|
ISRCTN
|
ISRCTN91319318
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
The effect of different cardiovascular risk presentation formats on individuals’ intentions, understanding and emotional affect.
|
|
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
|
|
Serial number at source
|
n/a
|
|
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.
|
|
Lay summary
|
|
|
Ethics approval
|
Ethical approval received from the Medical Dental School Research Ethics Committee (MDSREC), Cardiff University (ref: 09/27)
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Primary prevention, cardiovascular risk assessment, patient education
|
|
Participants - inclusion criteria
|
Male and females aged between 45 and 64 years, who have not been previously diagnosed with coronary heart disease
|
|
Participants - 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
|
|
Anticipated start date
|
01/01/2010
|
|
Anticipated end date
|
30/06/2010
|
|
Status of trial
|
Completed |
|
Patient information material
|
Participant information is found on the first few pages of the website
|
|
Target number of participants
|
800
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
Sub-components of Theory of Planned Behaviour relating to reducing cardiovascular risk:
1. Attitudes
2. Subjective norms
3. Perceived behavioural control
|
|
Sources of funding
|
Cardiff University (UK)
|
|
Trial website
|
http://www.myheartrisk.co.uk
|
|
Publications
|
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20673347
|
|
Contact name
|
Prof
Glyn
Elwyn
|
|
Address
|
Department of Primary Care and Public Health
2nd Floor
Neuadd Meirionnydd
Heath Park
|
|
City/town
|
Cardiff
|
|
Zip/Postcode
|
CF14 4YS
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)29 20 68 71 95
|
|
Fax
|
+44 (0)29 20 68 72 19
|
|
Email
|
ElwynG@cardiff.ac.uk
|
|
Sponsor
|
Cardiff University (UK)
|
|
Address
|
Research and Commercial Division
7th floor, McKenzie House
30 - 36 Newport Road
|
|
City/town
|
Cardiff
|
|
Zip/Postcode
|
CF24 0DE
|
|
Country
|
United Kingdom
|
|
Email
|
DaviesKP2@cf.ac.uk
|
|
Sponsor website:
|
http://www.cardiff.ac.uk/index.html
|
|
Date applied
|
19/11/2009
|
|
Last edited
|
05/11/2010
|
|
Date ISRCTN assigned
|
12/01/2010
|
