Effect of the SCOT-HEART 2 Trial on Lifestyle and Risk Factor Modification.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MUST BE ENROLLED IN SCOTHEART 2 TRIAL
排除标准
- •MUST BE ENROLLED IN SCOTHEART 2 TRIAL
研究组 & 干预措施
ASSIGN score
The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments.
Patients randomised to standard care with ASSIGN score alone (n=200) will be invited back approximately 6 months after baseline assessment. The detailed questionnaire, breath test, blood pressure monitoring, and 2-week activity monitor will be repeated. Bloods will be retaken to look at change in lipid levels and HbA1c where appropriate - no more than 30mls will be required.
CTCA - visual report
Those in the CTCA group will be further randomised into review with or without CT images.
The review WITH images (VISUAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.
干预措施: Delivery of CT scan results (Other)
CTCA - verbal report
The baseline assessment will be completed on the same day as consent is gained. Every patients will complete a comprehensive assessment including questionnaires and objective assessments.
Those in the CTCA group will be further randomised into review with or without CT images.
The review WITHOUT images (VERBAL REPORT N=100) group will have results delivered by the principal investigator (a trained Cardiology Registrar) to ensure a standardised approach to relaying information. These results will be preliminary and focused only on whether the patient has evidence of coronary disease or not. A full report describing the extent of coronary disease, other cardiac problems and incidental findings will follow as per the SCOT-HEART-2 protocol. Patients will be made aware that the presented findings are a focused preliminary report and that a more detailed formal report will follow.
干预措施: Delivery of CT scan results (Other)
结局指标
主要结局
Proportion of patients who meet National Institute for Heath and Care Excellence (NICE) recommendations on risk factor modifications
时间窗: 6 months
The primary endpoint will be the proportion of patients who meet NICE recommendations on diet, smoking, weight and activity levels (%)
次要结局
- Quality of life/Anxiety and Depression(6 months)
- ASSIGN score(6 months)
- 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)