REMAP-WEST-FLARE - FLAg for Review Efficacy Investigation
- Conditions
- COPD
- Interventions
- Device: Senti Wear device system with Senti-AI subsystem
- Registration Number
- NCT05745155
- Lead Sponsor
- Senti Tech Ltd
- Brief Summary
The goal of this clinical investigation is to explore the efficacy and economics of a novel medical device system which, through the remote monitoring and evaluation of acoustic pathophysiological parameters in long-term respiratory conditions, flags patients who are beginning to deteriorate for clinical review, in order to reduce time-to-intervention in respiratory disease flareups.
The main question it aims to answer are:
Would the use of the Senti-AI and Senti-Wear Device System reduce time-to-intervention in respiratory disease flareups?
Participants will wear the Senti-Wear device up to twice per day as tolerated for 12 weeks. The Senti-AI subsystem will generate FLAREs (flags for review) and these will retrospectively be compared to the standard of care to evaluate whether acting on the FLARES would have reduced time-to-intervention.
- Detailed Description
This clinical investigation seeks to establish whether or not the Senti-Wear device system with the Senti-AI subsystem is effective for autonomously monitoring people with long-term respiratory illness with COPD. The aim of this autonomous monitoring is to generate flags for review (FLARES) if the system detects a worsening (deterioration) in lung sounds which might indicate a worsening respiratory illness.
If effective, this device system will enable people with long-term respiratory illnesses to receive earlier intervention in disease flare-ups, ensuring these patients are on the right medication at the right time, avoiding hospital admissions, and staying well at home.
200 patients with COPD will be recruited. The design of this study is comparative. All 200 participants will undertake patient-sought care as usual, where patients seek medical aid once starting to feel more unwell. Over a six-month period, we will collect data on what care is sought and when this changes treatment. Participants will also use the Senti-Wear device to capture their breath and heart sounds twice a day over this six-month period. Participants, clinicians, and the research team will be blinded to the device output FLARES until the end of the data collection period.
At the end of the data collection period, we will compare this with Senti-AI FLARES, to determine whether acting on FLARES would have led to early intervention in disease flareups.
The study activities will take place in the participants' own homes. The study will recruit around Manchester and Liverpool, UK. The study is being funded by Senti-Tech limited, the manufacturer of the Senti-Wear with Senti-AI device system.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Diagnosis of COPD (on GP record is acceptable) and at least one COPD exacerbation requiring steroid prescription in the last three years
- Participants with significant cognitive impairment or limiting physical disabilities - to the extent that they are not able to manage their own Activities of Daily Living; except where sufficient family or care support is available to manage the device functions (in which case, the device may be used with caution).
- Participants with existing pressure sores across the thorax and/or torso.
- Participants under the age of 18.
- Participants with a height outside the range (150-189cm)
- Participants with a waist circumference outside the range (62-169cm)
- Participants with a known sensitivity or allergy to any of the components of the device.
- Participants unable to give their consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Senti-Wear with Senti-AI Senti Wear device system with Senti-AI subsystem Participants will wear the Senti-Wear smart garment up to twice per day (as tolerated) and complete a study journal detailing issues with the device and changes to their respiratory illness.
- Primary Outcome Measures
Name Time Method AUC at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment 12 weeks Area under the Receiver Operator Characteristic curve (AUC) for FLAREs at 24 hours, 48 hours, 72 hours, 5 days, and 10 days prior to a definitive change in treatment being initiated (such as antibiotics/steroids prescription). This outcome measure is clinically meaningful as this metric quantifies the performance of the system for reducing time-to-intervention in respiratory disease flareups by specific time intervals. Earlier intervention in respiratory disease flareups, in turn, will improve outcomes, reduce hospitalisations, and improve quality of life.
- Secondary Outcome Measures
Name Time Method FLAREs False Positive Rate 12 weeks False Positives (Proportion of FLARES where there was no change in care in the following three weeks under the standard of care). As if the false positive rate is too high, then this will increase burden on services through unnecessary clinical reviews.
Total sum length of stay of any hospital admissions 12 weeks Total sum length of stay of any hospital admissions
Number of GP visits 12 weeks Number of GP visits
Usability 12 weeks Technical and usability device-related issues - qualitative thematic reporting of issues reported by users related to operating the device. As this will drive improvements in future generations of the device.
ADEs 12 weeks Adverse device events. As this will quantify the risks associated with use of the device.
Average time difference between FLAREs and change in treatment 12 weeks Average time difference between true-positive FLARE to change in treatment. Change in treatment is defined as antibiotic/steroid/nebuliser acute prescription or change in respiratory preventative medication.
Device utilisation 12 weeks Cumulative time device was worn and recorded data over. This will provide an idea of device usability, uptake, and churn.
Number of specialist respiratory appointments 12 weeks Number of specialist respiratory appointments
Respiratory Symptomology 12 weeks Correlation between FLARES and change in symptomatology. As this will provide supportive evidence of the algorithm's efficacy.
Number of A&E attendances 12 weeks Number of A\&E attendances
Number of hospital admissions 12 weeks Number of hospital admissions
Trial Locations
- Locations (1)
Senti Tech
🇬🇧Liverpool, Merseyside, United Kingdom