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Cardiovascular DiseaseEMT-OCSPNCT04450888

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

A study testing The strategic use of messages in risk communication in people with Cardiovascular Disease and Stroke, run by West China Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Cardiovascular Disease, Stroke, Primary Prevention
What is being tested?
The strategic use of messages in risk communication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13,114 participants
Where
1 siteChina
Study dates
1 Jul 2020to 22 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Health center of Sipo town

    Yibin, Sichuan

Other trials in China

About this study

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

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.

Read the 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

Being tested
The strategic use of messages in risk communication
Medical subject headings
Cardiovascular Diseases, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The strategic use of messages in risk communicationOther

    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 groups in NCT04450888
Study groupRoleWhat they receive
Model AOtherTotal cardiovascular disease (CVD)-free life expectancy gain in one's remaining life.
Receives: Other: The strategic use of messages in risk communication
Model BOtherAverage CVD-free life expectancy gain per year.
Receives: Other: The strategic use of messages in risk communication
Model COtherTotal CVD-free life expectancy loss that can be reclaimed in one's remaining life.
Receives: Other: The strategic use of messages in risk communication
Model DOtherAverage CVD-free life expectancy loss that can be reclaimed per year.
Receives: Other: The strategic use of messages in risk communication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 10-year CVD risk

    Measured: At the 1-year follow-up

  2. Lifetime CVD risk

    Measured: At the 1-year follow-up

  3. CVD-free life expectancy

    Measured: At the 1-year follow-up

Secondary outcomes (14)

  1. Changes in systolic and diastolic blood pressure

    Measured: At the 1-year follow-up

  2. Changes in serum cholesterol level

    Measured: At the 1-year follow-up

  3. Changes in serum LDL level

    Measured: At the 1-year follow-up

  4. Changes in serum non-HDL level

    Measured: At the 1-year follow-up

  5. Changes in serum triglycerides level

    Measured: At the 1-year follow-up

  6. Changes in fasting glucose level

    Measured: 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)

    Measured: At the 1-year follow-up

  8. Changes in tobacco use

    Tobacco use status (current, former, never) in the records at visits

    Measured: At the 1-year follow-up

  9. Changes in alcohol use (AUDIT questionnaire)

    Measured: At the 1-year follow-up

  10. Changes in dietary habits (food frequency questionnaire)

    Measured: At the 1-year follow-up

  11. Changes adherence to pharmacological treatments for hypertension (proportion of persistent medication user）

    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.

    Measured: At the 1-year follow-up

  12. Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user）

    Measured: At the 1-year follow-up

  13. Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user）

    Measured: At the 1-year follow-up

  14. Changes adherence to anti-thrombotic therapy (proportion of persistent medication user）

    Measured: At the 1-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start1 Jul 2020
  3. Primary completion22 Jan 2022
  4. Study completion22 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
13,114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04450888
Sponsor's protocol ID
610041
Acronym
EMT-OCSP
Status last verified
Mar 2022
First submitted
11 Jun 2020
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 33762233

Questions about this trial

What is this clinical trial studying?

A study testing The strategic use of messages in risk communication in people with Cardiovascular Disease and Stroke, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

10-year CVD risk (time frame: At the 1-year follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04450888, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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