Condition category
Circulatory System
Date applied
19/11/2009
Date assigned
12/01/2010
Last edited
05/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.myheartrisk.co.uk

Contact information

Type

Scientific

Primary contact

Prof Glyn Elwyn

ORCID ID

Contact details

Department of Primary Care and Public Health
2nd Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)29 20 68 71 95
ElwynG@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

n/a

Study information

Scientific title

The effect of different cardiovascular risk presentation formats on individuals’ intentions, understanding and emotional affect: A Randomised Controlled Trial using a web-based risk formatter

Acronym

myheartrisk

Study hypothesis

The overall aim of this trial is to compare the effects of different graphical cardiovascular risk
presentation formats on individuals' intention to reduce risk, understanding of risk information, emotional affect and worry about future heart disease.

The study will be conducted remotely, amongst individuals without established cardiovascular disease, using an on-line cardiovascular risk assessment and questionnaires.

Ethics approval

Ethical approval received from the Medical Dental School Research Ethics Committee (MDSREC), Cardiff University (ref: 09/27)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Participant information is found on the first few pages of the website

Condition

Primary prevention, cardiovascular risk assessment, patient education

Intervention

All respondents access the website remotely. They will be randomly assigned to one of four conditions and will have their risk assessed by answering questions about their risk factors. They will be presented with their 10-year risk of having a coronary heart disease event in one of three formats. All respondents will be asked to complete a post-intervention questionnaire.

Control groups: There are two control groups. The first control comprises a pre-intervention
questionnaire and presents risk in a bar graph format. The second control group presents risk in a bar graph format without the pre-intervention questionnaire. These two control groups are to account for the potential Hawthorne effect of the four groups, and enable a comparison of responses between those who are asked to think about their cardiovascular risk before viewing actual risk, against those who are not.

Intervention groups: The two intervention groups present risk in either a pictogram or metonym format.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

All outcomes measured by post-intervention questionnaire.
Emotional affect and worry about future heart disease will be assessed at baseline as well.

1. Intention to change behaviour
2. Understanding of risk information
3. Emotional affect
4. Worry about future heart disease

Secondary outcome measures

Sub-components of Theory of Planned Behaviour relating to reducing cardiovascular risk:
1. Attitudes
2. Subjective norms
3. Perceived behavioural control

Overall trial start date

01/01/2010

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Male and females aged between 45 and 64 years, who have not been previously diagnosed with coronary heart disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Below the age of 45 or over the age of 64 years
2. Previous diagnosis of cardiovascular disease
3. Inability to read English
4. Inability to access to a computer with the internet
5. Inadequate IT skills

Recruitment start date

01/01/2010

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Care and Public Health
Cardiff
CF14 4YS
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

Research and Commercial Division
7th floor
McKenzie House
30 - 36 Newport Road
Cardiff
CF24 0DE
United Kingdom
DaviesKP2@cf.ac.uk

Sponsor type

University/education

Website

http://www.cardiff.ac.uk/index.html

Funders

Funder type

University/education

Funder name

Cardiff University (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20673347

Publication citations

  1. Results

    Waldron CA, Gallacher J, van der Weijden T, Newcombe R, Elwyn G, The effect of different cardiovascular risk presentation formats on intentions, understanding and emotional affect: a randomised controlled trial using a web-based risk formatter (protocol)., BMC Med Inform Decis Mak, 2010, 10, 41, doi: 10.1186/1472-6947-10-41.

Additional files

Editorial Notes