Clinical trial NCT04450888: Effects of Message Framing and Time Discounting on Health Communication for Optimum Cardiovascular Disease and Stroke 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Stroke
Primary Prevention
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
name: Beijing Tiantan Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: China Stroke Databank Center
First posted: 2020-06-30
Enrollment: 13114
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: 10-year CVD risk
timeFrame: At the 1-year follow-up
measure: Lifetime CVD risk
timeFrame: At the 1-year follow-up
measure: CVD-free life expectancy
timeFrame: At the 1-year follow-up
Secondary outcomes:
measure: Changes in systolic and diastolic blood pressure
timeFrame: At the 1-year follow-up
measure: Changes in serum cholesterol level
timeFrame: At the 1-year follow-up
measure: Changes in serum LDL level
timeFrame: At the 1-year follow-up
measure: Changes in serum non-HDL level
timeFrame: At the 1-year follow-up
measure: Changes in serum triglycerides level
timeFrame: At the 1-year follow-up
measure: Changes in fasting glucose level
timeFrame: At the 1-year follow-up
measure: Changes in physical activity (International Physical Activity Questionnaire or International Physical Activity Questionnaire Short Version Modified for Elderly)
timeFrame: At the 1-year follow-up
measure: Changes in tobacco use
timeFrame: At the 1-year follow-up
measure: Changes in alcohol use (AUDIT questionnaire)
timeFrame: At the 1-year follow-up
measure: Changes in dietary habits (food frequency questionnaire)
timeFrame: At the 1-year follow-up
measure: Changes adherence to pharmacological treatments for hypertension (proportion of persistent medication user）
timeFrame: At the 1-year follow-up
measure: Changes adherence to pharmacological treatments for dyslipidaemia (proportion of persistent medication user）
timeFrame: At the 1-year follow-up
measure: Changes adherence to pharmacological treatments for diabetes (proportion of persistent medication user）
timeFrame: At the 1-year follow-up
measure: Changes adherence to anti-thrombotic therapy (proportion of persistent medication user）
timeFrame: At the 1-year follow-up
Other outcomes:
Locations:
city: Yibin
country: China
facility: Health center of Sipo town
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Li He, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.