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July 13, 2021BMC Cardiovascular DisordersOpen Access

Individualized mobile health interventions for cardiovascular event prevention in patients with coronary heart disease: study protocol for the iCARE randomized controlled trial

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Why the study?

Does an individualized, visualized mobile health intervention (iCARE) reduce the incidence of major cardiovascular events in patients with coronary heart disease compared to text-only or routine care?

Population

2,820 planned adult patients with a documented diagnosis of coronary heart disease who own and daily use an…

Comparison

Individualized mobile health interventions… vs Two control groups: Control group 1 receives…

Design

RCT, 1:1:1 allocation via computer-generated stratified block randomization…

Follow-up

36 months

Key result

The iCARE trial is an ongoing randomized controlled study designed to assess whether an individualized mobile health intervention reduces the incidence of major cardiovascular events in patients with coronary heart disease.

Authors

YCYuling ChenMJMeihua JiYWYing Wu

Discussion

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Overview

This study protocol outlines a large-scale randomized controlled trial to evaluate whether a visualized, individualized mobile health intervention can reduce major cardiovascular events in patients with coronary heart disease.

Study Design

Type

RCT (n=2,820)

Blinding

Open-label

Randomization

Stratified block randomization

Multicenter

Yes

Structured PICO

Does an individualized, visualized mobile health intervention (iCARE) reduce the incidence of major cardiovascular events in patients with coronary heart disease compared to text-only or routine care?

P
Population
2,820 planned adult patients (≥18 years) with a documented diagnosis of coronary heart disease (acute myocardial infarction, acute coronary syndrome, or undergoing percutaneous coronary intervention) who own and daily use an Android smartphone.
I
Intervention
Individualized mobile health interventions delivered via the iCARE-1 app (using visual formats like comics, videos, pictures, and text) plus routine care over 36 months.
C
Comparator
Two control groups: Control group 1 receives interventions delivered by a modified iCARE-2 app (text-only format) plus routine care. Control group 2 receives routine care only (with iCARE-3 app installed solely for data collection).
O
Outcome
Incidence of major cardiovascular events (composite of AMI/ACS/stable angina, coronary revascularization, stroke, hospitalized heart failure, or death attributable to any cardiovascular disease) within 3 years of discharge.composite

This study protocol outlines a large-scale randomized controlled trial to evaluate whether a visualized, individualized mobile health intervention can reduce major cardiovascular events in patients with coronary heart disease.

Limitations

  • Open-label design where participants and investigators are aware of group assignment
  • Potential for contamination due to communication among patients discharged from the same hospital units

Cite This Study

Chen et al. (2021) conducted an RCT in Coronary heart disease (n=2,820). iCARE system (Individualized Cardiovascular Application system for Risk Elimination) vs. Modified iCARE (text only) plus routine care, or routine care alone was evaluated on Incidence of major cardiovascular events (MACEs). The iCARE trial is an ongoing randomized controlled study designed to assess whether an individualized mobile health intervention reduces the incidence of major cardiovascular events in patients with coronary heart disease.

synapsesocial.com/papers/6a1d74c95b7fddc3520550bfhttps://doi.org/10.1186/s12872-021-02153-9
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