The effect of different cardiovascular risk presentation formats on individuals intentions, understanding and emotional affect.
| ISRCTN | ISRCTN91319318 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91319318 |
| Secondary identifying numbers | n/a |
- Submission date
- 19/11/2009
- Registration date
- 12/01/2010
- Last edited
- 05/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Glyn Elwyn
Scientific
Scientific
Department of Primary Care and Public Health
2nd Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
| Phone | +44 (0)29 20 68 71 95 |
|---|---|
| ElwynG@cardiff.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Participant information is found on the first few pages of the website |
| 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 |
| Study acronym | myheartrisk |
| Study objectives | 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(s) | Ethical approval received from the Medical Dental School Research Ethics Committee (MDSREC), Cardiff University (ref: 09/27) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2010 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 800 |
| Key inclusion criteria | Male and females aged between 45 and 64 years, who have not been previously diagnosed with coronary heart disease |
| Key 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 |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Department of Primary Care and Public Health
Cardiff
CF14 4YS
United Kingdom
CF14 4YS
United Kingdom
Sponsor information
Cardiff University (UK)
University/education
University/education
Research and Commercial Division
7th floor, McKenzie House
30 - 36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| DaviesKP2@cf.ac.uk | |
| Website | http://www.cardiff.ac.uk/index.html |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
University/education
Cardiff University (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 30/07/2010 | Yes | No |
