Plain English Summary
Not provided at time of registration
Trial website
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 measure
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 (if study stopped)
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
Funders
Funder type
University/education
Funder name
Cardiff University (UK)
Alternative name(s)
Prifysgol Caerdydd
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20673347
Publication citations
-
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.