallS)
Frailty and Falls Implantable System for Prediction and Prevention Investigational Study - FFallS Predictor
Study Overview
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:
The aim of this project is to use the investigational build on previous work and use an implantable device (Reveal LINQ™) to monitor cardiac parameters, such as heart rate, rhythm and variability and to enhance the monitoring capabilities of the device with additional investigational software (Falls Predictor RAMware), creating the Reveal LINQ ™ Falls Prediction System (LINQ FP). The RAMware update will enable the Reveal LINQ™ device to collect additional sensor information including temperature, posture, accelerometer (step measure) and impedance measure (information on activity and fluid status), to identify early changes in these measures that may indicate increased risk of a fall.
Study Design:
This is a prospective, single centre, pilot feasibility study, which aims to investigate the value the Reveal LINQ ™ Falls Prediction System (LINQ FP) in predicting falls or identifying fall risk. Participants will be recruited from recurrent fallers referred to FASU for assessment. A full set of baseline assessments will be performed as necessary. Participants will have a Reveal LINQ™ Device Implanted that will be updated with the Falls Prediction RAMware. The Falls Prediction RAMware is programmed externally to the Reveal LINQ™, there are no changes to the physical properties of the device.
Participants will be followed in the study for 12 months, with in clinic follow up assessments at 3, 6, 9 and 12 months
Recurrent non-accidental fallers (n=30) over the age of 50 will be invited to participate in the investigation, provided both inclusion and exclusion criteria are met. The study will take place at St James's Hospital, in the Falls and Syncope Unit at MISA.
Clinical data collection, processing, and data analysis will be conducted on-site by the study nurse and doctor and the on-site data manager recruited to the study team. The data collected by the investigational Falls Predictor software will be transmitted via CareLink™ and will be processed and analysed by Medtronic.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sergio R Perez, M Sc
- Phone Number: 014284182
- Email: PEREZSR@tcd.ie
Study Locations
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Leinster
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Dublin, Leinster, Ireland, 8
- Recruiting
- Falls and Syncope Unit (FASU), Mercer's Institute for Successful Aging (MISA), St James's Hospital, Dublin 8
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Contact:
- Sergio Perez, M Sc
- Phone Number: 014284182
- Email: PEREZSR@tcd.ie
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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. 5. Life expectancy < 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
The physical device is the Reveal LINQ™, which is a small implantable loop recorder that is used to monitor cardiac parameters at present.
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 that will be used for gait analysis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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16 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Established research of cardiac parameters of Reveal LINQ
Time Frame: 16 months
|
building on established research of the cardiac parameters of the Reveal LINQ ™ to identify heart rate and rhythm disturbances in fallers and to evaluate their role in predicting a fall.
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16 months
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Development of Clinical risk stratification algorithm
Time Frame: 16 months
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Developing a clinical risk stratification algorithm for management, treatment and prevention of frailty and Falls.
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16 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rose Anne Kenny, MD FRCP, University of Dublin, Trinity College
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRI CRF 20-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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