Cardiovascular Disease, Primary Prevention, Stroke
Conditions
Brief summary
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.
Detailed description
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. Secondary outcomes CVD risk factors \[blood pressure(BP) and serum cholesterol, low-density lipoprotein (LDL), non-high-density lipoprotein (HDL), triglycerides and fasting glucose levels\],lifestyle factors (physical activity, tobacco use, alcohol use and eating habits), pharmacological treatments for hypertension, dyslipidaemia and diabetes, and anti-thrombotic drug prescriptions after 1 year. Study design The EMT-OCSP trial is designed as a pragmatic, 2 × 2 factorial, randomized, controlled, observer blinded, multicenter trial with four parallel groups. Randomization will be performed as block randomization with a 1:1:1:1 allocation. Study population and sample size Subjects with at least one moldable risk factor for CVD. The sample size calculations revealed that the enrolment of 15,000 participants would be sufficient, allowing for a 20% drop-out rate. Follow-up period One year
Interventions
OTHERThe strategic use of messages in risk communication
The interventions in the EMT-OCSP study are strategic health messages delivered (gain-framed vs.loss-framed and long-term vs.short-term contexts) to individuals based on their calculated CVD-free life expectancy and potential interventional benefits.
Sponsors
Centers for Disease Control and Prevention, China
Beijing Tiantan Hospital
First Affiliated Hospital of Chongqing Medical University
China Stroke Databank Center
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10-year CVD risk | At the 1-year follow-up |
| Lifetime CVD risk | At the 1-year follow-up |
| CVD-free life expectancy | At the 1-year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum non-HDL 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 | Tobacco use status (current, former, never) in the records at visits |
| Changes in systolic and diastolic blood pressure | At the 1-year follow-up | — |
| Changes in dietary habits (food frequency 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 | A persistent medication user is defined as a participant who has purchased the drug at least once during each 3-month interval during our study. |
| 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 adherence to anti-thrombotic therapy (proportion of persistent medication user） | At the 1-year follow-up | — |
| Changes in alcohol use (AUDIT questionnaire) | At the 1-year follow-up | — |
| Changes in serum cholesterol level | At the 1-year follow-up | — |
| Changes in serum LDL level | At the 1-year follow-up | — |
Countries
China
Outcome results
None listed