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

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ClinicalTrials.gov Identifier: NCT04450888
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Centers for Disease Control and Prevention, China
Beijing Tiantan Hospital
First Affiliated Hospital of Chongqing Medical University
China Stroke Databank Center
Information provided by (Responsible Party):
Li He, West China Hospital

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Stroke Primary Prevention Other: The strategic use of messages in risk communication Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : January 21, 2022
Estimated Study Completion Date : January 21, 2022

Arm Intervention/treatment
Model A
Total cardiovascular disease (CVD)-free life expectancy gain in one's remaining life.
Other: 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.

Model B
Average CVD-free life expectancy gain per year.
Other: 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.

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

Model D
Average CVD-free life expectancy loss that can be reclaimed per year.
Other: 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.




Primary Outcome Measures :
  1. 10-year CVD risk [ Time Frame: At the 1-year follow-up ]
  2. Lifetime CVD risk [ Time Frame: At the 1-year follow-up ]
  3. CVD-free life expectancy [ Time Frame: At the 1-year follow-up ]

Secondary Outcome Measures :
  1. Changes in systolic and diastolic blood pressure [ Time Frame: At the 1-year follow-up ]
  2. Changes in serum cholesterol level [ Time Frame: At the 1-year follow-up ]
  3. Changes in serum LDL level [ Time Frame: At the 1-year follow-up ]
  4. Changes in serum non-HDL level [ Time Frame: At the 1-year follow-up ]
  5. Changes in serum triglycerides level [ Time Frame: At the 1-year follow-up ]
  6. Changes in fasting glucose level [ Time Frame: At the 1-year follow-up ]
  7. 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 ]
  8. Changes in tobacco use [ Time Frame: At the 1-year follow-up ]
    Tobacco use status (current, former, never) in the records at visits

  9. Changes in alcohol use (AUDIT questionnaire) [ Time Frame: At the 1-year follow-up ]
  10. Changes in dietary habits (food frequency questionnaire) [ Time Frame: At the 1-year follow-up ]
  11. 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.

  12. Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user) [ Time Frame: At the 1-year follow-up ]
  13. Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user) [ Time Frame: At the 1-year follow-up ]
  14. Changes adherence to anti-thrombotic therapy (proportion of persistent medication user) [ Time Frame: At the 1-year follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450888


Contacts
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Contact: Muke Zhou, M.D. +86 18980601686 zmkemail@126.com
Contact: Jian Guo, M.D. +86 18980606718 water-deep1983@163.com

Sponsors and Collaborators
West China Hospital
Centers for Disease Control and Prevention, China
Beijing Tiantan Hospital
First Affiliated Hospital of Chongqing Medical University
China Stroke Databank Center
Investigators
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Principal Investigator: Li He, M.D. West China Hospital
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Responsible Party: Li He, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT04450888    
Other Study ID Numbers: 610041
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases