- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04450888
Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention (EMT-OCSP)
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sichuan
-
Yibin, Sichuan, China
- Health center of Sipo town
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Model A
Total cardiovascular disease (CVD)-free life expectancy gain in one's remaining life.
|
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.
|
OTHER: Model B
Average CVD-free life expectancy gain per year.
|
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.
|
OTHER: Model C
Total CVD-free life expectancy loss that can be reclaimed in one's remaining life.
|
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.
|
OTHER: Model D
Average CVD-free life expectancy loss that can be reclaimed per year.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
10-year CVD risk
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
Lifetime CVD risk
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
CVD-free life expectancy
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in systolic and diastolic blood pressure
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in serum cholesterol level
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in serum LDL level
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in serum non-HDL level
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in serum triglycerides level
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in fasting glucose level
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in physical activity (International Physical Activity Questionnaire or International Physical Activity Questionnaire Short Version Modified for Elderly)
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in tobacco use
Time Frame: At the 1-year follow-up
|
Tobacco use status (current, former, never) in the records at visits
|
At the 1-year follow-up
|
Changes in alcohol use (AUDIT questionnaire)
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes in dietary habits (food frequency questionnaire)
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes adherence to pharmacological treatments for hypertension (proportion of persistent medication user)
Time Frame: 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.
|
At the 1-year follow-up
|
Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user)
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user)
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
|
Changes adherence to anti-thrombotic therapy (proportion of persistent medication user)
Time Frame: At the 1-year follow-up
|
At the 1-year follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Li He, M.D., West China Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 610041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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