Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04450888 |
Other study ID # |
610041 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2020 |
Est. completion date |
January 22, 2022 |
Study information
Verified date |
March 2022 |
Source |
West China Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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