Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05337020 |
Other study ID # |
21-1945 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 16, 2022 |
Est. completion date |
August 23, 2022 |
Study information
Verified date |
March 2022 |
Source |
University Hospital, Antwerp |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The Cardiology research group at the Jessa Hospital Hasselt and the University Hospital
Antwerp (in collaboration with the University of Hasselt and the University of Antwerp) is
conducting research into remote patient monitoring (telemedicine). Digital technologies such
as smartphones, tablets, fitness trackers, smartwatches,… make it easier to monitor the
health of cardio patients between consultations. This would allow for faster intervention
when necessary, but consultations can also (partially) take place remotely. For this study,
we are looking for patients who have already used such technologies to remotely monitor their
health and patients who have never used it before.
We would like to find out how these patients feel about telemedicine by means of a
questionnaire. This will take approximately 5 to 10 minutes. In this way, we can gain a
better understanding of these patients' views and expectations regarding telemedicine. In
this way we can further improve healthcare and develop more options to follow up patients
even better from your home environment.
Description:
The main aim of this study is to evaluate the overall perception of cardiology patients
concerning telemedicine features and services in two patient groups: patients who had already
any kind of telemedicine follow-up and a small population which never made us of a
telemedicine follow-up.
More specifically the aims are:
- to assess the enablers and barriers to the use of telemedicine.
- to explore the willingness to pay for such telemedicine tools.
This is a multicentric, prospective study performed at Jessa Hospital Hasselt, Belgium and
Antwerp University Hospital (UZA), Belgium in which a newly developed questionnaire (Appendix
1) will be used. It takes about 5-10 minutes to fill in the survey. The questionnaire
contains 6 parts:
- General information on the patients and the use of telemedicine tools
- Questions about the importance of functions and services in telemedicine tools
- Questions about enablers to use telemedicine
- Questions on the ease-of-use of such technologies
- Questions on barriers using telemedicine
- Questions on the willingness to pay for such telemedicine tools.
Two patient groups will be included: 1. Patients who already had a telemonitoring follow-up
in the past and 2. Patients who have never been followed with a telemonitoring tool (except
for teleconsultations during COVID-19 without any other telemedicine tools) as a control
group. There are at least 2000 patients in Jessa and UZA who have had a form of
telemonitoring in the past years (from 2014 untill now): i.e. patients with a cardiovascular
implantable electronic device (CIED) followed by the telemonitoring unit, atrial fibrillation
patients who received personal follow-up via education or therapy adherence monitoring,
patients who received remote heart rhythm monitoring during COVID, patients who participated
in telerehabilitation projects and heart failure patients who received intensive
telemonitoring via an online platform.
Two recruitment strategies will be applied. Patients who already have had a mHealth follow-up
both at Jessa or UZA and are available in a database of the cardiology ward will be
approached to participate in this study by phone contact and asked if they want to
participate via a link sent via email. If they agree, an email with a link to the
questionnaire (Appendix 2) will be sent to these patients. After they approve with the
digital informed consent (IFC), they can fill in the questionnaire. Patients who are present
at the hospital for an in-person device consultation or hospitalized patients/patients coming
for a consultation without a telemonitoring follow-up method in the past will be approached
in-person. After a short introduction about the project, the patients will be asked to
participate in the study. These patients can approve with the digital IFC after which they
can fill in the questionnaire via the tablet in the hospital. A list will be kept of patients
who have been approached to avoid patients being asked twice as the questionnaire will be
anonymous. In this list, only patients name, first name and patient number will be added. No
additional visits are necessary for both recruitment groups. A sample size calculation for
this study is not applicable as this is an observational study that includes all eligible
patients from mHealth databases available at the cardiology ward or patients coming for an
in-person follow-up (at a device consultation)/hospitalized patients. However, the aim is to
reach 240 completed forms with at least 40 completed forms in every telemedicine group and
the control group. Therefore, specific Qualtrics links will be used for each telemedicine
group and a specific link for the control group. This is only for the analyses and sample
size. The questionnaire will be the same through all qualtrics links.