Using Smart Technology to Improve Outcomes in Myocardial Infarction Patients: Rationale and Design of a Protocol for a Randomized Controlled Trial, The Box.

BACKGROUND: Recent evidence suggests that frequent monitoring using smartphone-compatible wearable technologies might improve clinical effectiveness and patient satisfaction of care.

OBJECTIVE: The aim of this study is to investigate the clinical effectiveness and patient satisfaction of a smart technology intervention in patients admitted with a ST elevation myocardial infarction (STEMI) or non-ST acute coronary syndrome (NST-ACS).

METHODS: In this single center, open, randomized controlled trial patients who suffered from STEMI or NST-ACS will be randomized 1:1 to an intervention group or control group. Both groups will be followed up to one year after the index event. The intervention group will take daily measurements with a smartphone-compatible electrocardiogram device, blood pressure (BP) monitor, weight scale, and activity tracker. Furthermore, two of four outpatient clinic visits will be replaced by electronic visits (1 and 6 months after index event). The control group will receive regular care, consisting of four outpatient clinic visits (1, 3, 6, and 12 months after index event). All patients will be asked to fill in validated questionnaires about patient satisfaction, quality of life, propensity of medication adherence, and physical activity.

RESULTS: The primary outcome of this trial will be percentage of patients with controlled BP. Secondary outcomes include patient satisfaction, health care utilization, major adverse cardiac events, medication adherence, physical activity, quality of life, and percentage of patients in which a sustained arrhythmia is detected.

CONCLUSIONS: Smart technology could potentially improve care in postmyocardial infarction patients. This trial will investigate whether usage of smart technology can improve clinical- and cost-effectiveness of care.

TRIAL REGISTRATION: Clinicaltrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376 (Archived by WebCite at https://www.webcitation.org/6tcvAdbdH).