Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484478
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-12
Brief Title:
A Real-world Wearables Study in Fabry Disease
Sponsor:
Royal Free Hospital NHS Foundation Trust
Organization:
Royal Free Hospital NHS Foundation Trust
Study Overview
Official Title:
A Real-world Monitoring Project Exploring Day-to-day Physical Activity Sleep and Quality of Life in Individuals With Fabry Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the care pathway for Fabry disease patients are typically seen in person every 12 months This creates long intervals between assessments which themselves present very artificial snapshots of an individuals exercise capacity in their day-to-day life This misses what is actually going on in terms of patient sleep or activity As such the creation of an evidence base of patient data will be important in understanding behaviours related to physical activity that are associated with pain mood quality of life and disease phenotypes in individuals with Fabry disease
These will be tracked through a combination of hospital medical records a thigh-worn physical activity device worn over a period of seven days real-time data collected from a wrist-worn device and patient-reported outcomes By combining a patients data into a digital patient profile the aim is to provide patients and clinicians with better insight into physical activity behaviours that may be considered targets for interventions for improved care and quality of life
Individuals with Fabry disease aged 18 years or above will be considered for eligibility screening The study will be conducted remotely with participants using the digital data platform and wearable devices in their day-to-day lives over a period of approximately 12 months
These will be tracked through a combination of hospital medical records a thigh-worn physical activity device worn over a period of seven days real-time data collected from a wrist-worn device and patient-reported outcomes By combining a patients data into a digital patient profile the aim is to provide patients and clinicians with better insight into physical activity behaviours that may be considered targets for interventions for improved care and quality of life
Individuals with Fabry disease aged 18 years or above will be considered for eligibility screening The study will be conducted remotely with participants using the digital data platform and wearable devices in their day-to-day lives over a period of approximately 12 months
Detailed Description:
Trial assessments
Baseline questionnaires
Baseline questionnaires will include the Hospital Anxiety and Depression Scale HADS and the EuroQol 5-dimension questionnaire EQ-5D-5L This will be administered via Jisc Online Surveys
Thigh-worn device activPAL
Participants will attach the activPAL device to their anterior thigh for 7 full days and continue their usual daily behaviour throughout the week This will measure sitting standing stepping and sleep time This device is accompanied by a hard copy daily diary where participants will be asked to input the time they wake up they get out of bed they get into bed and when they go to sleep
Smartwatch Withings ScanWatch
Participants will be asked to wear the Withings ScanWatch day and night for a duration of 12 months Physical activity sleep quality and heart rate data will be collected through this device on a continuous basis Manually recorded data on the device includes electrocardiogram ECG and blood oxygen saturation percentage SpO2 on a weekly basis
Withings ScanWatch app
This software application will be download onto participants smart devices to allow the synchronization of data between the smartwatch and the Sanius ecosystem
Sanius digital wallet app
Participants will be able to complete the following questionnaires completed daily with an option for retrospective recall of up to 1 week EQ-5D-5L HADS and patient-reported pain and mood scores simple 0 - 10 scale
Clinical data and hospital admissions
Data from medical records will include disease phenotype and clinical severity including mutation type lyso-Gb3 left ventricular mass index and diastolic dysfunction Such data will be sourced from electronic patient records Mainz Severity Score Index and its age-adjusted score will be calculated from data on electronic patient records These will be collected retrospectively from the previous 12 months upon enrolment and then prospectively over the 12-month study period Hospital admissions will be calculated from electronic patient records or hospital episode statistics
Baseline questionnaires
Baseline questionnaires will include the Hospital Anxiety and Depression Scale HADS and the EuroQol 5-dimension questionnaire EQ-5D-5L This will be administered via Jisc Online Surveys
Thigh-worn device activPAL
Participants will attach the activPAL device to their anterior thigh for 7 full days and continue their usual daily behaviour throughout the week This will measure sitting standing stepping and sleep time This device is accompanied by a hard copy daily diary where participants will be asked to input the time they wake up they get out of bed they get into bed and when they go to sleep
Smartwatch Withings ScanWatch
Participants will be asked to wear the Withings ScanWatch day and night for a duration of 12 months Physical activity sleep quality and heart rate data will be collected through this device on a continuous basis Manually recorded data on the device includes electrocardiogram ECG and blood oxygen saturation percentage SpO2 on a weekly basis
Withings ScanWatch app
This software application will be download onto participants smart devices to allow the synchronization of data between the smartwatch and the Sanius ecosystem
Sanius digital wallet app
Participants will be able to complete the following questionnaires completed daily with an option for retrospective recall of up to 1 week EQ-5D-5L HADS and patient-reported pain and mood scores simple 0 - 10 scale
Clinical data and hospital admissions
Data from medical records will include disease phenotype and clinical severity including mutation type lyso-Gb3 left ventricular mass index and diastolic dysfunction Such data will be sourced from electronic patient records Mainz Severity Score Index and its age-adjusted score will be calculated from data on electronic patient records These will be collected retrospectively from the previous 12 months upon enrolment and then prospectively over the 12-month study period Hospital admissions will be calculated from electronic patient records or hospital episode statistics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None