Wearable Health Data to Investigate Long-term Cardiovascular and Behavioral Health Outcomes in COVID-19 Patients After Discharge: The WEAICOR Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of major cardiovascular events
研究概览
简要总结
This is an observational COVID-19 study that uses wearable health monitoring technology to follow COVID-19 positive individuals to monitor persistent symptoms and any potential long-term complications or cardiovascular and behavioral impacts from the disease.
详细描述
Participants will wear a Biostrap wristband device that captures high-fidelity, raw photoplethysmography (PPG) waveforms and collects important indicators of heart and mental health, including heart rate, heart rate variability, pulse points, oxygen saturation and sleep patterns. Biometric data will be collected and participants will be alerted if any measurements are outside their normal range.
Researchers are recruiting 200 participants who were diagnosed with COVID-19.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Positive COVID-19 diagnosis
- •Ages 18 to 120
- •Access to WiFi
排除标准
- •Negative COVID-19 diagnosis
- •Age younger than 18 and older than 120
- •Lack of access to WiFi
结局指标
主要结局
Incidence of major cardiovascular events
时间窗: 12 Months
Including arrhythmia occurrence or recurrence, congestive heart failure, myocardial infarction, cardiomyopathy and ischemic stroke.
Mental health effect of COVID-19 measured by incidence of Generalized Anxiety Disorder (GAD) using Generalized Anxiety Disorder 7-item (GAD-7) Scale
时间窗: 12 Months
Generalized Anxiety Disorder 7-item (GAD-7) Scale includes 7 questions to be answered by the patient, each answer is scored from 0 to 3, and the scale range is from 0 to 21, with a higher number representing more severe GAD level
Mental health effect of COVID-19 measured by incidence of depression using Beck Depression Fast Screen Scale
时间窗: 12 Months
Beck Depression Fast Screen Scale includes 21 questions to be answered by the patient scored from 0 to 3, and the scale range is from 0 to above 40, with a higher number representing more severe depression level
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of drugs survey
时间窗: 12 Months
Baseline use of drugs survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased drug use
Incidence of atrial arrhythmia
时间窗: 12 Months
Including atrial fibrillation, atrial flutter, atrial tachycardia
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of alcohol survey
时间窗: 12 Months
Baseline use of alcohol survey includes ten questions to be answered by the patient scored from 0 to 4 with a higher number representing increased alcohol consumption
Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of nicotine products survey
时间窗: 12 Months
Baseline use of nicotine products survey includes 4 questions to be answered by the patient to find out which nicotine products the patient is using if any and how many cigarettes they're smoking per day
Mental health effect of COVID-19 measured by incidence of Post Traumatic Stress Syndrome (PTSD) using the Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) scale
时间窗: 12 Months
Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) Scale includes 20 questions to be answered by the patient scored from 1 to 5. Total symptom severity score (ranging 0-80) can be obtained by summing the scores for each of the 20 items. Higher number represents more likely that the patient has PTSD.
次要结局
未报告次要终点