Cardiovascular Disease
Conditions
Keywords
primary prevention, Cardiovascular disease, Cardiovascular magnetic resonance (CMR), Electronic coaching (e-coaching)
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?
Interventions
BEHAVIORALElectronic coaching plus standard care
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.
Sponsors
Barts & The London NHS Trust
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulse Wave Velocity (PWV) | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Change in aortic stiffness using a Vicorder device measured in m/s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ. |
| Pulse Wave Velocity by CMR | Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations. | Change in aortic stiffness as measured by CMR derived aortic pulse wave velocity measured in m/s |
| Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR) | Baseline and 6 month | CMR will be performed on 65 participants in the treatment and 65 in the standard care group. Change in aortic stiffness - aortic distensibility (mmHg-1, CMR)). |
| Left Ventricular Mass by CMR | Baseline and 6 month | Change in LV mass index (g/m2, CMR). |
| Left Ventricular Ejection Fraction by CMR | Baseline and 6 month | LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR). |
| 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. | Extent and change in diffuse myocardial fibrosis (extracellular volume fraction measured as a %, derived from CMR imaging) |
| 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. | Diastolic function (strain and strain rate in % and s-1, respectively derived from CMR imaging data). This is a measure of how stiff the main chamber of the heart is. The software to analyse these data will be available in the future. The raw images from the scan will be used for future analysis once software for this assessment is developed. Our group is working on developing this tool. |
| Change in Framingham Risk Score | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Assessment of cardiovascular risk based on the Framingham algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of 10-year cardiovascular risk score based on the Framingham population derived algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. |
| Change in Carotid Intima Media Thickness CIMT | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | carotid intima media thickness CIMT as measured by ultrasound |
| Change in Total Cholesterol to HDL Ratio | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Ratio of Total cholesterol to HDL from blood test for lipid profile. Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement. |
| Change in LDL Cholesterol | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Bloods for lipid profile. Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement. |
| Change in Glucose Levels | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Fasting glucose bloods. This is an assessment for presence of diabetes and control of blood sugar levels on the day of the test. Change in the blood glucose level as measure on the day of the visit as a measure of blood sugar level. Negative value would suggest an improvement. |
| Change in hsCRP | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | baseline and change in hsCRP blood test. hsCRP is measured through a blood test and is a marker of inflammation. Change in the hsCRP level though a blood test. Negative value suggests an improvement. |
| Change in Physical Activity | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ |
| Change in Systolic Blood Pressure | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Change in systolic blood pressure measured during sitting position |
| Change in Diastolic Blood Pressure | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Change in diastolic blood pressure measure during sitting position. |
| Change in QRisk Score | Assessed at Baseline visit, 3 months and 6 months; Month 6 reported | Assessment of cardiovascular risk score based on the QRisk risk score. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of cardiovascular risk score based on the UK standardised using the QRISK2 algorithm (www.qrisk.org). Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Usual care that would be provided by the NHS Health Check or equivalent. | 197 |
| Electronic Coaching Plus Standard Care Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour.
Electronic coaching plus standard care: 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. | 205 |
| Total | 402 |
Baseline characteristics
| Characteristic | Standard Care | Electronic Coaching Plus Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 4.8 | 65.1 years STANDARD_DEVIATION 6.3 | 65.5 years STANDARD_DEVIATION 5.6 |
| Sex: Female, Male Female | 71 Participants | 78 Participants | 149 Participants |
| Sex: Female, Male Male | 126 Participants | 127 Participants | 253 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 197 | 0 / 205 |
| other Total, other adverse events | 0 / 197 | 0 / 205 |
| serious Total, serious adverse events | 0 / 197 | 0 / 205 |
Outcome results
Primary
Change in Pulse Wave Velocity (PWV)
Change in aortic stiffness using a Vicorder device measured in m/s
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Pulse Wave Velocity (PWV) | -0.25 m/s | Standard Deviation 1.73 |
| Electronic Coaching Plus Standard Care | Change in Pulse Wave Velocity (PWV) | -0.16 m/s | Standard Deviation 1.25 |
Secondary
Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)
CMR will be performed on 65 participants in the treatment and 65 in the standard care group. Change in aortic stiffness - aortic distensibility (mmHg-1, CMR)).
