Me and My Heart Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: Active group with MEMS
* Device: Active group without MEMS
* Device: Control group with MEMS
* Device: Control group without MEMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated patient informed consent prior to randomisation Female or male aged 18 years or older Acute Coronary Syndrome patients, diagnosed with ST elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina pectoris treated with Brilique (ticagrelor) prior to inclusion into this study and for whom the treating physician intends to continue prescribing 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 Ability to read, understand and write German Patients must have access to an electronic device (compatible with the patient support tool) and willing to use it on a daily basis Exclusion Criteria: Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff and/or staff at the study site and application developer) Participation in another clinical study with an investigational product or medical device during the last 30 days, excluding prospective/retrospective register based studies that do not require any extra visits in addition to ordinary health care Patients on treatment with Oral Anti-Platelet drugs other than Brilique (ticagrelor) Patients with contraindication to the use of Brilique (ticagrelor) Patients accepted/with a plan for thoracic surgery (coronary artery bypass grafting, CABG) or any other elective surgery that cannot be postponed until after study participation Presence of serious/severe co-morbidities in the opinion of the Investigator which may limit life expectancy (<1 year) For women only: patients who are currently pregnant (confirmed with positive pregnancy test) or breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active APP with MEMS<br>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<br>* Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool and with MEMS<br>* Other names: Group A with MEMS;|
| Active APP without MEMs<br>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<br>* Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool but without MEMS<br>* Other names: Group A without MEMS;|
| Control APP with MEMS<br>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<br>* Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool but with MEMS<br>* Other names: Group B with MEMS;|
| Control APP without MEMS<br>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<br>* Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool and without MEMS<br>* Other names: Group B without MEMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of tablets taken during the observation phase | Adherence to prescribed treatment according to questions 1-4 in the Brilique Adherence Questionnaire (BAQ) including a scoring system for quantification from 0-14 (i.e. one deduction for every missed Brilique (ticagrelor) tablet per week with 7 days and twice daily dosing). The BAQ will be delivered via the APP every 4 weeks. The percent of tablets taken from the last week asked for in BAQ, will be representing the last 4 weeks of Brilique use. | An average of 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of tablets taken during the observation phase | Tablets taken measured by a Medical Event Monitoring System (MEMS) to record a time stamp for every tablets taken | An average of 48 weeks | 
| The percent change in key risk factors | Key risk factors like blood pressure, laboratory parameters (if available: LDL cholesterol, HDL cholesterol, HbA1c, body weight, and BMI) | 1 year | 
| Change in Quality of Life | Change in Quality of Life assessed by Short Form 36 Questionnaire (SF-36v2) | 1 year | 
| Change in patient reported lifestyle changes | Lifestyle changes assessed by a Lifestyle Changes Questionnaire (LSQ) at V1 and V2 (patient reported outcome (PRO) instrument | An average of one year | 
| Disease understanding and treatment awareness | Assessed according to questions 5-11 in the BAQ | Every four weeks during 48 weeks observational phase | 
| Health care utilization | Assessed on the questions 12-15 in the BAQ | Every four weeks during the 48 weeks observational phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brilique treatment adherence via electronic device application (APP)