Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases (CVD), Cardiovascular Disease Prevention, Cardiovascular Disease Risk Factor, Coronary Artery Disease (CAD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study.
Overview
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.
Detailed description
Participants will be provided with a Fitbit Charge 6 to wear continuously for six-months. These wearable data will be collected via Fitabase (Small Steps Labs LLC) for the duration of the study.
At baseline, mid-point (three months), and end-point (six months), participants will undergo a clinical cardiovascular health assessment and Life's Essential 8 score will be calculated. Life's Essential 8, established by the American Heart Association, is a composite metric comprising four Health Behaviours and four Health Factors, and provides individuals with a score ranging from 0 (poor health) to 100 (optimal health). Life's Essential 8 health tiers are defined as 'Low' (\<50), 'Moderate' (50-79), and 'High' (80-100). Alongside Life's Essential 8, during each clinical assessment, four patient-reported outcome measures will be collected: EQ-5D-5L, International Physical Activity Questionnaire, Patient Health Questionnaire 9, and Generalized Anxiety Disorder 7.
Participants will also complete patient-reported outcome measures online once per week for the duration of the study. These include the Modified Wisconsin Upper Respiratory Symptom Scale (WURSS), Alcohol Intake Questionnaire, Single-Item Sleep Quality Scale (SQS), Patient Health Questionnaire 4 (PHQ-4), and the two-item Modified Hooper Questionnaire for stress and fatigue. Once per month they will complete the Pittsburgh Sleep Quality Index (PSQI).
Primary outcome measures
- Cross-Sectional Association of Wearable Biometrics with Cardiovascular Health [Time frame: Baseline, Month 3, and Month 6]
- Longitudinal Association of Changes in Wearable Biometrics with Changes in Cardiovascular Health [Time frame: Between assessments of cardiovascular health from baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.]
Secondary outcome measures (4)
- Classification Performance for Life's Essential 8 Tier [Time frame: Baseline, Month 3, Month 6.]
- Prediction Accuracy of Change in Life's Essential 8 Score [Time frame: From baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.]
- Cross-Sectional Correlation of Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease [Time frame: Baseline, Month 3, Month 6.]
- Longitudinal Correlation of Weekly and Monthly Changes in Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease [Time frame: Baseline through Month 6]
Eligibility criteria
Inclusion criteria
- Adults aged 18 years, or older
- Internet access
- Possession of a smartphone compatible with the Fitbit mobile app
Exclusion criteria
- Pregnancy
- Unstable medical condition
- Inability to provide informed consent
- Mental or cognitive impairment precluding adherence to study protocol
- Smartwatch cannot be worn, (e.g., allergic reactions), or cannot be worn in accordance with manufacturer guidelines (e.g., amputation, dark tattoos at wrist)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Ireland · 1 center
- Beacon Hospital — Dublin
Identifiers
NCT: NCT07401550 · BEA0247