Study identifier:D5130C00161
ClinicalTrials.gov identifier:NCT02615704
EudraCT identifier:N/A
CTIS identifier:N/A
Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)
Acute Coronary Syndrome
N/A
No
-
All
677
Observational
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: -
Masking: Open Label
Primary Purpose: -
Verified 01 May 2020 by AstraZeneca
AstraZeneca
-
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
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.
Location
Location
Heidelberg, Germany, 69120
Location
Berlin, Germany, D-13353
Location
Rostock, Germany, 18057
Location
Bad Bevensen, Germany, 29549
Location
Wuppertal, Germany, 42117
Location
Lübeck, Germany, 23560
Location
Bad Berka, Germany, 99437
Location
Kassel, Germany, 34121
Arms | Assigned Interventions |
---|---|
Active APP with MEMS ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using active APP with MEMS | Device: Active group with MEMS Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool and with MEMS Other Name: Group A with MEMS |
Active APP without MEMs ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using active APP without MEMS | Device: Active group without MEMS Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool but without MEMS Other Name: Group A without MEMS |
Control APP with MEMS ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using control APP with MEMS | Device: Control group with MEMS Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool but with MEMS Other Name: Group B with MEMS |
Control APP without MEMS ACS patients 18 years or older with access to an electronic device (compatible with the patient support tool), diagnosed with STEMI, NSTEMI or UA treated with twice daily Brilique(ticagrelor) co administered with low dose acetylsalicylic acid according to the prescription recommendation using control APP without MEMS | Device: Control group without 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 Name: Group B without MEMS |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.