Cardiovascular DiseasesMEDICARNCT05337020
Survey on the Future of Telemedicine in the Daily Care of Cardiology Patients.
A study testing Survey in people with Cardiovascular Diseases, run by University Hospital, Antwerp at 2 sites in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 2 sitesBelgium
- Study dates
- 16 Mar 2022to 23 Aug 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have had a follow-up at the cardiology department of Jessa Hospital Hasselt or UZA
- Participants over the age of 18 years
Who cannot join
- Participants who are not able to read or fully understand Dutch
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Antwerp University hospital
Edegem, Limburg, 2650
Jessa Hospital Hasselt
Hasselt, Limburg, 3500
About this study
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Survey
- Keywords
- Telemedicine
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Each patient will be asked to fill in the questionnaire to assess their vision on telemedicine
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 240 patients will receive the questionnaire to assess patients vision on telemedicine. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire to assess enablers and barriers to use telemedicine
to assess the enablers and barriers to the use of telemedicine.
Measured: day 1
Questionnaire to assess willingness to pay for telemedicine tools
to explore the willingness to pay for such telemedicine tools.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start16 Mar 2022
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337020
- Sponsor's protocol ID
- 21-1945
- Acronym
- MEDICAR
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on the Future of Telemedicine in the Daily Care of Cardiology Patients.
- ClinicalTrials.gov ID
- NCT05337020
- Acronym / sponsor ID
- MEDICAR / 21-1945
- Conditions
- Cardiovascular Diseases
- Keywords
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 20 Apr 2022 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Survey240 patients will receive the questionnaire to assess patients vision on telemedicine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have had a follow-up at the cardiology department of Jessa Hospital Hasselt or UZA
- Participants over the age of 18 years
Key exclusion criteria (1 listed)
- Participants who are not able to read or fully understand Dutch
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 |
|---|---|---|
| SurveyEach patient will be asked to fill in the questionnaire to assess their vision on telemedicine | Other | Intervention group |
Primary outcome
Questionnaire to assess enablers and barriers to use telemedicine
Time frame: day 1
to assess the enablers and barriers to the use of telemedicine.
Questionnaire to assess willingness to pay for telemedicine tools
Time frame: day 1
to explore the willingness to pay for such telemedicine tools.
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 9 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey in people with Cardiovascular Diseases, run by University Hospital, Antwerp at 2 sites 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Questionnaire to assess enablers and barriers to use telemedicine (time frame: day 1). The study lists 2 primary outcomes in all. 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 9 Nov 2022.