Effect of visual presentation of atherosclerotic carotid plaque on adherence to secondary preventive therapy using mHealth technologies (PreventiPlaque app): Study protocol for a randomized controlled trial

BACKGROUND: Cardiovascular disease is the major cause of death worldwide. Although knowledge regarding diagnosing and treating cardiovascular disease has increased dramatically, secondary prevention remains insufficiently implemented due to failure among affected individuals to adhere to guideline recommendations. This has continued to lead to high morbidity and mortality rates. Involving patients in their healthcare and facilitating their active roles in their chronic disease management is an opportunity to meet the needs of the increasing number of cardiovascular patients. However, simple recall of advice regarding a more preventive lifestyle does not affect sustainable behavioral lifestyle changes. We investigate the effect of plaque visualization combined with low-threshold daily lifestyle tasks using the smartphone app PreventiPlaque to evaluate change in cardiovascular risk profile. METHODS: and study design: This randomized, controlled clinical trial includes 240 participants with ultrasound evidence of atherosclerotic plaque in one or both carotid arteries, defined as focal thickening of the vessel wall measuring 50% more than the regular vessel wall. A criterion for participation is access to a smartphone suitable for app usage. The participants are randomly assigned to an intervention or a control group. While both groups receive the standard of care, the intervention group has additional access to the PreventiPlaque app during the 12-month follow-up. The app includes daily tasks that promote a healthier lifestyle in the areas of smoking cessation, medication adherence, physical activity, and diet. The impact of plaque visualization and app use on the change in cardiovascular risk profile is assessed by SCORE2. Feasibility and effectiveness of the PreventiPlaque app are evaluated using standardized and validated measures for patient feedback. ETHICS AND DISSEMINATION: This clinical trial is approved by the ethics committee of the University of Duisburg-Essen (Germany). Study results will be disseminated at conferences and in peer-reviewed journals. Information regarding the PreventiPlaque app is available via print media, social media channels, and on the authors’ websites.