Primary and secondary prevention of cardiovascular disease by digital lifestyle management

Background:

Lifestyle changes can reduce cardiovascular morbidity and mortality, but many prevention programs require large healthcare resources and fail to provide continuous support. Data from SWEDEHEART show e.g. that only a minority of patients attend exercise training or change dietary habits after their first myocardial infarction. To potentially alleviate this problem, we have developed a new method for continuous lifestyle management, provided as a digital tool.

In patients with diabetes and increased cardiovascular risk, usage of the tool resulted in sustained and clinically significant improvements of blood pressure, blood glucose and body weight over a total follow-up of 730 days. Objectives:

In light of this, we will test the hypothesis that continuous digital lifestyle support can reduce the incidence of major adverse cardiovascular events (MACE), the composite of cardiovascular death, myocardial infarction, stroke, or hospitalization for heart failure. We will also evaluate the cost-effectiveness of the intervention.

Work plan:

The programme will involve 90,000 individuals from the general population. The intervention will also be integrated in national cardiac rehabilitation programs involving 15,000 patients after myocardial infarction.

All study participants will be randomly assigned to access the intervention tool for three years or to a control group without access. We will obtain baseline and yearly follow-up data on the incidence of MACE and prescribed drugs in the randomized arms. Intraindividual changes in quality of life, physical activity, anxiety and depressive symptoms will be assessed as secondary endpoints.

Furthermore, changes in physiological, psychosocial and lifestyle variables and cardiac symptoms will be analysed from participants in cardiac rehabilitation via SWEDEHEART. These data will finally be used to estimate the health economic consequences of the intervention. Significance:

This research programme represents a nation-wide effort to investigate the primary and secondary preventive effects of a new method for digital lifestyle management. The intervention tool adds a new approach to lifestyle treatment, and the study could potentially address the large unmet need for scalable lifestyle support to prevent cardiovascular disease at low cost with sustained efficacy.

The design of the study will facilitate integration of the intervention into clinical care, and the results could have an immediate clinical impact.