The primary objective of this study is to investigate if a smart technology intervention could improve prognostic factors in patients who underwent cardiovascular surgery, more specifically earlier identification of adverse events such as sternal…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study will be the diagnosis of atrial fibrillation.
Secondary outcome
- Time to atrial fibrillation
- Diagnosis and time to cardiac decompensation
- Diagnosis and time to sternal wound infection
- Number of cardiology or thoracic surgery related, unplanned hospital visits
- Quality of life: EQ-5D questionnaires
- Score of patient satisfaction considering (e)Visits and The Box
- Anxiety (CAQ), illness perceptions (BIPQ) and engagement (TWEETS)
- Major Adverse Cardiac Events: cardiac death, myocardial infarction, cardiac
tamponade, ischaemic stroke; or TIA, defined as a transient episode of
neurological dysfunction lasting for less than 1h, caused by focal brain or
retinal ischaemia without recent infarction on cerebral imaging.15
- Mortality rate
- Re-admission rate to the cardiology or thoracic surgery ward
- Blood pressure control, which is having a systolic blood pressure of < 140
mmHg and a diastolic blood pressure of < 90 mmHg.16
- Cost-effectiveness
Background summary
Home monitoring can improve the quality of (cardiovascular) care. Recent
publications showed that increased monitoring and subsequent treatment led to a
better controlled blood pressure in patients who were treated for hypertension.
The Box study, which is currently being carried out at the LUMC, is
investigating whether patients benefit from a smart technology intervention
after they had a myocardial infarction. Preliminary (unpublished) results show
that clinical outcomes are similar, with higher patient satisfaction. Patients
who are discharged after they underwent cardiovascular surgery are at risk to
develop one or more of three most seen late complications: sternal wound
infection, cardiac decompensation or rhythm disturbances such as atrial
fibrillation. This is not always detected before those patients are discharged.
Smart technology is hypothesized to increase the chances of diagnosing rhythm
disturbances. In the case of sternal wound infection and cardiac
decompensation, smart technology may show a declining trend before a patient
visits the outpatient clinic, which can lead to early detection and treatment.
Study objective
The primary objective of this study is to investigate if a smart technology
intervention could improve prognostic factors in patients who underwent
cardiovascular surgery, more specifically earlier identification of adverse
events such as sternal wound infection, cardiac decompensation and/or
arrhythmias such as atrial fibrillation.
Study design
The design of the study is a before-after comparison, in which the 365 expected
included patients will form the intervention group.
Intervention
Introduction of eHealth: home monitoring in combination with a Webcam consult
instead of regular follow-up on the outpatient clinic.
Study burden and risks
All devices used for personal management in this study are non-invasive,
easy-to-use and electrically safe. Using the devices is without any risks
whatsoever. This study has some potential benefits for patients: first,
patients can measure their own blood pressure, temperature and weight, as well
as record their own ECG. This can reassure patients and give them more insight
in their own health (the so-called *patient empowerment*). Furthermore, this
data gives the doctor more insight in the health of patients. This might lead
to early detection of wound infection, cardiac decompensation, hypertension and
arrhythmias such as atrial fibrillation, but diagnoses are not directly based
on measurements of the personal management devices. Due to the video connection
system, patients will not have to come to the hospital while receiving the same
quality of care, which saves the patient both time and money.
In this study, we use one e-health consult in which the patient shows his or
her sternum wound. Due to this being transmitted via the internet,
precautionary measures have been taken to prevent a third party from acquiring
access to the live stream. Patients will be provided with computer software
that is especially designed for patient care (Webcamconsult®) and asked to
connect only via a protected WiFi network. During the consult, the patient is
advised to wear a (dress) shirt, so opening a few buttons provides the care
giver with enough information without showing more private parts of the
patient*s body. The video stream will not be stored.
In summary, we presented a study with almost no risks and a couple of potential
benefits for participating patients as well as for future patients. We
therefore believe this study is ethically justified.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Patient undergoes cardiovascular surgery
Patient is able to communicate in Dutch or English
Patient has been referred by a cardiologist from the Leiden University Medical
Center, Cardiological Center Voorschoten, Alrijne Hospital or Haaglanden
Medical Center
Exclusion criteria
Patient is under the age of 18 years
Patient is pregnant
Patient is considered an incapacitated adult
Patient is unwilling to sign the informed consent form
Patient undergoes emergency thoracic surgery (INTERMACS 1 or 2)
Patient has active endocarditis at the time of operation
Patient is on mechanical circulatory support before operation
Patient has a ventricular septal rupture
Patient undergoes extracorporeal membrane oxygenation or ventricular assist
device insertion
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL65959.058.18 |