Heart Attack Prevention Programme for You (HAPPY) London
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 402
- 试验地点
- 2
- 主要终点
- Change in Pulse Wave Velocity (PWV)
研究概览
简要总结
Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common and can lead to severe disability or death. Changes in the body leading to heart attacks and strokes usually develop over decades as a result of smoking, diet, and lack of exercise, obesity, diabetes and high blood pressure. Changes in lifestyle and diet can significantly reduce the risk of heart diseases. General Practitioners invite 40 to 74 year-olds who have no known heart disease to take part in the NHS Health Check, which measures each person's individual risk of developing a heart attack or stroke and encourages them in a face-to-face meeting to take part in programmes to help them to give up smoking, lose weight etc. where necessary. In this new clinical trial the investigators will test whether computer-tailored electronic (e)-coaching via email and the internet can help people make the necessary changes in their lifestyle to reduce the risk of heart attacks and strokes.
详细描述
Heart Attack Prevention Programme for You London (HAPPY London) will be conducted as a randomised controlled trial comparing the use of tailored e-coaching in addition to the standard of care vs. standard care alone. Standard care is defined as the care that would be offered by the NHS Health Check programme through the NHS primary care. We will use a range of established and novel cardiovascular markers to determine the clinical and cost effectiveness of e-coaching and gain pathophysiological insight into how lifestyle modifications affect the cardiovascular system. These measures include cardiovascular magnetic resonance imaging (CMR), aortic stiffness parameters, vascular ultrasound and other biomarkers of CV disease risk.
Intervention
The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based on the modified Framingham score and the UK specific QRisk Score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen 'buddies' from family or friends to view their progress will aim to further encourage healthier behaviour.
The study involves the recruitment of 400 adults between the age of 40 and 74 years who have a moderate to high 10-year CV risk score (Estimated 10 year CV risk >10%). Half of the study group will receive use of the e-coaching in addition to standard care allocated randomly stratified according to either moderate (QRisk between 10 and 20%) or high risk (QRisk more than or equal to 20%). The initial screening will take place on the www.happylondon.info web-based 'mini-check' questionnaire. Potential participants will then be seen at a physical screening visit to confirm eligibility. 3 subsequent visits will take place over 6 months; baseline, 3 month and 6 month follow up. A subgroup of the study population (65 from each intervention arm thus totalling 130 participants ) will also have a baseline and follow up cardiovascular magnetic resonance (CMR) imaging. Assessment will be performed using a variety of measures through questionnaires, blood pressure (BP) checks, blood tests, ultrasound scans, oscillometric method to assess pulse wave velocity and pulse wave analysis and CMR multi-parametric scanning.
The primary aim of this study is to assess the clinical effectiveness of individualised, continuous electronic (e-) coaching to support a healthier lifestyle as a primary prevention tool to reduce the CV risk and improve the quality of life in asymptomatic individuals with intermediate to high 10 year CV risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- •Subjects will be between 40 and 74 years of age
- •Subjects will have unrestricted access to the Internet
- •Subjects will be sufficiently fluent in English language.
- •Subjects will have an estimated intermediate to high risk for CV events based on the web-based pre-screening tool (www.happylondon.info), which is based on the nonlaboratory Framingham risk score (>10% 10 year cardiovascular risk)
排除标准
- •History of stroke or transient ischaemic attack (TIA)
- •Cardiac sounding chest pain requiring further investigations
- •Current life threatening conditions other than vascular disease (e.g. very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study
- •Only for subgroup undergoing cardiac contrast-enhanced magnetic resonance studies: Any contraindication to a contrast-enhanced magnetic resonance study, such as known allergies to gadolinium-based contrast agents, severe claustrophobia, pacemakers, defibrillators, etc
结局指标
主要结局
Change in Pulse Wave Velocity (PWV)
时间窗: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in aortic stiffness using a Vicorder device measured in m/s
次要结局
- Change in hsCRP(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Change in Physical Activity(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Change in Carotid Intima Media Thickness CIMT(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Pulse Wave Velocity by CMR(Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.)
- Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)(Baseline and 6 month)
- Left Ventricular Ejection Fraction by CMR(Baseline and 6 month)
- Myocardial Fibrosis by CMR(Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.)
- Change in Diastolic Blood Pressure(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Change in QRisk Score(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Change in Total Cholesterol to HDL Ratio(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Change in Quality of Life(Assessed at Baseline visit, 3 months and 6 months; Data not reported as full analysis not done due to time constraints)
- Change in Glucose Levels(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Left Ventricular Mass by CMR(Baseline and 6 month)
- Diastolic Function by CMR(Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.)
- Change in Framingham Risk Score(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Change in LDL Cholesterol(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
- Change in Systolic Blood Pressure(Assessed at Baseline visit, 3 months and 6 months; Month 6 reported)
研究者
Dr Steffen Erhard Petersen
Reader in Advanced Cardiovascular Imaging, Honorary Consultant Cardiologist, Centre Lead for Advanced Cardiovascular Imaging
Queen Mary University of London