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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

Tracking Information
First Submitted Date  ICMJE June 11, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date June 30, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • 10-year CVD risk [ Time Frame: At the 1-year follow-up ]
  • Lifetime CVD risk [ Time Frame: At the 1-year follow-up ]
  • CVD-free life expectancy [ Time Frame: At the 1-year follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
  • Changes in systolic and diastolic blood pressure [ Time Frame: At the 1-year follow-up ]
  • Changes in serum cholesterol level [ Time Frame: At the 1-year follow-up ]
  • Changes in serum LDL level [ Time Frame: At the 1-year follow-up ]
  • Changes in serum non-HDL level [ Time Frame: At the 1-year follow-up ]
  • Changes in serum triglycerides level [ Time Frame: At the 1-year follow-up ]
  • Changes in fasting glucose level [ Time Frame: 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 ]
  • Changes in tobacco use [ Time Frame: At the 1-year follow-up ]
    Tobacco use status (current, former, never) in the records at visits
  • Changes in alcohol use (AUDIT questionnaire) [ Time Frame: At the 1-year follow-up ]
  • Changes in dietary habits (food frequency questionnaire) [ Time Frame: 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.
  • Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user) [ Time Frame: 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 ]
  • Changes adherence to anti-thrombotic therapy (proportion of persistent medication user) [ Time Frame: At the 1-year follow-up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke Prevention
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Disease
  • Stroke
  • Primary Prevention
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Model A
    Total cardiovascular disease (CVD)-free life expectancy gain in one's remaining life.
    Intervention: Other: The strategic use of messages in risk communication
  • Model B
    Average CVD-free life expectancy gain per year.
    Intervention: Other: The strategic use of messages in risk communication
  • Model C
    Total CVD-free life expectancy loss that can be reclaimed in one's remaining life.
    Intervention: Other: The strategic use of messages in risk communication
  • Model D
    Average CVD-free life expectancy loss that can be reclaimed per year.
    Intervention: Other: The strategic use of messages in risk communication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2020)
15000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 21, 2022
Estimated Primary Completion Date January 21, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Muke Zhou, M.D. +86 18980601686 zmkemail@126.com
Contact: Jian Guo, M.D. +86 18980606718 water-deep1983@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04450888
Other Study ID Numbers  ICMJE 610041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Li He, West China Hospital
Study Sponsor  ICMJE West China Hospital
Collaborators  ICMJE
  • Centers for Disease Control and Prevention, China
  • Beijing Tiantan Hospital
  • First Affiliated Hospital of Chongqing Medical University
  • China Stroke Databank Center
Investigators  ICMJE
Principal Investigator: Li He, M.D. West China Hospital
PRS Account West China Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP