"Me and My Heart" Study

Acute Coronary Syndrome Clinical Trial

— eMocial  

Official title:

Evaluation of an Electronic Device Based Support Tool for ACS Patients: Brilique (Ticagrelor) Treatment Adherence (eMocial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615704
• Other study ID #: D5130C00161
• Status: Completed
• Start date: February 11, 2016
• Est. completion date: March 7, 2019

Study information

• Verified date: May 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: March 7, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Germany	Research Site	Bad Berka
Germany	Research Site	Bad Bevensen
Germany	Research Site	Bad Krozingen
Germany	Research Site	Barby
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin-Tegel
Germany	Research Site	Bernau
Germany	Research Site	Chemnitz
Germany	Research Site	Coburg
Germany	Research Site	Düsseldorf
Germany	Research Site	Erkrath
Germany	Research Site	Essen
Germany	Research Site	Frankfurt
Germany	Research Site	Gelsenkirchen
Germany	Research Site	Hamburg
Germany	Research Site	Heidelberg
Germany	Research Site	Kassel
Germany	Research Site	Kassel
Germany	Research Site	Kiel
Germany	Research Site	Kleve
Germany	Research Site	Lübeck
Germany	Research Site	Mainz
Germany	Research Site	Mönchengladbach
Germany	Research Site	Münster
Germany	Research Site	Oldenburg
Germany	Research Site	Regensburg
Germany	Research Site	Rostock
Germany	Research Site	Rotenburg
Germany	Research Site	Siegen
Germany	Research Site	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular risk score GRACE 2.0	Impact of GRACE 2.0 risk score at baseline on adherence as assessed by BAQ	During baseline
Other	Treatment gaps according to missed tablets obtained in the subgroup of patients equipped	Missed tablets (based on MEMS) compared between randomized groups	During 48 weeks observational phase
Other	Patients' report on the use of alternative medication reminder or other health APPs	Usage of other medication reminder or health apps	An average of one year
Other	For the active treatment group, data on the use of the patient support tool	The number of times the APP is used during the study through an analysis of the recorded user data	An average of one year
Other	For the active treatment group, responses to the questions of the System Usability Scale (SUS)	Assessment of SUS replies at visit 2	An average of one year
Primary	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	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	An average of 48 weeks
Secondary	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)	1 year
Secondary	Change in Quality of Life	Change in Quality of Life assessed by Short Form 36 Questionnaire (SF-36v2)	1 year
Secondary	Change in patient reported lifestyle changes	Lifestyle changes assessed by a Lifestyle Changes Questionnaire (LSQ) at V1 and V2 (patient reported outcome (PRO) instrument	An average of one year
Secondary	Disease understanding and treatment awareness	Assessed according to questions 5-11 in the BAQ	Every four weeks during 48 weeks observational phase
Secondary	Health care utilization	Assessed on the questions 12-15 in the BAQ	Every four weeks during the 48 weeks observational phase

External Links

•   D5130C00161 CSR Synopsis Redacted