Background
Digital health interventions present an opportunity to support chronically ill patients in their disease management. With cardiovascular disease still being the major cause of premature deaths worldwide, the need for support in this collective remains high. Secondary prevention is a cornerstone in the treatment of chronic atherosclerotic cardiovascular disease but adherence to the necessary lifestyle modifications is still rather low. mHealth technologies present a tool to improve long-term adherence to these lifestyle changes. In this regard, a high level of personalization seems to increase patients’ engagement, leading to better results.
Objective
The aim of this trial was to evaluate the impact of visualization of atherosclerotic carotid plaque in combination with daily tasks, prompting positive lifestyle modification, on the overall cardiovascular risk profile of patients with atherosclerotic cardiac disease. Plaque visualization as well as daily tasks were conveyed using an mHealth technology, the PreventiPlaque app.
Methods
This two-armed randomized, controlled, single-center, clinical trial included 240 participants with coronary arterial disease and ultrasound evidence of atherosclerotic plaque in one or both carotid arteries. The intervention group received access to the PreventiPlaque app during the twelve-month study period, while both groups received the same standard of care. Within the app, participants were encouraged to fulfill daily tasks that promoted healthy lifestyle modifications. Moreover, the PreventiPlaque app included ultrasound images of the participants individual carotid plaque, which were updated within the intervention period. The impact of plaque visualization in combination with app usage was evaluated, using a change in the overall cardiovascular risk profile, measured by the SCORE2, as the primary endpoint. As secondary endpoints, cardiovascular risk factors such as LDL-C levels, HbA1c and systolic blood pressure were evaluated and physical activity, medication adherence and quality of life were assessed.
Results
In the intervention group, the primary outcome SCORE2 was significantly lower twelve months after the baseline examination (t(120) = 6.43, padj < .001, dRM = .58). The PreventiPlaque app also significantly impacted several secondary outcomes: LDL-C levels (t(120) = 6.27, padj < .001, dRM = .51), systolic blood pressure (t(120) = 7.20, padj < .001, dRM = .56), medication adherence (t(120) = 4.19, padj < .001, dRM = .32), and quality of life (t(120) = 3.64, padj = .004, dRM = .32). HbA1c and physical activity were not affected by the intervention (padj > .05).
Conclusions
This trial demonstrates the efficacy of the PreventiPlaque app in supporting lifestyle modifications for patients with atherosclerotic cardiovascular disease. The intervention significantly reduced the overall cardiovascular risk (SCORE2) and improved several key risk factors, including LDL-C levels, systolic blood pressure, medication adherence, and quality of life. These findings suggest that personalized mHealth interventions can be valuable tools in the secondary prevention of chronic atherosclerotic cardiovascular disease, enhancing long-term patient outcomes
