Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Edinburgh
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
Study Overview
Brief Summary
This study will recruit 400 participants who are taking part in the Computed Tomography Coronary Angiography for the Prevention of Myocardial Infarction (SCOT-HEART 2) trial. The investigator will assess diet, activity and habits at the start of the study and 6 months later. This will help us understand the effects taking part in the study may have on lifestyle. In addition, for participants who have CT scans, the investigator will present the results of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to patients.
Detailed Description
This is a sub-study of the SCOT-HEART 2 trial (which aims to determine the best way to prevent heart attacks).
The purpose of this sub-study is to determine the effect of getting information on heart disease risk on lifestyle. At present doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the SCOT-HEART 2 study the investigator will compare this "risk score" to a specialised heart scan (a computed tomography coronary angiogram or CTCA scan). In this study the investigator would like to understand more about the effects of receiving this information about the heart on lifestyle, including effects on smoking, diet and activity.
This study will recruit 400 participants who are taking part in the SCOT-HEART 2 trial. The investigator will assess lifestyle by using a detailed questionnaire which will be done at the start of the study and 6 months later. The investigator will also perform some simple investigations including a carbon monoxide breath test, blood pressure tests and measurements of activity such as step counts. This will help us understand the effects on lifestyle of getting information about a "risk score" or having a CT scan. In addition, for people who have CT scans the investigator will either provide a verbal explanation of the results, as is usual, or show pictures of the heart from the CT scan. This will help us understand how best to explain the results of the CT scan to partipants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Exclusion Criteria
- •MUST BE ENROLLED IN SCOTHEART 2 TRIAL
Outcomes
Primary Outcomes
Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
Time Frame: 6 months
The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%)
Secondary Outcomes
- Smoking cessation(6 months)
- Diabetic control(6 months)
- Exercise(6 months)
- Weight loss(6 months)
- Blood pressure control(6 months)
- Lipid levels(6 months)
- Adherence to medications(6 months)
- Quality of life/Anxiety and Depression(6 months)
- ASSIGN score(6 months)