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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • Jessa Hospital

    Hasselt, Limburg, 3500

Other trials in Belgium

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.

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.

  1. 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.

  1. First posted12 Mar 2024
  2. Study start12 Oct 2020
  3. Primary completion31 Jul 2021
  4. Study completion31 Jul 2021

Resources

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)
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.

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.

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