Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention(EMT-OCSP): a Pragmatic,Multi-centre, Observer-blinded,12-month Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,114
- 试验地点
- 1
- 主要终点
- Lifetime CVD risk
研究概览
简要总结
Effects of Message framing and Time discounting on heath communication for Optimum Cardiovascular disease and Stroke Prevention（EMT-OCSP）is a pragmatic, 2 × 2 factorial, randomized, controlled, observer blinded, multicenter trial with four parallel groups. It aims to determine if risk and intervention communication strategy（gain-framed versus loss-frame, long-term context versus short-term context and the potential interaction）have different effect on optimizing adherence to clinical preventive management （in the endpoint of CVD risk reduction）for subjects with at least one moldable risk factor for CVD.
详细描述
Scientific title Effects of Message framing and Time discounting on health communication for Optimum Cardiovascular disease and Stroke Prevention(EMT-OCSP): a pragmatic randomised controlled study
Principal Investigator Li He
Study period 2020-07-01-2022-01-21
Hypotheses and aims When communicating cardiovascular disease（CVD）risk to individuals, different presentation of information carries its own connotations and biases. The one or the other pattern of the presentation may affect individuals' decision making.This study aims to determine if risk and intervention communication strategy（gain-framed versus loss-frame, long-term context versus short-term context and the potential interaction）have different effect on optimizing adherence to clinical preventive management （in the endpoint of CVD risk reduction）for subjects with at least one moldable risk factor for CVD. We aim to provide evidence for practitioners regarding messaging strategies that improve communication effectiveness and further reduce the risk of CVD events in the population, as well as to develop more effective communication strategies for groups of people with different characteristics to maximise patient adherence to lifestyle modifications and medical treatment.
Primary outcome Ten-year CVD risk, lifetime CVD risk and CVD-free life expectancy after 1 year according to the LIFE-CVD model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 45-80 years,
- •personally own and use a smartphone (Apple or Android platform) with Internet access,
- •and have at least one of the following CVD risk factors: history of CVD at age < 60 years in a first-degree relative, smoking, diabetes, hypertension, and low-density lipoprotein (LDL)cholesterol ≥ 4.5 mmol/L.
排除标准
- •participants with histories of CVD, heart failure, or chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73m2);
- •those with terminal malignancy at baseline;
- •those with severe psychological or mental disorders
- •violation of the study protocol and participation in another clinical study during follow-up
结局指标
主要结局
Lifetime CVD risk
时间窗: At the 1-year follow-up
10-year CVD risk
时间窗: At the 1-year follow-up
CVD-free life expectancy
时间窗: At the 1-year follow-up
次要结局
- Changes in serum non-HDL level(At the 1-year follow-up)
- Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user）(At the 1-year follow-up)
- Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user）(At the 1-year follow-up)
- Changes in serum cholesterol level(At the 1-year follow-up)
- Changes in dietary habits (food frequency questionnaire)(At the 1-year follow-up)
- Changes in systolic and diastolic blood pressure(At the 1-year follow-up)
- Changes in serum LDL level(At the 1-year follow-up)
- Changes in serum triglycerides level(At the 1-year follow-up)
- Changes in fasting glucose level(At the 1-year follow-up)
- Changes in physical activity (International Physical Activity Questionnaire or International Physical Activity Questionnaire Short Version Modified for Elderly)(At the 1-year follow-up)
- Changes in tobacco use(At the 1-year follow-up)
- Changes in alcohol use (AUDIT questionnaire)(At the 1-year follow-up)
- Changes adherence to pharmacological treatments for hypertension (proportion of persistent medication user）(At the 1-year follow-up)
- Changes adherence to anti-thrombotic therapy (proportion of persistent medication user）(At the 1-year follow-up)