Clinical trial NCT02615704: "Me and My Heart" Study
Official title: Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Brilique treatment adherence via electronic device application (APP)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 677
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of tablets taken during the observation phase
timeFrame: An average of 48 weeks
Secondary outcomes:
measure: Percentage of tablets taken during the observation phase
timeFrame: An average of 48 weeks
measure: The percent change in key risk factors
timeFrame: 1 year
measure: Change in Quality of Life
timeFrame: 1 year
measure: Change in patient reported lifestyle changes
timeFrame: An average of one year
measure: Disease understanding and treatment awareness
timeFrame: Every four weeks during 48 weeks observational phase
measure: Health care utilization
timeFrame: Every four weeks during the 48 weeks observational phase
Other outcomes:
measure: Cardiovascular risk score GRACE 2.0
timeFrame: During baseline
measure: Treatment gaps according to missed tablets obtained in the subgroup of patients equipped
timeFrame: During 48 weeks observational phase
measure: Patients' report on the use of alternative medication reminder or other health APPs
timeFrame: An average of one year
measure: For the active treatment group, data on the use of the patient support tool
timeFrame: An average of one year
measure: For the active treatment group, responses to the questions of the System Usability Scale (SUS)
timeFrame: An average of one year
Locations:
city: Bad Berka
country: Germany
facility: Research Site
city: Bad Bevensen
country: Germany
facility: Research Site
city: Bad Krozingen
country: Germany
facility: Research Site
city: Barby
country: Germany
facility: Research Site
city: Berlin-Tegel
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bernau
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Coburg
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Erkrath
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Gelsenkirchen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kassel
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Kleve
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Mönchengladbach
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Rotenburg
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Wuppertal
country: Germany
facility: Research Site
Study officials:
affiliation: Charite University, Berlin, Germany
name: Florian Krackhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krackhardt F, Jornten-Karlsson M, Waliszewski M, Knutsson M, Niklasson A, Appel KF, Degenhardt R, Ghanem A, Kohler T, Ohlow MA, Tschope C, Theres H, Vom Dahl J, Karlson BW, Maier LS. Results from the "Me & My Heart" (eMocial) Study: a Randomized Evaluation of a New Smartphone-Based Support Tool to Increase Therapy Adherence of Patients with Acute Coronary Syndrome. Cardiovasc Drugs Ther. 2023 Aug;37(4):729-741. doi: 10.1007/s10557-022-07331-1. Epub 2022 Apr 20.
citation: Krackhardt F, Maier LS, Appel KF, Kohler T, Ghanem A, Tschoepe C, Dahl JV, Degenhardt R, Niklasson A, Ahlqvist M, Waliszewski MW, Jornten-Karlsson M. Design and rationale for the "Me & My Heart" (eMocial) study: A randomized evaluation of a new smartphone-based support tool to increase therapy adherence of patients with acute coronary syndrome. Clin Cardiol. 2019 Nov;42(11):1054-1062. doi: 10.1002/clc.23254. Epub 2019 Sep 6.