Trial Outcomes & Findings for Heart Attack Prevention Programme for You (HAPPY) London (NCT NCT01911910)

Results Overview

Change in aortic stiffness using a Vicorder device measured in m/s

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

402 participants

Primary outcome timeframe

Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Results posted on

2020-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care Usual care that would be provided by the NHS Health Check or equivalent.	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.
Overall Study STARTED	197	205
Overall Study COMPLETED	184	194
Overall Study NOT COMPLETED	13	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart Attack Prevention Programme for You (HAPPY) London

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=197 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=205 Participants 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.	Total n=402 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 4.8 • n=5 Participants	65.1 years STANDARD_DEVIATION 6.3 • n=7 Participants	65.5 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	78 Participants n=7 Participants	149 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	127 Participants n=7 Participants	253 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Change in aortic stiffness using a Vicorder device measured in m/s

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Pulse Wave Velocity (PWV)	-0.25 m/s Standard Deviation 1.73	-0.16 m/s Standard Deviation 1.25

SECONDARY outcome

Timeframe: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

carotid intima media thickness CIMT as measured by ultrasound

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Carotid Intima Media Thickness CIMT	0.01 mm Standard Deviation 0.09	0.01 mm Standard Deviation 0.08

SECONDARY outcome

Timeframe: 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).

Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ.

Outcome measures

Outcome measures
Measure	Standard Care n=162 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=166 Participants 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.
Change in Quality of Life	0.01 score on a scale Standard Deviation 0.06	0 score on a scale Standard Deviation 0.16

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Change in LV mass index (g/m2, CMR).

Outcome measures

Outcome measures
Measure	Standard Care n=42 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=44 Participants 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.
Left Ventricular Mass by CMR	-1.42 g/m2 Standard Deviation 8.36	-1.73 g/m2 Standard Deviation 9.4

SECONDARY outcome

Timeframe: Baseline and 6 month

Population: Change in the ejection fraction based on the moving images derived from the CMR scan.

LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR).

Outcome measures

Outcome measures
Measure	Standard Care n=42 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=44 Participants 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.
Left Ventricular Ejection Fraction by CMR	-0.45 % change in ejection fraction Standard Deviation 5.41	-0.88 % change in ejection fraction Standard Deviation 6.29

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Framingham Risk Score	-1.37 % risk over 10 years Standard Deviation 5.68	-1.23 % risk over 10 years Standard Deviation 4.47

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in QRisk Score	-0.05 % risk over 10-years Standard Deviation 2.64	0.2 % risk over 10-years Standard Deviation 2.52

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Total Cholesterol to HDL Ratio	-0.11 ratio Standard Deviation 0.66	-0.04 ratio Standard Deviation 0.55

SECONDARY outcome

Timeframe: 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.

Bloods for lipid profile. Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in LDL Cholesterol	-0.2 mmol/L Standard Deviation 0.77	-0.16 mmol/L Standard Deviation 0.68

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Glucose Levels	-0.27 mmol/L Standard Deviation 0.87	-0.29 mmol/L Standard Deviation 0.87

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in hsCRP	0 mg/L Standard Deviation 7.7	-0.26 mg/L Standard Deviation 8.19

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Physical Activity	8.45 minutes per day over 5 days Standard Deviation 118.87	25.1 minutes per day over 5 days Standard Deviation 132.85

SECONDARY outcome

Timeframe: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Change in systolic blood pressure measured during sitting position

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Systolic Blood Pressure	-1.69 mmHg Standard Deviation 13.91	-3.18 mmHg Standard Deviation 12.2

SECONDARY outcome

Timeframe: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported

Change in diastolic blood pressure measure during sitting position.

Outcome measures

Outcome measures
Measure	Standard Care n=183 Participants Usual care that would be provided by the NHS Health Check or equivalent.	Electronic Coaching Plus Standard Care n=194 Participants 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.
Change in Diastolic Blood Pressure	-2.08 mmHg Standard Deviation 6.85	-2.37 mmHg Standard Deviation 6.41

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electronic Coaching Plus Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Mohammed Khanji

Queen Mary University London/ Barts Health NHS Trsut

Phone: 020 7363 8079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place