"Me and My Heart" Study
eMocial
Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)
1 other identifier
observational
677
1 country
31
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Typical duration for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedStudy Start
First participant enrolled
February 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2019
CompletedJune 4, 2020
May 1, 2020
3.1 years
November 11, 2015
June 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Percentage of tablets taken during the observation phase
An average of 48 weeks
The percent change in key risk factors
1 year
Change in Quality of Life
1 year
Change in patient reported lifestyle changes
An average of one year
Disease understanding and treatment awareness
Every four weeks during 48 weeks observational phase
- +1 more secondary outcomes
Other Outcomes (5)
Cardiovascular risk score GRACE 2.0
During baseline
Treatment gaps according to missed tablets obtained in the subgroup of patients equipped
During 48 weeks observational phase
Patients' report on the use of alternative medication reminder or other health APPs
An average of one year
- +2 more other outcomes
Study Arms (4)
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
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
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
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
Interventions
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
Eligibility Criteria
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.
You may qualify if:
- Provision of signed and dated patient informed consent prior to randomisation
- Female or male aged 18 years or older
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Bad Berka, 99437, Germany
Research Site
Bad Bevensen, 29549, Germany
Research Site
Bad Krozingen, 79189, Germany
Research Site
Barby, 39249, Germany
Research Site
Berlin, 12203, Germany
Research Site
Berlin, D-13353, Germany
Research Site
Bernau, 16321, Germany
Research Site
Chemnitz, 09116, Germany
Research Site
Coburg, 96450, Germany
Research Site
Düsseldorf, 40217, Germany
Research Site
Erkrath, 40699, Germany
Research Site
Essen, 45219, Germany
Research Site
Frankfurt, 65929, Germany
Research Site
Gelsenkirchen, 45891, Germany
Research Site
Hamburg, 20099, Germany
Research Site
Heidelberg, 69120, Germany
Research Site
Kassel, 34117, Germany
Research Site
Kassel, 34121, Germany
Research Site
Kiel, 24105, Germany
Research Site
Kleve, 47533, Germany
Research Site
Lübeck, 23560, Germany
Research Site
Mainz, 55131, Germany
Research Site
Mönchengladbach, 41063, Germany
Research Site
Münster, 48149, Germany
Research Site
Oldenburg, 26133, Germany
Research Site
Regensburg, 93053, Germany
Research Site
Rostock, 18057, Germany
Research Site
Rotenburg (Wümme), 36199, Germany
Research Site
Siegen, 57072, Germany
Research Site
Tegel, 13507, Germany
Research Site
Wuppertal, 42117, Germany
Related Publications (2)
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.
PMID: 35441926DERIVEDKrackhardt 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.
PMID: 31490566DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florian Krackhardt, MD
Charite University, Berlin, Germany
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
November 26, 2015
Study Start
February 11, 2016
Primary Completion
March 7, 2019
Study Completion
March 7, 2019
Last Updated
June 4, 2020
Record last verified: 2020-05