NCT01911910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

October 12, 2020

Completed
Last Updated

October 12, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

July 22, 2013

Results QC Date

November 30, 2019

Last Update Submit

September 17, 2020

Conditions

Cardiovascular Disease

Keywords

primary preventionCardiovascular diseaseCardiovascular magnetic resonance (CMR)Electronic coaching (e-coaching)

Outcome Measures

Primary Outcomes (1)

  • Change in Pulse Wave Velocity (PWV)

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

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

Secondary Outcomes (17)

  • Change in Carotid Intima Media Thickness CIMT

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

  • 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

  • Pulse Wave Velocity by CMR

    Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.

  • Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)

    Baseline and 6 month

  • Left Ventricular Mass by CMR

    Baseline and 6 month

  • +12 more secondary outcomes

Study Arms (2)

Standard care

NO INTERVENTION

Usual care that would be provided by the NHS Health Check or equivalent.

Electronic coaching plus standard care

EXPERIMENTAL

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

Interventions

Electronic coaching plus standard careBEHAVIORAL

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.

Also known as: Electronic coaching, E-Coaching, HAPPY E-Coaching
Electronic coaching plus standard care

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Queen May University of London

London, E2 9JX, United Kingdom

Location

Related Publications (2)

  • Khanji MY, Balawon A, Boubertakh R, Hofstra L, Narula J, Hunink M, Pugliese F, Petersen SE. Personalized E-Coaching in Cardiovascular Risk Reduction: A Randomized Controlled Trial. Ann Glob Health. 2019 Jul 12;85(1):107. doi: 10.5334/aogh.2496.

    PMID: 31298823RESULT

  • Khanji MY, Stone IS, Boubertakh R, Cooper JA, Barnes NC, Petersen SE. Chronic Obstructive Pulmonary Disease as a Predictor of Cardiovascular Risk: A Case-Control Study. COPD. 2020 Feb;17(1):81-89. doi: 10.1080/15412555.2019.1694501. Epub 2019 Dec 13.

    PMID: 31833441DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr Mohammed Khanji
Organization
Queen Mary University London/ Barts Health NHS Trsut
m.khanji@qmul.ac.uk
020 7363 8079

Study Officials

  • Steffen E Petersen, MD DPhil

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reader in Advanced Cardiovascular Imaging, Honorary Consultant Cardiologist, Centre Lead for Advanced Cardiovascular Imaging

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 30, 2013

Study Start

June 1, 2013

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 12, 2020

Results First Posted

October 12, 2020

Record last verified: 2020-09

Locations

GB(1)