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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Queen Mary University of London
Sponsor:
Collaborator:
Barts & The London NHS Trust
Information provided by (Responsible Party):
Dr Steffen Erhard Petersen, Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01911910
First received: July 22, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Behavioral: Electronic coaching plus standard care
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Heart Attack Prevention Programme for You (HAPPY) London

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Change in pulse wave velocity (PWV) [ Time Frame: Base line visit, 3 months and 6 months ] [ Designated as safety issue: No ]
    Change in aortic stiffness using a Vicorder device measured in m/s


Secondary Outcome Measures:
  • Change in carotid intima media thickness CIMT [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in quality of life [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ.

  • Pulse Wave Velocity by CMR [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
    Change in aortic stiffness - pulse wave velocity (m/s, CMR)

  • Aortic distensibility by Cardiovascular magnetic resonance (CMR) [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
    Change in LV mass index (g/m2, CMR).

  • Left ventricular ejection fraction by CMR [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
    LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR).

  • Myocardial fibrosis by CMR [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
    Extent and change in diffuse myocardial fibrosis (extracellular volume fraction %, CMR)

  • Diastolic function by CMR [ Time Frame: Baseline and 6 month ] [ Designated as safety issue: No ]
    Diastolic function (strain and strain rate in % and s-1, respectively,CMR).

  • Framingham Risk Score [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Assessment of cardiovascular risk based on the Framingham algorithm

  • QRisk Score [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Assessment of cardiovascular risk score based on the QRisk risk score.

  • Total cholesterol to HDL ratio [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Bloods for lipid profile.

  • LDL cholesterol [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Bloods for lipid profile.

  • Glucose levels [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Fasting glucose bloods

  • hsCRP [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    baseline and change in hsCRP blood test

  • Change in physical activity [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
    Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ

  • change in systolic blood pressure [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  • change in diastolic blood pressure [ Time Frame: baseline, 3 months and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2013
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard care
Usual care that would be provided by the NHS Health Check or equivalent.
Experimental: 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.
Behavioral: 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.
Other Names:
  • Electronic coaching
  • E-Coaching
  • HAPPY E-Coaching

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

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911910

Contacts
Contact: Mohammed Y Khanji, MB BCh BAO 0044 20 7882 6919 m.khanji@qmul.ac.uk
Contact: Steffen E Petersen, MD DPhil 0044 20 7882 6902 s.e.petersen@qmul.ac.uk

Locations
United Kingdom
Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Queen May University of London Recruiting
London, United Kingdom, E2 9JX
Principal Investigator: Steffen E Petersen, MD DPhil         
Sub-Investigator: Mohammed Y Khanji, MB BCh BAO         
Sponsors and Collaborators
Queen Mary University of London
Barts & The London NHS Trust
Investigators
Principal Investigator: Steffen E Petersen, MD DPhil Queen Mary University of London
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Steffen Erhard Petersen, Reader in Advanced Cardiovascular Imaging, Honorary Consultant Cardiologist, Centre Lead for Advanced Cardiovascular Imaging, Queen Mary University of London
ClinicalTrials.gov Identifier: NCT01911910     History of Changes
Other Study ID Numbers: ReDa: 007711
Study First Received: July 22, 2013
Last Updated: July 30, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:
primary prevention
Cardiovascular disease
Cardiovascular magnetic resonance (CMR)
Electronic coaching (e-coaching)

Additional relevant MeSH terms:
Cardiovascular Diseases
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014