"Me and My Heart" Study (eMocial)

June 1, 2020 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

677

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Berka, Germany, 99437
        • Research Site
      • Bad Bevensen, Germany, 29549
        • Research Site
      • Bad Krozingen, Germany, 79189
        • Research Site
      • Barby, Germany, 39249
        • Research Site
      • Berlin, Germany, 12203
        • Research Site
      • Berlin, Germany, D-13353
        • Research Site
      • Berlin-Tegel, Germany, 13507
        • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Group B without MEMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
An average of 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
An average of 48 weeks
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)
1 year
Change in Quality of Life
Time Frame: 1 year
Change in Quality of Life assessed by Short Form 36 Questionnaire (SF-36v2)
1 year
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
An average of one year
Disease understanding and treatment awareness
Time Frame: Every four weeks during 48 weeks observational phase
Assessed according to questions 5-11 in the BAQ
Every four weeks during 48 weeks observational phase
Health care utilization
Time Frame: Every four weeks during the 48 weeks observational phase
Assessed on the questions 12-15 in the BAQ
Every four weeks during the 48 weeks observational phase

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During baseline
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
During 48 weeks observational phase
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
An average of one year
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
An average of one year
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
An average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Florian Krackhardt, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2016

Primary Completion (Actual)

March 7, 2019

Study Completion (Actual)

March 7, 2019

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5130C00161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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