The Heart Hive COVID-19 Study: A Longitudinal Observational Study of the Impact and Clinical Outcomes of the COVID-19 Pandemic on Individuals With Heart Muscle Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.
研究概览
简要总结
All patients with heart disease should have the opportunity to participate in research into their condition, to advance knowledge and treatment.
The HeartHive COVID-19 study is an international online pilot observational cohort study evaluating the impact and clinical outcomes of the COVID-19 pandemic on subjects enrolled in the HeartHive.
Cardiomyopathies are progressive diseases, and there is a need to better understand what factors affect the chances of developing cardiomyopathy, and how the condition progresses.
The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural changes and the psychosocial ramifications of the pandemic are required to better understand the health needs of this population during these unprecedented circumstances and to adapt clinical services to meet these.
The study will entail completing serial online surveys during the pandemic.
This study uses The Heart Hive - an international, online registry of patients with self-reported clinically diagnosed cardiomyopathy, and people without heart disease. Participants enrol and upload their own data through the website. It is the second research study that will be offered to registry participants and delivered through The Heart Hive platform.
详细描述
The impact of the COVID-19 pandemic on patients with cardiomyopathy has not been explored and represents a critical unmet need. Insights into exposure, healthcare outcomes, behavioural changes and the psychosocial ramifications of the pandemic are required to better understand the health needs of this population during these unprecedented circumstances and to adapt clinical services to meet these.
The requirements for the population to limit social interaction and stay at home significantly limits conventional research approaches to studying the effect of the pandemic on patients. The Heart Hive platform circumnavigates this by offering an online mechanism to gain insight into the effect of the pandemic in a pre-assembled cohort of patients rapidly and in real-time as the pandemic evolves without any risk to patients.
This study is framed around the following hypotheses:
- Patients with cardiomyopathy who contract COVID-19 are at greater risk or death or hospitalisation than subjects without heart disease.
- Patients with cardiomyopathy perceive themselves to be at enhanced risk and are more likely to be following national recommendations on social restriction measures than subjects without heart disease.
- Patients with cardiomyopathy have experienced interruption to the delivery of their usual cardiology/cardiomyopathy clinical service as a result of the pandemic.
- Patients with cardiomyopathy are less likely to seek medical help due to fear of contracting COVID-19.
- The psychological impact of the pandemic is greater in patients with cardiomyopathy than in subjects without heart disease.
Primary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (age 18 and over) Males or Females
- •Capacity to provide informed consent
- •Subjects with either:
- •A self-reported confirmed diagnosis of cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, restrictive cardiomyopathy, left ventricular non-compaction cardiomyopathy) Or
- •No self-reported history of heart disease
- •Note: Pregnant women are eligible. This study is observational and entirely separate from clinical care.
排除标准
- •Patients who lack capacity to consent for themselves Vulnerable groups (e.g. those under 18, prisoners, those in a dependent relationship, the mentally ill)
- •Although usually considered a vulnerable group, pregnant women are eligible for this study which is observational and entirely separate from clinical care.
- •Patients with a confirmed history of coronary artery disease:
- •who have been informed by their treating physician that their cardiomyopathy is secondary to their coronary artery disease, or
- •who have undergone previous percutaneous coronary intervention or coronary bypass surgery History of primary valvular heart disease or congenital heart disease Severe, untreated or untreatable hypertension (systolic blood pressures routinely >180 mm Hg and/or diastolic blood pressures >120 mm Hg)
结局指标
主要结局
Qualitative measures of exposure, perception of risk, behaviour, and experience during the COVID-19 pandemic.
时间窗: 2 years
Collected from serial online surveys
Health Outcomes
时间窗: 2 years
Hospital admissions and deaths due to COVID-19, incidents of major adverse cardiovascular events
次要结局
未报告次要终点