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Heart Attack Prevention Programme for You (HAPPY) London (HAPPYLondon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01911910
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Barts & The London NHS Trust
Information provided by (Responsible Party):
Dr Steffen Erhard Petersen, Queen Mary University of London

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Cardiovascular Disease
Intervention Behavioral: Electronic coaching plus standard care
Enrollment 402
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description Usual care that would be provided by the NHS Health Check or equivalent.

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.

Period Title: Overall Study
Started 197 205
Completed 184 194
Not Completed 13 11
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care Total
Hide Arm/Group Description Usual care that would be provided by the NHS Health Check or equivalent.

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 of all reporting groups
Overall Number of Baseline Participants 197 205 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 197 participants 205 participants 402 participants
65.9  (4.8) 65.1  (6.3) 65.5  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 205 participants 402 participants
Female
71
  36.0%
78
  38.0%
149
  37.1%
Male
126
  64.0%
127
  62.0%
253
  62.9%
1.Primary Outcome
Title Change in Pulse Wave Velocity (PWV)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: m/s
-0.25  (1.73) -0.16  (1.25)
2.Secondary Outcome
Title Change in Carotid Intima Media Thickness CIMT
Hide Description carotid intima media thickness CIMT as measured by ultrasound
Time Frame Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: mm
0.01  (0.09) 0.01  (0.08)
3.Secondary Outcome
Title Change in Quality of Life
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 162 166
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.01  (0.06) 0  (0.16)
4.Secondary Outcome
Title Pulse Wave Velocity by CMR
Hide Description 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.
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)
Hide Description

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
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Left Ventricular Mass by CMR
Hide Description Change in LV mass index (g/m2, CMR).
Time Frame Baseline and 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 42 44
Mean (Standard Deviation)
Unit of Measure: g/m2
-1.42  (8.36) -1.73  (9.4)
7.Secondary Outcome
Title Left Ventricular Ejection Fraction by CMR
Hide Description LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR).
Time Frame Baseline and 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
Change in the ejection fraction based on the moving images derived from the CMR scan.
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 42 44
Mean (Standard Deviation)
Unit of Measure: % change in ejection fraction
-0.45  (5.41) -0.88  (6.29)
8.Secondary Outcome
Title Myocardial Fibrosis by CMR
Hide Description 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.
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Diastolic Function by CMR
Hide Description

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.
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change in Framingham Risk Score
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: % risk over 10 years
-1.37  (5.68) -1.23  (4.47)
11.Secondary Outcome
Title Change in QRisk Score
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: % risk over 10-years
-0.05  (2.64) 0.2  (2.52)
12.Secondary Outcome
Title Change in Total Cholesterol to HDL Ratio
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement.
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: ratio
-0.11  (0.66) -0.04  (0.55)
13.Secondary Outcome
Title Change in LDL Cholesterol
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.2  (0.77) -0.16  (0.68)
14.Secondary Outcome
Title Change in Glucose Levels
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.27  (0.87) -0.29  (0.87)
15.Secondary Outcome
Title Change in hsCRP
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Change in the hsCRP level though a blood test. Negative value suggests an improvement.
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: mg/L
0  (7.7) -0.26  (8.19)
16.Secondary Outcome
Title Change in Physical Activity
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: minutes per day over 5 days
8.45  (118.87) 25.1  (132.85)
17.Secondary Outcome
Title Change in Systolic Blood Pressure
Hide Description Change in systolic blood pressure measured during sitting position
Time Frame Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: mmHg
-1.69  (13.91) -3.18  (12.2)
18.Secondary Outcome
Title Change in Diastolic Blood Pressure
Hide Description Change in diastolic blood pressure measure during sitting position.
Time Frame Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description:
Usual care that would be provided by the NHS Health Check or equivalent.

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 Number of Participants Analyzed 183 194
Mean (Standard Deviation)
Unit of Measure: mmHg
-2.08  (6.85) -2.37  (6.41)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care Electronic Coaching Plus Standard Care
Hide Arm/Group Description Usual care that would be provided by the NHS Health Check or equivalent.

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.

All-Cause Mortality
Standard Care Electronic Coaching Plus Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/197 (0.00%)   0/205 (0.00%) 
Hide Serious Adverse Events
Standard Care Electronic Coaching Plus Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/197 (0.00%)   0/205 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Care Electronic Coaching Plus Standard Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/197 (0.00%)   0/205 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Mohammed Khanji
Organization: Queen Mary University London/ Barts Health NHS Trsut
Phone: 020 7363 8079
EMail: m.khanji@qmul.ac.uk
Layout table for additonal information
Responsible Party: Dr Steffen Erhard Petersen, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01911910    
Other Study ID Numbers: ReDa: 007711
First Submitted: July 22, 2013
First Posted: July 30, 2013
Results First Submitted: November 30, 2019
Results First Posted: October 12, 2020
Last Update Posted: October 12, 2020