Monitoring physical activity and mental health in Fabry disease patients using wearables.
A Real-world Monitoring Project Exploring Day-to-day Physical Activity, Sleep, and Quality of Life in Individuals with Fabry Disease.
This study is trying to see how physical activity affects mental health in adults with Fabry disease by using wearable devices to track their movement and mood.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Free Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06484478 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on patients with Fabry disease by utilizing clinical-grade wearable devices to monitor physical activity levels and sedentary behavior. Participants will complete baseline questionnaires assessing anxiety, depression, and quality of life, while also providing clinical data from their medical records. The study will focus on individuals aged 18 and older who have a confirmed diagnosis of Fabry disease and are capable of independent mobility. The data collected will help understand the relationship between physical activity and mental health outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with a confirmed diagnosis of Fabry disease who can provide informed consent and are physically able to stand and ambulate independently.
Not a fit: Patients who are unable to use wearable devices or communicate effectively in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved management strategies for mental health and physical activity in patients with Fabry disease.
How similar studies have performed: While studies on wearable technology in other conditions have shown promise, this specific approach in Fabry disease is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Fabry disease documented by genotyping and/or enzymatic analysis. * Resident in the UK. * Aged 18 years and over. * Capable of providing informed consent. * Physically able to stand and ambulate independently. Exclusion Criteria: * A known allergy to any materials in the wearable device. * Not able to have or use a wearable. * Taking part in an interventional study which would preclude real-world data collection. * Unable to communicate in English to a sufficient level to permit engagement in the study.
Where this trial is running
London
- Royal Free London NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Derralynn Hughes, Professor
- Email: derralynnhughes@nhs.net
- Phone: 020 7794 0500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.