Acute Coronary SyndromeeMocialNCT02615704
"Me and My Heart" Study
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 31 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Active group with MEMS and Active group without MEMS
- Type of treatment
- Medical device
- How many people
- 677 participants
- Where
- 31 sitesGermany
- Study dates
- 11 Feb 2016to 7 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Germany31 sites
Research Site
Bad Berka, 99437
Research Site
Bad Bevensen, 29549
Research Site
Bad Krozingen, 79189
Research Site
Barby, 39249
Research Site
Berlin, 12203
Research Site
Berlin, D-13353
Research Site
Bernau, 16321
Research Site
Chemnitz, 09116
Research Site
Coburg, 96450
Research Site
Düsseldorf, 40217
Research Site
Erkrath, 40699
Research Site
Essen, 45219
Research Site
Frankfurt, 65929
Research Site
Gelsenkirchen, 45891
Research Site
Hamburg, 20099
Research Site
Heidelberg, 69120
Research Site
Kassel, 34117
Research Site
Kassel, 34121
Research Site
Kiel, 24105
Research Site
Kleve, 47533
Research Site
Lübeck, 23560
Research Site
Mainz, 55131
Research Site
Mönchengladbach, 41063
Research Site
Münster, 48149
Research Site
Oldenburg, 26133
Research Site
Regensburg, 93053
Research Site
Rostock, 18057
Research Site
Rotenburg (Wümme), 36199
Research Site
Siegen, 57072
Research Site
Tegel, 13507
Research Site
Wuppertal, 42117
About this study
Official title: Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)
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
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Active group with MEMS, Active group without MEMS, Control group with MEMS, Control group without MEMS
- Keywords
- Brilique treatment adherence via electronic device application (APP)
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active group with MEMSDevice
Also called Group A 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
Active group without MEMSDevice
Also called Group A 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
Control group with MEMSDevice
Also called Group B 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
Control group without MEMSDevice
Also called Group B 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Active group 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 Receives: Device: Active group 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 Receives: Device: Control group 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 Receives: Device: Control group without MEMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of 48 weeks
Secondary outcomes (6)
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
Measured: 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)
Measured: 1 year
Change in Quality of Life
Change in Quality of Life assessed by Short Form 36 Questionnaire (SF-36v2)
Measured: 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
Measured: An average of one year
Disease understanding and treatment awareness
Assessed according to questions 5-11 in the BAQ
Measured: Every four weeks during 48 weeks observational phase
Health care utilization
Assessed on the questions 12-15 in the BAQ
Measured: Every four weeks during the 48 weeks observational phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start11 Feb 2016
- Primary completion7 Mar 2019
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Florian Krackhardt, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615704
- Sponsor's protocol ID
- D5130C00161
- Acronym
- eMocial
- Status last verified
- May 2020
- First submitted
- 11 Nov 2015
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35441926Krackhardt 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.
PubMed 31490566
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)
- ClinicalTrials.gov ID
- NCT02615704
- Acronym / sponsor ID
- eMocial / D5130C00161
- Conditions
- Acute Coronary Syndrome
- Keywords
- Brilique treatment adherence via electronic device application (APP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 26 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active APP with MEMS | – | Device: Active group with MEMSACS 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 | – | Device: Active group without MEMSACS 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 | – | Device: Control group with MEMSACS 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 | – | Device: Control group without MEMSACS 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 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active group with MEMSAlso: Group A with MEMSPatients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool and with MEMS | Device | Active APP with MEMS |
| Active group without MEMSAlso: Group A without MEMSPatients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool but without MEMS | Device | Active APP without MEMs |
| Control group with MEMSAlso: Group B with MEMSPatients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool but with MEMS | Device | Control APP with MEMS |
| Control group without MEMSAlso: Group B without MEMSPatients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool and without MEMS | Device | Control APP without MEMS |
Primary outcome
Percentage of tablets taken during the observation phase
Time frame: An average of 48 weeks
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.
6 secondary outcomes
Percentage of tablets taken during the observation phase
Time frame: An average of 48 weeks
The percent change in key risk factors
Time frame: 1 year
Change in Quality of Life
Time frame: 1 year
Change in patient reported lifestyle changes
Time frame: An average of one year
Disease understanding and treatment awareness
Time frame: Every four weeks during 48 weeks observational phase
Health care utilization
Time frame: Every four weeks during the 48 weeks observational phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 35441926Krackhardt 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.
- Derived from this study: PubMed 31490566Krackhardt 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.
- D5130C00161 CSR Synopsis RedactedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Krackhardt, MD principal investigator
Charite University, Berlin, Germany
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 31 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of tablets taken during the observation phase (time frame: An average of 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02615704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.