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"Me and My Heart" Study (eMocial)

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ClinicalTrials.gov Identifier: NCT02615704
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment
Acute Coronary Syndrome Device: Active group with MEMS Device: Active group without MEMS Device: Control group with MEMS Device: Control group without MEMS

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.


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Study Type : Observational
Actual Enrollment : 657 participants
Observational Model: Other
Time Perspective: Other
Official Title: Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)
Actual Study Start Date : February 11, 2016
Actual Primary Completion Date : March 7, 2019
Actual Study Completion Date : March 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Group/Cohort Intervention/treatment
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
Device: Active group 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
Other Name: Group A 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
Device: Active group 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
Other Name: Group A 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
Device: Control group 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
Other Name: Group B 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
Device: Control group 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
Other Name: Group B without MEMS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of tablets taken during the observation phase [ Time Frame: An average of 48 weeks ]
    Tablets taken measured by a Medical Event Monitoring System (MEMS) to record a time stamp for every tablets taken

  2. The percent change in key risk factors [ Time Frame: 1 year ]
    Key risk factors like blood pressure, laboratory parameters (if available: LDL cholesterol, HDL cholesterol, HbA1c, body weight, and BMI)

  3. Change in Quality of Life [ Time Frame: 1 year ]
    Change in Quality of Life assessed by Short Form 36 Questionnaire (SF-36v2)

  4. Change in patient reported lifestyle changes [ Time Frame: An average of one year ]
    Lifestyle changes assessed by a Lifestyle Changes Questionnaire (LSQ) at V1 and V2 (patient reported outcome (PRO) instrument

  5. Disease understanding and treatment awareness [ Time Frame: Every four weeks during 48 weeks observational phase ]
    Assessed according to questions 5-11 in the BAQ

  6. Health care utilization [ Time Frame: Every four weeks during the 48 weeks observational phase ]
    Assessed on the questions 12-15 in the BAQ


Other Outcome Measures:
  1. Cardiovascular risk score GRACE 2.0 [ Time Frame: During baseline ]
    Impact of GRACE 2.0 risk score at baseline on adherence as assessed by BAQ

  2. Treatment gaps according to missed tablets obtained in the subgroup of patients equipped [ Time Frame: During 48 weeks observational phase ]
    Missed tablets (based on MEMS) compared between randomized groups

  3. Patients' report on the use of alternative medication reminder or other health APPs [ Time Frame: An average of one year ]
    Usage of other medication reminder or health apps

  4. For the active treatment group, data on the use of the patient support tool [ Time Frame: An average of one year ]
    The number of times the APP is used during the study through an analysis of the recorded user data

  5. For the active treatment group, responses to the questions of the System Usability Scale (SUS) [ Time Frame: An average of one year ]
    Assessment of SUS replies at visit 2



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615704


Locations
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Germany
Research Site
Bad Berka, Germany, 99437
Research Site
Bad Bevensen, Germany, 29549
Research Site
Bad Krozingen, Germany, 79189
Research Site
Barby, Germany, 39249
Research Site
Berlin-Tegel, Germany, 13507
Research Site
Berlin, Germany, 12203
Research Site
Berlin, Germany, D-13353
Research Site
Bernau, Germany, 16321
Research Site
Chemnitz, Germany, 09116
Research Site
Coburg, Germany, 96450
Research Site
Düsseldorf, Germany, 40217
Research Site
Erkrath, Germany, 40699
Research Site
Essen, Germany, 45219
Research Site
Frankfurt, Germany, 65929
Research Site
Gelsenkirchen, Germany, 45891
Research Site
Hamburg, Germany, 20099
Research Site
Heidelberg, Germany, 69120
Research Site
Kassel, Germany, 34117
Research Site
Kassel, Germany, 34121
Research Site
Kiel, Germany, 24105
Research Site
Kleve, Germany, 47533
Research Site
Lübeck, Germany, 23560
Research Site
Mainz, Germany, 55131
Research Site
Mönchengladbach, Germany, 41063
Research Site
Münster, Germany, 48149
Research Site
Oldenburg, Germany, 26133
Research Site
Regensburg, Germany, 93053
Research Site
Rostock, Germany, 18057
Research Site
Rotenburg, Germany, 36199
Research Site
Siegen, Germany, 57072
Research Site
Wuppertal, Germany, 42117
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Florian Krackhardt, MD Charite University, Berlin, Germany

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02615704     History of Changes
Other Study ID Numbers: D5130C00161
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

Keywords provided by AstraZeneca:
Brilique treatment adherence via electronic device application (APP)

Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Aspirin
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics