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Published on: April 19, 2019
Individualized mobile health interventions for cardiovascular event prevention in patients with coronary heart
Yuling Chen1,2,3, Meihua Ji1,4, Ying Wu5
1School of Nursing, Capital Medical University, 10 You-an-men Wai Xi-tou-tiao, Feng-Tai District, Beijing, 100069, China.
Insights
Mobile health interventions using the iCARE system may reduce cardiovascular events in coronary heart disease patients. This study investigates the effectiveness of individualized mHealth interventions for cardiovascular risk management.
Area of Science:
- Cardiology
- Digital Health
- Preventive Medicine
Background:
- Mobile health (mHealth) interventions show promise for managing cardiovascular risk factors.
- Individualized interventions are key for effective cardiovascular disease management.
Purpose of the Study:
- To assess the efficacy of the Individualized Cardiovascular Application system for Risk Elimination (iCARE) in reducing major cardiovascular events.
- To evaluate the impact of mHealth-based individualized interventions on secondary prevention in coronary heart disease (CHD) patients.
Main Methods:
- A large-scale, multi-center, randomized controlled trial involving 2820 CHD patients.
- Participants were randomized into three groups: iCARE with rich media, iCARE with text only, and standard care.
- Follow-up occurred at 1, 3, 6, 12, 24, and 36 months, with the primary outcome being major cardiovascular events within 3 years.
Main Results:
- Primary outcome: incidence of major cardiovascular events within 3 years.
- Secondary outcomes: changes in health behaviors, medication adherence, and cardiovascular health score.
Conclusions:
- The iCARE trial will provide empirical evidence for mHealth-based secondary preventive care in CHD patients.
- Results will guide future research in intelligent, individualized cardiovascular risk management.
Background:
Mobile health-based individualized interventions have shown potential effects in managing cardiovascular risk factors. This study aims to assess whether or not mHealth based individualized interventions delivered by an Individualized Cardiovascular Application system for Risk Elimination (iCARE) could reduce the incidence of major cardiovascular events in individuals with coronary heart disease.
Methods:
This study is a large-scale, multi-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted from September 2019 to December 2025. A total of 2820 patients with coronary heart disease will be recruited from two clinical sites and equally randomized into three groups: the intervention group and two control groups. All participants will be informed of six-time points (at 1, 3, 6, 12, 24, and 36 months after discharge) for follow-up visits. Over a course of 36 months, patients who are randomized to the intervention arm will receive individualized interventions delivered by a fully functional iCARE that using various visualization methods such as comics, videos, pictures, text to provide individualized interventions in addition to standard care. Patients randomized to control group 1 will receive interventions delivered by a modified iCARE that only presented in text in addition to routine care. Control group 2 will only receive routine care. The primary outcome is the incidence of major cardiovascular events within 3 years of discharge. Main secondary outcomes include changes in health behaviors, medication adherence, and cardiovascular health score.
Discussion:
If the iCARE trial indeed demonstrates positive effects on patients with coronary heart disease, it will provide empirical evidence for supporting secondary preventive care in this population. Results will inform the design of future research focused on mHealth-based, theory-driven, intelligent, and individualized interventions for cardiovascular risk management.
Trial Registration:
Trial registered 24th December 2016 with the Chinese Clinical Trial Registry (ChiCTR-INR-16010242). URL: http://www.chictr.org.cn/showproj.aspx?proj=17398 .
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