PMID- 28939546
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1929-0748 (Print)
IS  - 1929-0748 (Electronic)
IS  - 1929-0748 (Linking)
VI  - 6
IP  - 9
DP  - 2017 Sep 22
TI  - Using Smart Technology to Improve Outcomes in Myocardial Infarction Patients: 
      Rationale and Design of a Protocol for a Randomized Controlled Trial, The Box.
PG  - e186
LID - 10.2196/resprot.8038 [doi]
LID - e186
AB  - BACKGROUND: Recent evidence suggests that frequent monitoring using 
      smartphone-compatible wearable technologies might improve clinical effectiveness 
      and patient satisfaction of care. OBJECTIVE: The aim of this study is to 
      investigate the clinical effectiveness and patient satisfaction of a smart 
      technology intervention in patients admitted with a ST elevation myocardial 
      infarction (STEMI) or non-ST acute coronary syndrome (NST-ACS). METHODS: In this 
      single center, open, randomized controlled trial patients who suffered from STEMI 
      or NST-ACS will be randomized 1:1 to an intervention group or control group. Both 
      groups will be followed up to one year after the index event. The intervention 
      group will take daily measurements with a smartphone-compatible electrocardiogram 
      device, blood pressure (BP) monitor, weight scale, and activity tracker. 
      Furthermore, two of four outpatient clinic visits will be replaced by electronic 
      visits (1 and 6 months after index event). The control group will receive regular 
      care, consisting of four outpatient clinic visits (1, 3, 6, and 12 months after 
      index event). All patients will be asked to fill in validated questionnaires 
      about patient satisfaction, quality of life, propensity of medication adherence, 
      and physical activity. RESULTS: The primary outcome of this trial will be 
      percentage of patients with controlled BP. Secondary outcomes include patient 
      satisfaction, health care utilization, major adverse cardiac events, medication 
      adherence, physical activity, quality of life, and percentage of patients in 
      which a sustained arrhythmia is detected. CONCLUSIONS: Smart technology could 
      potentially improve care in postmyocardial infarction patients. This trial will 
      investigate whether usage of smart technology can improve clinical- and 
      cost-effectiveness of care. TRIAL REGISTRATION: Clinicaltrials.gov NCT02976376; 
      https://clinicaltrials.gov/ct2/show/NCT02976376 (Archived by WebCite at 
      http://www.webcitation.org/6tcvAdbdH).
CI  - (c)Roderick Willem Treskes, Louise Anna van Winden, Nicole van Keulen, Douwe Ekke 
      Atsma, Enno Tjeerd van der Velde, Elske van den Akker-van Marle, Bart Mertens, 
      Martin Jan Schalij. Originally published in JMIR Research Protocols 
      (http://www.researchprotocols.org), 22.09.2017.
FAU - Treskes, Roderick Willem
AU  - Treskes RW
AUID- ORCID: 0000-0003-3210-6005
AD  - Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
FAU - van Winden, Louise Anna
AU  - van Winden LA
AUID- ORCID: 0000-0003-2188-0185
AD  - Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
FAU - van Keulen, Nicole
AU  - van Keulen N
AUID- ORCID: 0000-0002-6664-1324
AD  - Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
FAU - Atsma, Douwe Ekke
AU  - Atsma DE
AUID- ORCID: 0000-0002-9664-2985
AD  - Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
FAU - van der Velde, Enno Tjeerd
AU  - van der Velde ET
AUID- ORCID: 0000-0002-0027-8059
AD  - Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
FAU - van den Akker-van Marle, Elske
AU  - van den Akker-van Marle E
AUID- ORCID: 0000-0002-5269-509X
AD  - Department of Medical Decision Making, Leiden University Medical Center, Leiden, 
      Netherlands.
FAU - Mertens, Bart
AU  - Mertens B
AUID- ORCID: 0000-0002-5019-0354
AD  - Department of Medical Statistics, Leiden University Medical Center, Leiden, 
      Netherlands.
FAU - Schalij, Martin Jan
AU  - Schalij MJ
AUID- ORCID: 0000-0003-3767-5231
AD  - Department of Cardiology, Leiden University Medical Center, Leiden, Netherlands.
LA  - eng
SI  - ClinicalTrials.gov/NCT02976376
PT  - Journal Article
DEP - 20170922
PL  - Canada
TA  - JMIR Res Protoc
JT  - JMIR research protocols
JID - 101599504
PMC - PMC5630694
OTO - NOTNLM
OT  - hypertension
OT  - myocardial infarction
OT  - telemedicine
COIS- Conflicts of Interest: None declared.
EDAT- 2017/09/25 06:00
MHDA- 2017/09/25 06:01
PMCR- 2017/09/22
CRDT- 2017/09/24 06:00
PHST- 2017/05/15 00:00 [received]
PHST- 2017/07/21 00:00 [accepted]
PHST- 2017/07/19 00:00 [revised]
PHST- 2017/09/24 06:00 [entrez]
PHST- 2017/09/25 06:00 [pubmed]
PHST- 2017/09/25 06:01 [medline]
PHST- 2017/09/22 00:00 [pmc-release]
AID - v6i9e186 [pii]
AID - 10.2196/resprot.8038 [doi]
PST - epublish
SO  - JMIR Res Protoc. 2017 Sep 22;6(9):e186. doi: 10.2196/resprot.8038.