"Me and My Heart" Study
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Observational

Summary: 
      An electronic device application (APP) "Mein Herz und ich" has been developed specifically
      for acute coronary syndrome (ACS) patients who are prescribed to Brilique (ticagrelor) to
      increase adherence to treatment (medication and lifestyle changes) by a combination of
      reminders on medication intake, information on the importance of treatment, motivation by
      supportive messages, and visualisation of individual lifestyle choices' effect on
      cardiovascular risk. The aim of this study is to evaluate the effectiveness of this patient
      support tool
    

Detailed description: 
      The target population are patients hospitalised with acute coronary syndrome (ACS) 18 years
      or older with access to an electronic device (compatible with the patient support tool),
      diagnosed with ST elevation myocardial infarction (STEMI), non-ST elevation myocardial
      infarction (NSTEMI), unstable angina pectoris (UA) and treated with twice daily Brilique
      (ticagrelor) co administered with low dose acetylsalicylic acid (ASA) according to the
      prescription recommendation, within 14 days following the diagnosis of the ACS event.
      Patients will be randomised 1:1 into an active group receiving the patient support tool under
      investigation via electronic device application (APP) and a control group without patient
      support tool. In addition, both active and control group will be randomised 1:1 to a group
      with or without use of a Medical Event Monitoring System (MEMS) for evaluation of treatment
      adherence. Patient questionnaires for evaluation of lifestyle changes, and quality of life
      will be administered at the beginning (Visit 1) and end (Visit 2) of the observation period.
      In addition, questionnaires for adherence, treatment attitudes, health care utilization and
      risk factors will be administered in monthly intervals

      This is a randomised investigation according to paragraph 23b of the German Medical Device
      Law examining the impact of the APP use on drug adherence, drug persistence and lifestyle
      changes in patients who have been prescribed Brilique (ticagrelor) as part of normal clinical
      practice in a 12 month timeframe after their ACS episode.

      The device has a European Conformity Declaration (CE-mark). In this study no investigational
      product will be dispensed to the study participants. Patients will need to provide their own
      Brilique(ticagrelor) supply from the pharmacy, as in common clinical practice. Further,
      assessments in this study will not be used for guiding the treatment of the patients
      participating in the study.
    

Intervention name(s): Active group with MEMS; Active group without MEMS; Control group with MEMS; Control group without MEMS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool and with MEMS; Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool but without MEMS; Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool but with MEMS; Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool and without MEMS
Other intervention name(s): Group A with MEMS; Group A without MEMS; Group B with MEMS; Group B without MEMS
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The target population are acute coronary syndrome (ACS) patients 18 years or older with
        access to an electronic device (compatible with the patient support tool), diagnosed with
        ST elevation myocardial infarction, non-ST elevation myocardial infarction or unstable
        angina pectoris treated with twice daily Brilique (ticagrelor) co administered with low
        dose acetylsalicylic acid according to the prescription recommendation, within 14 days
        following the diagnosis of the ACS event.
      
Keywords: Brilique treatment adherence via electronic device application (APP)