A Real-world Wearables Study in Fabry Disease.
NCT Number: NCT06484478
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fabry Disease
Interventions: OTHER: Wearable technology monitoring
Sponsor: Royal Free Hospital NHS Foundation Trust
Collaborators: Brunel University|Sanius Health
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2025-12-31
Locations: Royal Free London NHS Foundation Trust, London, United Kingdom

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 individual'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 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.

Primary Outcome Measures: Quality of life - via EuroQol five-dimension questionnaire (EQ-5D-5L)., Quality of life measured using the self-report EuroQol five-dimension questionnaire (EQ-5D-5L). The questionnaire is comprised of five dimensions which are each divided into five levels of severity i.e. 1 = no problem, 2 = slight problems, 3 = moderate problems, 4 = severe problems, and 5 = unable to/extreme problems. A five-digit health state score is then found by combining the levels of severity for each dimension i.e. 11111 is the best health state and 55555 is the worst health state., 12 months
Secondary Outcome Measures: Anxiety, Anxiety measured using the self-report Hospital Anxiety and Depression Scale (HADS) questionnaire. HADS has 14 questions which measure anxiety (7 questions) and depression (7 questions). Each question is scored from 0 to 3 and total scores for anxiety (out of 21) and depression (out of 21) are calculated. Scoring is as follows: 0 - 7 = normal, 8 - 10 = borderline abnormal and 11 - 21 = abnormal., 12 months|Depression, Depression measured using the self-report Hospital Anxiety and Depression Scale (HADS) questionnaire. HADS has 14 questions which measure anxiety (7 questions) and depression (7 questions). Each question is scored from 0 to 3 and total scores for anxiety (out of 21) and depression (out of 21) are calculated. Scoring is as follows: 0 - 7 = normal, 8 - 10 = borderline abnormal and 11 - 21 = abnormal., 12 months|Mood, Mood measured using a basic 0 - 10 scale i.e. 0 = poor mood, 10 = the best mood., 12 months|Pain - Pain measured using a basic 0 - 10 scale i.e. 0 = no pain, 10 = the worst pain, Pain measured using a basic 0 - 10 scale i.e. 0 = no pain, 10 = the worst pain., 12 months