Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03690492 |
Other study ID # |
NL65959.058.18 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 2, 2018 |
Est. completion date |
June 15, 2021 |
Study information
Verified date |
September 2021 |
Source |
Leiden University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The objective of this study is to determine the effect on quality of care when introducing
smart technology in patients who underwent cardiovascular surgery. Patients who consent to
take part in the study, receive a box containing two smartphone compatible ECG monitors, an
oxygen saturation monitor, a weight scale, a thermometer, an activity tracker and a blood
pressure monitor. They will be followed up by replacing one of the outpatient clinic visits
by an e-consult, in which a patients does not have to go to the hospital. Instead, he or she
will talk with his or her doctor or nurse practitioner via a secured video connection. The
primary endpoint of the study will be the diagnosis of atrial fibrillation within 3 months
after cardiac surgery.
Description:
Over the past five years, smartphone compatible detectors of cardiovascular disease
parameters have been released on the consumers market. Examples of these include heart rate
monitors, ECG monitors, blood pressure monitors, activity trackers and fat percentages
monitors. These monitors have often been validated and are CE-marked for use in the European
Union within their intended use.
Recent publications implicate that home monitoring with such consumer devices might improve
quality of care. A study by Bosworth et al. in patients with hypertension showed that
increased monitoring and subsequent treatment led to a better controlled blood pressure in
patients who were treated for hypertension. Another 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 Preliminary (unpublished) results show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. Cost analyses show that
there is a cost reduction per patient with smart technology follow-up. Therefore, smart
technology could be a useful tool to improve patient monitoring and therefore patient safety.
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.
Currently, patients who underwent cardiovascular surgery return to the outpatient clinic 14
days and three months after discharge. They are seen by a specialist nurse or cardiologist,
who will perform a general check-up and inspect the sternal wound. An echocardiogram will be
performed before the three-month visit. If there is suspicion for a rhythm disturbance on the
outpatient clinic visit, the cardiologist might decide to perform Holter monitoring during 24
hours. As this is a small window of time, not all rhythm disturbances will be diagnosed.
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.
A small pilot study by McElroy et all found that after cardiovascular surgery, both the
patient as well as the health care team are highly satisfied with added smart technology, due
to the ease of use of the technology and platform. There was a main focus on readmission
rates, which did not differ between the groups. However the trend shows an increase in
diagnosing atrial fibrillation (15,4 vs 29,6%), sternal wound infection or cardiac
decompensation were not studied.
To our knowledge, no other study has yet looked into diagnosing late complications after
cardiovascular surgery with the help of smart technology. It is hypothesized that smart
technology could help diagnose the main three diagnoses mentioned above early on and with
that, improve quality of care in patients after cardiovascular surgery. Therefore, in this
study, the clinical effectiveness of a smart technology intervention is investigated in
patients who have underwent cardiovascular surgery at the department of Thoracic Surgery at
Leiden University Medical Center.