Ignite Creation Date:
2024-05-06 @ 7:53 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02615704
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2015-11-11
Brief Title:
Me and My Heart Study
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Evaluation of an Electronic Device Based Support Tool for ACS Patients Brilique Ticagrelor Treatment Adherence eMocial
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eMocial
Brief 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 11 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 11 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 Briliqueticagrelor 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
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 Briliqueticagrelor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None