A real-world wearables study in Fabry disease.

  • Research type

    Research Study

  • Full title

    A real-world monitoring project exploring day-to-day physical activity, sleep, and quality of life in individuals with Fabry disease.

  • IRAS ID

    320134

  • Contact name

    Derralynn Hughes

  • Contact email

    derralynnhughes@nhs.net

  • Sponsor organisation

    Royal Free London NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 5 months, 31 days

  • Research 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 a patient’s 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 patient’s data into a complete 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.
    Fabry disease patients aged 18 years or above will be considered for eligibility screening. The study will be conducted remotely, with patients using the digital data platform and wearable devices in their day-to-day lives over a period of approximately 12 months.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    24/NW/0173

  • Date of REC Opinion

    13 Jun 2024

  • REC opinion

    Further Information Favourable Opinion