Heart Attack Prevention Programme for You (HAPPY) London
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Myocardial Infarction
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Other questions that we aim to answer are:

        1. Is computer-tailored e-coaching cost-effective in the short-term (clinical trial period)
           and during the long-term (decision analysis modelling)

        2. What are the associations of personality traits, economic preferences, and sociocultural
           factors with the achieved lifestyle modifications and changes in the cardiovascular
           phenotype?

        3. What is the relationship between changes observed in markers derived from our
           multi-parametric cardiovascular magnetic resonance imaging protocols following lifestyle
           changes?

        4. How frequent are silent myocardial infarctions in a typical NHS Health Check population?

        5. Do treatment effects differ between ethnic groups?
    

Intervention name(s): Electronic coaching plus standard care
Intervention type(s): Behavioral
Intervention description(s): The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham 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 family and friends to view their progress will aim to further encourage healthier behaviour.
Other intervention name(s): Electronic coaching; E-Coaching; HAPPY E-Coaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: primary prevention; Cardiovascular disease; Cardiovascular magnetic resonance (CMR); Electronic coaching (e-coaching)