Actively Recruiting
Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study
Led by University College Dublin · Updated on 2026-02-10
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University College Dublin
Lead Sponsor
B
Beacon Hospital, Ireland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how wearable devices, specifically the Fitbit Charge 6, can help assess cardiovascular health and disease risk. The study focuses on people with varying degrees of atherosclerotic cardiovascular disease as well as a subgroup of healthy individuals, using the American Heart Association's Life's Essential 8 framework to measure heart health. The goal is to understand the relationship between data from wearables and traditional cardiovascular risk factors. Participants will wear the Fitbit Charge 6 continuously for six months, with their biometric data collected throughout the study. They will undergo clinical cardiovascular assessments at the start, midpoint (three months), and end of the study, during which their Life's Essential 8 score will be calculated. Alongside these assessments, participants will complete several questionnaires on physical activity, mental health, sleep quality, and other health behaviors both during visits and weekly or monthly online. During the study, participants will provide continuous wearable data and complete patient-reported outcome measures regularly online. Researchers will monitor changes in wearable biometrics and their association with cardiovascular health scores and risk factors. The study will also classify cardiovascular health tiers and track mental, behavioral, and sleep-related factors. This observational study will last for six months of active monitoring to collect comprehensive data on cardiovascular health.
CONDITIONS
Brief Title
Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Access to the internet
- Own a smartphone compatible with the Fitbit mobile app
You will not qualify if you...
- Pregnancy
- Having an unstable medical condition
- Unable to provide informed consent
- Mental or cognitive impairment affecting study participation
- Unable to wear the smartwatch due to allergy, amputation, dark wrist tattoos, or other manufacturer restrictions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants wear a Fitbit Charge 6 continuously for six months to collect biometric data. Weekly and monthly online patient-reported outcome measures are also completed throughout this period.
Weekly and monthly online assessments
Duration - Throughout the 6-month study period
Participants undergo clinical cardiovascular health assessments and complete patient-reported outcome measures at baseline, three months, and six months.
3 clinical visits (in-person) at baseline, 3 months, and 6 months
Trial Site Locations
Total: 1 location
1
Beacon Hospital
Dublin, Dublin, Ireland
Actively Recruiting
Research Team
R
Rory Lambe
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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