PMID- 31490566
OWN - NLM
STAT- MEDLINE
DCOM- 20200324
LR  - 20210110
IS  - 1932-8737 (Electronic)
IS  - 0160-9289 (Print)
IS  - 0160-9289 (Linking)
VI  - 42
IP  - 11
DP  - 2019 Nov
TI  - 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.
PG  - 1054-1062
LID - 10.1002/clc.23254 [doi]
AB  - A novel smartphone-based patient support tool was developed to increase the 
      adherence to antiplatelet therapy and lifestyle changes in patients after 
      coronary angioplasty for acute coronary syndrome (ACS). The eMocial study 
      (ClinicalTrials.gov Identifier: NCT02615704) investigates whether an electronic 
      support tool will improve adherence to comedication and lifestyle changes in ACS 
      patients. The primary hypothesis of this trial is that an electronic support tool 
      can increase adherence to comedication (primary endpoint) thereby supporting 
      positive lifestyle changes (secondary endpoints). Patients hospitalized with ACS 
      (ST elevation myocardial infarction [STEMI], non-ST elevation myocardial 
      infarction [NSTEMI], or unstable angina pectoris) and treated with ticagrelor 
      coadministered with low-dose acetylsalicylic acid will be randomized 1:1 to an 
      active group receiving the patient support tool via a smartphone-based 
      application or to a control group without the patient support tool. Patient 
      questionnaires to evaluate lifestyle changes and quality of life will be used at 
      baseline and at the end of the 48-week observation phase. Patients are asked to 
      fill out questionnaires to determine their adherence, treatment attitudes, 
      health-care utilization and risk factors on a monthly basis. The study was 
      started in February 2016 and the completion date is scheduled for October 2019. 
      For final analysis 664 patients are expected be available. Preliminary baseline 
      demographics were unstable angina pectoris (13.7%), NSTEMI (49.9%), STEMI 
      (36.4%), male gender (86.3%), and diabetes mellitus (17.6%). Our study could 
      significantly help to understand how inadequate adherence to antiplatelet therapy 
      in ACS patients could be improved with a smartphone-based application.
CI  - (c) 2019 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc.
FAU - Krackhardt, Florian
AU  - Krackhardt F
AUID- ORCID: 0000-0001-5965-8817
AD  - Department of Internal Medicine and Cardiology, Charite Campus Virchow-Klinikum, 
      Charite University Medicine Berlin, Berlin, Germany.
FAU - Maier, Lars S
AU  - Maier LS
AD  - Klinik und Poliklinik fur Innere Medizin II, Universitatsklinikum Regensburg, 
      Regensburg, Germany.
FAU - Appel, Karl-Friedrich
AU  - Appel KF
AD  - Ambulantes Herzzentrum Kassel, Kassel, Germany.
FAU - Kohler, Till
AU  - Kohler T
AD  - Universitatslinikum Wuppertal, Wupperthal, Germany.
FAU - Ghanem, Alexander
AU  - Ghanem A
AD  - Asklepios Klinik St. Georg, Hamburg, Germany.
FAU - Tschoepe, Carsten
AU  - Tschoepe C
AD  - Department of Internal Medicine and Cardiology, Charite Campus Virchow-Klinikum, 
      Charite University Medicine Berlin, Berlin, Germany.
FAU - Dahl, Jurgen Vom
AU  - Dahl JV
AD  - Kliniken Maria Hilf GmbH/Medizinische Klinik II, Monchengladbach, Germany.
FAU - Degenhardt, Ralf
AU  - Degenhardt R
AD  - Institut fur Klinische Forschung Herz- und Kreislaufzentrum GmbH, Fulda, Germany.
FAU - Niklasson, Anna
AU  - Niklasson A
AD  - AstraZeneca R&D Gothenburg, Gothenburg, Sweden.
FAU - Ahlqvist, Matti
AU  - Ahlqvist M
AD  - AstraZeneca R&D Gothenburg, Gothenburg, Sweden.
FAU - Waliszewski, Matthias W
AU  - Waliszewski MW
AUID- ORCID: 0000-0002-8689-4505
AD  - Department of Internal Medicine and Cardiology, Charite Campus Virchow-Klinikum, 
      Charite University Medicine Berlin, Berlin, Germany.
FAU - Jornten-Karlsson, Magnus
AU  - Jornten-Karlsson M
AD  - AstraZeneca R&D Gothenburg, Gothenburg, Sweden.
LA  - eng
SI  - ClinicalTrials.gov/NCT02615704
GR  - AstraZeneca/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190906
PL  - United States
TA  - Clin Cardiol
JT  - Clinical cardiology
JID - 7903272
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - GLH0314RVC (Ticagrelor)
SB  - IM
MH  - Acute Coronary Syndrome/*therapy
MH  - Angioplasty, Balloon, Coronary/methods
MH  - Electrocardiography
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Patient Compliance
MH  - Platelet Aggregation Inhibitors/therapeutic use
MH  - Postoperative Period
MH  - Quality of Life
MH  - Retrospective Studies
MH  - *Smartphone
MH  - Surveys and Questionnaires
MH  - Telemedicine/*methods
MH  - Ticagrelor/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC6837026
OTO - NOTNLM
OT  - acute coronary syndrome
OT  - adherence
OT  - dual anti-platelet therapy (DAPT)
OT  - smartphone-based support
OT  - study design
OT  - ticagrelor
COIS- FK received lecture fees from AstraZenecax, MJ-K, AN, MA are full-time employees 
      of AstraZeneca during the preparation of this manuscript. All other authors have 
      no conflict of interest.
EDAT- 2019/09/07 06:00
MHDA- 2020/03/25 06:00
PMCR- 2019/09/06
CRDT- 2019/09/07 06:00
PHST- 2019/06/26 00:00 [received]
PHST- 2019/08/22 00:00 [revised]
PHST- 2019/08/26 00:00 [accepted]
PHST- 2019/09/07 06:00 [pubmed]
PHST- 2020/03/25 06:00 [medline]
PHST- 2019/09/07 06:00 [entrez]
PHST- 2019/09/06 00:00 [pmc-release]
AID - CLC23254 [pii]
AID - 10.1002/clc.23254 [doi]
PST - ppublish
SO  - Clin Cardiol. 2019 Nov;42(11):1054-1062. doi: 10.1002/clc.23254. Epub 2019 Sep 6.