Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID07401550

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Access to the internet
  • Own a smartphone compatible with the Fitbit mobile app
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Diagnostic Evaluation

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

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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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