Time frame: Baseline and 6 month
Secondary
Change in Carotid Intima Media Thickness CIMT
carotid intima media thickness CIMT as measured by ultrasound
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Carotid Intima Media Thickness CIMT | 0.01 mm | Standard Deviation 0.09 |
| Electronic Coaching Plus Standard Care | Change in Carotid Intima Media Thickness CIMT | 0.01 mm | Standard Deviation 0.08 |
Secondary
Change in Diastolic Blood Pressure
Change in diastolic blood pressure measure during sitting position.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Diastolic Blood Pressure | -2.08 mmHg | Standard Deviation 6.85 |
| Electronic Coaching Plus Standard Care | Change in Diastolic Blood Pressure | -2.37 mmHg | Standard Deviation 6.41 |
Secondary
Change in Framingham Risk Score
Assessment of cardiovascular risk based on the Framingham algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of 10-year cardiovascular risk score based on the Framingham population derived algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Population: Assessment of 10-year cardiovascular risk score based on the Framingham population derived algorithm.~Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Framingham Risk Score | -1.37 % risk over 10 years | Standard Deviation 5.68 |
| Electronic Coaching Plus Standard Care | Change in Framingham Risk Score | -1.23 % risk over 10 years | Standard Deviation 4.47 |
Secondary
Change in Glucose Levels
Fasting glucose bloods. This is an assessment for presence of diabetes and control of blood sugar levels on the day of the test. Change in the blood glucose level as measure on the day of the visit as a measure of blood sugar level. Negative value would suggest an improvement.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Population: Change in the blood glucose level as measure on the day of the visit as a measure of blood sugar level. Negative value would suggest an improvement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Glucose Levels | -0.27 mmol/L | Standard Deviation 0.87 |
| Electronic Coaching Plus Standard Care | Change in Glucose Levels | -0.29 mmol/L | Standard Deviation 0.87 |
Secondary
Change in hsCRP
baseline and change in hsCRP blood test. hsCRP is measured through a blood test and is a marker of inflammation. Change in the hsCRP level though a blood test. Negative value suggests an improvement.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Population: Change in the hsCRP level though a blood test. Negative value suggests an improvement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in hsCRP | 0 mg/L | Standard Deviation 7.7 |
| Electronic Coaching Plus Standard Care | Change in hsCRP | -0.26 mg/L | Standard Deviation 8.19 |
Secondary
Change in LDL Cholesterol
Bloods for lipid profile. Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Population: Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in LDL Cholesterol | -0.2 mmol/L | Standard Deviation 0.77 |
| Electronic Coaching Plus Standard Care | Change in LDL Cholesterol | -0.16 mmol/L | Standard Deviation 0.68 |
Secondary
Change in Physical Activity
Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Physical Activity | 8.45 minutes per day over 5 days | Standard Deviation 118.87 |
| Electronic Coaching Plus Standard Care | Change in Physical Activity | 25.1 minutes per day over 5 days | Standard Deviation 132.85 |
Secondary
Change in QRisk Score
Assessment of cardiovascular risk score based on the QRisk risk score. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome. Assessment of cardiovascular risk score based on the UK standardised using the QRISK2 algorithm (www.qrisk.org). Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Population: Assessment of cardiovascular risk score based on the UK standardised using the QRISK2 algorithm (www.qrisk.org).~Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in QRisk Score | -0.05 % risk over 10-years | Standard Deviation 2.64 |
| Electronic Coaching Plus Standard Care | Change in QRisk Score | 0.2 % risk over 10-years | Standard Deviation 2.52 |
Secondary
Change in Quality of Life
Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Data not reported as full analysis not done due to time constraints
Population: Change in quality of life using the visual analogue scale (VAS) from the EQ-5D questionnaire. Not all participants completed both the baseline and 6-month follow-up, therefore resulting in a lower number analysed compared to other quantitative measures.The highest VAS is score was 1 (best values, highest quality of life).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Quality of Life | 0.01 score on a scale | Standard Deviation 0.06 |
| Electronic Coaching Plus Standard Care | Change in Quality of Life | 0 score on a scale | Standard Deviation 0.16 |
Secondary
Change in Systolic Blood Pressure
Change in systolic blood pressure measured during sitting position
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Systolic Blood Pressure | -1.69 mmHg | Standard Deviation 13.91 |
| Electronic Coaching Plus Standard Care | Change in Systolic Blood Pressure | -3.18 mmHg | Standard Deviation 12.2 |
Secondary
Change in Total Cholesterol to HDL Ratio
Ratio of Total cholesterol to HDL from blood test for lipid profile. Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement.
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Population: Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Change in Total Cholesterol to HDL Ratio | -0.11 ratio | Standard Deviation 0.66 |
| Electronic Coaching Plus Standard Care | Change in Total Cholesterol to HDL Ratio | -0.04 ratio | Standard Deviation 0.55 |
Secondary
Diastolic Function by CMR
Diastolic function (strain and strain rate in % and s-1, respectively derived from CMR imaging data). This is a measure of how stiff the main chamber of the heart is. The software to analyse these data will be available in the future. The raw images from the scan will be used for future analysis once software for this assessment is developed. Our group is working on developing this tool.
Time frame: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Secondary
Left Ventricular Ejection Fraction by CMR
LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR).
Time frame: Baseline and 6 month
Population: Change in the ejection fraction based on the moving images derived from the CMR scan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Left Ventricular Ejection Fraction by CMR | -0.45 % change in ejection fraction | Standard Deviation 5.41 |
| Electronic Coaching Plus Standard Care | Left Ventricular Ejection Fraction by CMR | -0.88 % change in ejection fraction | Standard Deviation 6.29 |
Secondary
Left Ventricular Mass by CMR
Change in LV mass index (g/m2, CMR).
Time frame: Baseline and 6 month
Population: CMR data were collected as part of a pilot data in a subgroup of the total number of participants enrolled in the study. Further analysis will take place once funding for further fellow who will be able to perform the detailed software analysis. The data will forms ongoing work.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Left Ventricular Mass by CMR | -1.42 g/m2 | Standard Deviation 8.36 |
| Electronic Coaching Plus Standard Care | Left Ventricular Mass by CMR | -1.73 g/m2 | Standard Deviation 9.4 |
Secondary
Myocardial Fibrosis by CMR
Extent and change in diffuse myocardial fibrosis (extracellular volume fraction measured as a %, derived from CMR imaging)
Time frame: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Secondary
Pulse Wave Velocity by CMR
Change in aortic stiffness as measured by CMR derived aortic pulse wave velocity measured in m/s
Time frame: Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.