Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention
Condition: Cardiovascular Disease; Stroke; Primary Prevention
MeSH terms: Stroke; Cardiovascular Diseases
Study type: Interventional

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
    

Intervention name(s): The strategic use of messages in risk communication
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention