Cardiac RehabilitationNCT06306235
Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation?
An observational study of Cardiac Rehabilitation, run by Jessa Hospital at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Questionnaire
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Oct 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Eligible for conventional cardiac rehabilitation
- Not willing to participate in conventional cardiac rehabilitation.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Part A: 30 patients will be interviewed. Part B: 300 patients will complete written questionnaire on tablet.
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to participate in telerehabilitation
Is the patient willing to participate in telerehabilitation? Based on question asked in interview, response will be recorded and evaluated by two independent investigators.
Measured: Immediate assessment of willingness during patient interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start12 Oct 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Dendale, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306235
- Sponsor's protocol ID
- 20.84-reva20.06
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2020
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared. Pseudonymized data might be used for statistical support.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation?
- ClinicalTrials.gov ID
- NCT06306235
- Acronym / sponsor ID
- 20.84-reva20.06
- Conditions
- Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Eligible for conventional cardiac rehabilitation
- Not willing to participate in conventional cardiac rehabilitation.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairePart A: 30 patients will be interviewed. Part B: 300 patients will complete written questionnaire on tablet. | Other | – |
Primary outcome
Willingness to participate in telerehabilitation
Time frame: Immediate assessment of willingness during patient interview.
Is the patient willing to participate in telerehabilitation? Based on question asked in interview, response will be recorded and evaluated by two independent investigators.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared. Pseudonymized data might be used for statistical support.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dendale principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to participate in telerehabilitation (time frame: Immediate assessment of willingness during patient interview.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.