Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention

NCT ID: NCT04450888

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-01-22

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

Conditions

Cardiovascular Disease; Stroke; Primary Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Model A

Total cardiovascular disease (CVD)-free life expectancy gain in one's remaining life.

Group Type: OTHER

The strategic use of messages in risk communication

Intervention Type: OTHER

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.

Model B

Average CVD-free life expectancy gain per year.

Group Type: OTHER

The strategic use of messages in risk communication

Intervention Type: OTHER

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.

Model C

Total CVD-free life expectancy loss that can be reclaimed in one's remaining life.

Group Type: OTHER

The strategic use of messages in risk communication

Intervention Type: OTHER

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.

Model D

Average CVD-free life expectancy loss that can be reclaimed per year.

Group Type: OTHER

The strategic use of messages in risk communication

Intervention Type: OTHER

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.

Interventions

The 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention, China

OTHER_GOV

Sponsor Role: collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

China Stroke Databank Center

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li He, M.D.

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Health center of Sipo town

Yibin, Sichuan, China

Countries

China

References

Zhou M, Guo J, Chen N, Ma M, Dong S, Li Y, Fang J, Zhang Y, Zhang Y, Bao J, Hong Y, Lu Y, Qin M, Yin L, Yang X, He Q, Ding X, Chen L, Wang Z, Mi S, Chen S, Zhu C, Zhou D, He L. Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention (EMT-OCSP): a protocol for a pragmatic, multicentre, observer-blinded, 12-month randomised controlled study. BMJ Open. 2021 Mar 24;11(3):e043450. doi: 10.1136/bmjopen-2020-043450.

Reference Type: DERIVED

PMID: 33762233 (View on PubMed)

Other Identifiers

610041

Identifier Type: -

Identifier Source: org_study_id