Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Cardiovascular Diseases (CVD), Cardiovascular Disease Prevention, Cardiovascular Disease Risk Factor, Coronary Artery Disease (CAD). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Ирландия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study.
Обзор
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.
Подробное описание
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).
Первичные конечные точки
- Cross-Sectional Association of Wearable Biometrics with Cardiovascular Health [Срок оценки: Baseline, Month 3, and Month 6]
- Longitudinal Association of Changes in Wearable Biometrics with Changes in Cardiovascular Health [Срок оценки: Between assessments of cardiovascular health from baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.]
Вторичные конечные точки (4)
- Classification Performance for Life's Essential 8 Tier [Срок оценки: Baseline, Month 3, Month 6.]
- Prediction Accuracy of Change in Life's Essential 8 Score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline through Month 6]
Критерии участия
Критерии включения
- Adults aged 18 years, or older
- Internet access
- Possession of a smartphone compatible with the Fitbit mobile app
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Ирландия · 1 центр
- Beacon Hospital — Dublin
Идентификаторы
NCT: NCT07401550 · BEA0247