Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention (EMT-OCSP)

March 9, 2022 updated by: Li He, West China Hospital

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

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.

Study Overview

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

Interventional

Enrollment (Actual)

13114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sichuan
      • Yibin, Sichuan, China
        • Health center of Sipo town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2020

Primary Completion (ACTUAL)

January 22, 2022

Study Completion (ACTUAL)

January 22, 2022

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (ACTUAL)

June 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers affiliated with the EMT-OCSP study will have access to an internal webpage listing available aggregated datasets and variables; they will not have access to individual data or the original database.External researchers collaborating with at least one steering group member may submit standardised applications for data via this webpage.Upon steering group approval, the data manager will export anonymised aggregated data to authorised researchers.

IPD Sharing Time Frame

6 months after publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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