This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.
Adults aged 18 years, or older
Internet access
Possession of a smartphone compatible with the Fitbit mobile app
Pregnancy
Unstable medical condition
Inability to provide informed consent
Mental or cognitive impairment precluding adherence to study protocol
Participants will primarily include patients with moderate or poor cardiovascular health who have been diagnosed with atherosclerosis and other cardiovascular disease. A smaller proportion of individuals with good cardiovascular health, without diagnosed cardiovascular disease, will also be recruited.
Cohort
Prospective
Not listed
Cross-Sectional Association of Wearable Biometrics with Cardiovascular Health
The strength and direction of the associations between wearable-derived biometric data (e.g., heart rate, sleep, step count) and cardiovascular health, quantified using Life's Essential 8 score and each of its individual components. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health. Clinical cardiovascular assessments will be paired with wearable biometric data from a window of ±2 weeks surrounding the clinical visit date.
Longitudinal Association of Changes in Wearable Biometrics with Changes in Cardiovascular Health
The strength and direction of the association between changes in wearable-derived biometrics and corresponding changes in cardiovascular health, quantified using Life's Essential 8 score and each of its components, assessed over time both within and between individuals. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health.
Classification Performance for Life's Essential 8 Tier
Model classification performance for discriminating between Life's Essential 8 cardiovascular health tiers using wearable-derived biometrics, with and without partial imputation of Life's Essential 8 components which are measurable by point-of-care testing (diet, nicotine use, HbA1c, lipid profile, BMI, blood pressure). Life's Essential 8 tiers are defined as 'Low' (\>50), 'Moderate' (50-79), and 'High' (80-100).
Prediction Accuracy of Change in Life's Essential 8 Score
Statistical model performance in estimating the direction and the magnitude of change in Life's Essential 8 score between assessment timepoints, compared with observed scores. A 10-point change in Life's Essential 8 score is clinically significant.
Cross-Sectional Correlation of Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease
The strength and direction of inter-individual correlation between wearable-derived biometric data and patient-reported outcome measures of alcohol intake, sleep, stress and fatigue, illness, anxiety and depression, physical activity, and quality of life.
Longitudinal Correlation of Weekly and Monthly Changes in Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease
The strength and direction of intra-individual correlation between wearable-derived biometric data and patient-reported outcome measures of alcohol intake, sleep, stress and fatigue, illness, anxiety and depression, physical activity, and quality of life.
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University College Dublin
Lead sponsor
Beacon Hospital, Ireland
Collaborator
