Clinical trial NCT01911910: Heart Attack Prevention Programme for You (HAPPY) London
Official title: Heart Attack Prevention Programme for You (HAPPY) London
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: primary prevention
Cardiovascular disease
Cardiovascular magnetic resonance (CMR)
Electronic coaching (e-coaching)
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
First posted: 2013-07-30
Enrollment: 402
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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?

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Pulse Wave Velocity (PWV)
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Secondary outcomes:
measure: Change in Carotid Intima Media Thickness CIMT
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in Quality of Life
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Data not reported as full analysis not done due to time constraints
measure: Pulse Wave Velocity by CMR
timeFrame: Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
measure: Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)
timeFrame: Baseline and 6 month
measure: Left Ventricular Mass by CMR
timeFrame: Baseline and 6 month
measure: Left Ventricular Ejection Fraction by CMR
timeFrame: Baseline and 6 month
measure: Myocardial Fibrosis by CMR
timeFrame: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
measure: Diastolic Function by CMR
timeFrame: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
measure: Change in Framingham Risk Score
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in QRisk Score
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in Total Cholesterol to HDL Ratio
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in LDL Cholesterol
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in Glucose Levels
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in hsCRP
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in Physical Activity
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in Systolic Blood Pressure
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
measure: Change in Diastolic Blood Pressure
timeFrame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Queen May University of London
Study officials:
affiliation: Queen Mary University of London
name: Steffen E Petersen, MD DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khanji MY, Balawon A, Boubertakh R, Hofstra L, Narula J, Hunink M, Pugliese F, Petersen SE. Personalized E-Coaching in Cardiovascular Risk Reduction: A Randomized Controlled Trial. Ann Glob Health. 2019 Jul 12;85(1):107. doi: 10.5334/aogh.2496.
citation: Khanji MY, Stone IS, Boubertakh R, Cooper JA, Barnes NC, Petersen SE. Chronic Obstructive Pulmonary Disease as a Predictor of Cardiovascular Risk: A Case-Control Study. COPD. 2020 Feb;17(1):81-89. doi: 10.1080/15412555.2019.1694501. Epub 2019 Dec 13.