Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2025-12-28 @ 12:59 AM
Study NCT ID:
NCT06306235
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2020-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation?
Sponsor:
Jessa Hospital
Organization:
Study Overview
Official Title:
Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation?
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: