Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06306235 |
Other study ID # |
20.84-reva20.06 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 12, 2020 |
Est. completion date |
July 31, 2021 |
Study information
Verified date |
October 2022 |
Source |
Jessa Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Patients who are eligible for cardiac rehabilitation but do not want to participate will be
offered to participate in an interview (part A of the study) or a tablet questionnaire (part
B of the study).
Goal is to identify main barriers for conventional rehabilitation as well as to assess
willingness to participate in cardiac telerehabilitation, main barriers and
willingness-to-pay for cardiac telerehabilitation.
Description:
Cardiac rehabilitation (CR) is indicated in patients with a wide range of cardiovascular
diseases. Its benefits are well-studied and participation in CR is thus stated as a Class IA
recommendation in the 2016 European Guidelines on cardiovascular disease prevention in
clinical practice. It is known however that participation rates are low. This is due to
multiple factors such as health system barriers (e.g. lack of referral by doctors), as well
as patient factors (eg. travelling time to hospital).
Telerehabilitation is a modality of cardiac rehabilitation that is widely studied to overcome
barriers in conventional cardiac rehabilitation. Most studies about telerehabilitation screen
for potential rehabilitation candidates, ask which patients are prepared to start
centre-based rehabilitation and then start randomisation for centre-based or home-based
rehabilitation.
The hypothesis is that by offering a home-based alternative for centre-based rehabilitation,
patient participation rates will go up. However, this hypothesis has not been investigated.
The willingness to participate in patients that refuse centre-based rehabilitation is thus
scarcely studied.
This study aims to assess the willingness to participate in telerehabilitation in patients
that refuse conventional centre-based rehabilitation as well as the main reasons not to
participate in centre-based rehabilitation.
Methods
Patients that are eligible for participating in cardiac rehabilitation will be offered to do
so as usual. Those who do not wish to participate or are not sure whether they will
participate in cardiac rehabilitation will be asked to participate in this study.
The first part of this study is a pilot part in which 30 patients will be included. These
patients will be interviewed by one of the researchers (dr. Maarten Falter or dr. Martijn
Scherrenberg). A semi-structured interview of 20 minutes will be performed to assess the most
important barriers for rehabilitation, willingness-to-pay and possible barriers for
telerehabilitation, as well as patient profile and socio-economic background. Informed
consent will also be asked to collect patient data from the hospital records (age, gender,
cardiac disease, cardiac index event, cardiac device implanted, indication for
rehabilitation, date of primary cardiac event, length of hospital stay, cardiac
rehabilitation history, procedures performed, comorbidities, distance from home to hospital,
Mobiscore, smoking status, length, weight, medication, ejection fraction) as these factors
are possible determinants of the outcome of our study.
The second part of this study is a survey that will assess the most important barriers in 300
patients. This survey will be constructed using the main barriers found in literature in
combination with main barriers mentioned by the pilot population. The survey will consist of
multiple-choice questions and will again assess main barriers for participating in
rehabilitation and telerehabilitation. The survey will be completed using an iPad from the
cardiology department using Qualtrics while the patient is still in the hospital. The
Qualtrics license is obtained via Hasselt University. Informed consent will also be asked to
collect patient data from the hospital records (see variables above).
All study results will be stored on a secured drive of Jessa hospital (K-drive). Only the
health professionals with a therapeutic relation, the principal investigator and the local
investigator can access this list. Data will be converted into a pseudonymized database for
further statistical analysis in collaboration with the University of Hasselt or for analysis
in collaboration with bachelor students of the University of Hasselt. Patients will only be
included in the Jessa hospital.