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

NCT04450888 | Completed DMC

• 1 other identifier: 610041
• Study Type: interventional
• Target: 13,114
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Stroke; Primary Prevention

Outcome Measures

Primary Outcomes (3)

• 10-year CVD risk

  At the 1-year follow-up

• Lifetime CVD risk

  At the 1-year follow-up

• CVD-free life expectancy

  At the 1-year follow-up

Secondary Outcomes (14)

• Changes in systolic and diastolic blood pressure

  At the 1-year follow-up

• Changes in serum cholesterol level

  At the 1-year follow-up

• Changes in serum LDL level

  At the 1-year follow-up

• Changes in serum non-HDL level

  At the 1-year follow-up

• Changes in serum triglycerides level

  At the 1-year follow-up

Study Arms (4)

Model A

OTHER

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

Other: The strategic use of messages in risk communication

Model B

OTHER

Average CVD-free life expectancy gain per year.

Other: The strategic use of messages in risk communication

Model C

OTHER

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

Other: The strategic use of messages in risk communication

Model D

OTHER

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

Other: The strategic use of messages in risk communication

Interventions

The strategic use of messages in risk communication 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 A; Model B; Model C; Model D

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead
• Centers for Disease Control and Prevention, China: collaborator
• Beijing Tiantan Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• China Stroke Databank Center: collaborator

Study Sites (1)

Health center of Sipo town

Yibin, Sichuan, China

Location

Related Publications (1)

• 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.

  PMID: 33762233 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Li He, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 30, 2020
• Study Start: July 1, 2020
• Primary Completion: January 22, 2022
• Study Completion: January 22, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication

Locations

CN (1)