- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06359132
mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients. (TeleConvert-AF)
The Effect of Integrated Mobile Health-supported Heart Rhythm Management Around Electrical Cardioversion in Terms of Cancelling Unnecessary Scheduled ECV Appointments in Patients With Presumed Persistent Atrial Fibrillation (TeleConvert-AF)
Study Overview
Status
Detailed Description
When putted on the waiting list for ECV (at baseline), the case-coordinator (investigator or nurse) will contact the patient and provide an mHealthprescription, manual and app-activation QR-code to use the CE-marked mobile phone app using photoplethysmography (PPG) technology through the built-in mobile phone's camera to monitor rate and rhythm. After 24-hours the case-coordinator will check whether the patient activated the app, otherwise will contact patient for further support.
Recordings from the device will be sent to a secure cloud application. This cloud application is equipped with an automatic analyses algorithm with a red-amber-green alert system. Patients will be asked to use the app 3-times a day and in case of symptom onset and disappearance while being on the waiting list for ECV. In case of amber alert (recording in asystole > 5 sec, tachycardia > 170 bpm, bradycardia 110 bpm) the subject's care team will be notified of the alert by the investigators within one workday. The subject will then be contacted by the care team to intensify rate control if necessary. Subjects also have the possibility to contact the investigators directly if needed. In case of green alert (SR recording), the investigators will process the alert within one workweek. The subject will then be contacted by the investigators to visit the hospital and execute a 12-lead ECG to confirm SR as soon as possible. When SR is confirmed by ECG, scheduled ECV will be cancelled by the treating physician and rate/rhythm control medication might be intensified, this is part of standard care. When SR is not confirmed by ECG, treatment decisions will remain to the treating physician and he/she will decide whether or not to cancel scheduled ECV (based on PPG recordings). In the 4-weeks following scheduled ECV appointment, all patients will receive remote semi-continuous app-based rate/rhythm monitoring including red-amber- green alert notifications and will be asked to use the app 3-times a day and in case of symptom onset and disappearance. In case of an amber alert, the subject's care team will be notified of the alert by the investigators within one workday. The subject will then be contacted by the care team to intensify rate control if necessary. Subjects also have the possibility to contact the investigators directly if needed. Of importance is that alerts will only be assessed by the investigators during office hours. Patients will specifically (both verbally and written) be informed that in case of alarming symptoms during or outside of office hours, emergency services or their own general practitioner should be contacted. In all cases of acute emergencies, a patient should contact the emergency services. Furthermore, patients will be asked to fulfill a self-composed questionnaire based on the System Usability Scale extended with additional questions to assess the usability and user-friendliness of the refined TeleCheck-AF approach around ECV at 4-week follow-up. Also a self-composed questionnaire based on the HADS-A scale will be used to assess anxiety while using the mHealth-based refined TeleCheck-AF approach around ECV at four weeks.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dominik Linz, dr.
- Phone Number: 043-3877098
- Email: dominik.linz@mumc.nl
Study Contact Backup
- Name: Astrid Hermans, MSc
- Phone Number: 043-3871613
- Email: astrid.hermans@mumc.nl
Study Locations
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-
Limburg
-
Maastricht, Limburg, Netherlands
- Recruiting
- Maastricht University Medical Center
-
Contact:
- Dominik Linz
- Phone Number: 043-3877098
- Email: dominik.linz@mumc.nl
-
Contact:
- Astrid Hermans
- Phone Number: 043-3871613
- Email: astrid.hermans@mumc.nl
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Venlo, Limburg, Netherlands
- Recruiting
- Viecuri Medical Center
-
Contact:
- Wilfred Heesen
- Phone Number: (077) 320 56 04
- Email: wheesen@viecuri.nl
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Presumed persistent AF
- Scheduled for ECV
- Age ≥18 years
- Smartphone possession
- Ability and willing to sign informed consent
- Ability and willing to use mobile phone app (FibriCheck)
Exclusion Criteria:
- Deemed unsuitable for participation by attending physician
- Presence of an active implanted electronic cardiac device
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
TeleConvert-AF
Patients with presumed persistent AF, age ≥18 years, scheduled for ECV, and in possession of a smartphone will be included in this study from January 2022 to January 2025.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV unnecessary scheduled ECV appointments
Time Frame: through study completion, an average of 8 weeks
|
The number of cancelled unnecessary scheduled ECV appointments in patients with presumed persistent AF scheduled for ECV
|
through study completion, an average of 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions
Time Frame: through study completion, an average of 8 weeks
|
Number of patients that agreed the refined TeleCheck-AF approach is usable and userfriendly as assessed by the System Usability Scale questionnaire extended with additional questions
|
through study completion, an average of 8 weeks
|
Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire
Time Frame: through study completion, an average of 8 weeks
|
Number of patients that agreed the refined TeleCheck-AF approach is anxious as assessed by the HADS-A scale questionnaire
|
through study completion, an average of 8 weeks
|
Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments
Time Frame: through study completion, an average of 8 weeks
|
Amount of saved costs for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments
|
through study completion, an average of 8 weeks
|
Number of patients with paroxysmal AF
Time Frame: through study completion, an average of 8 weeks
|
Number of patients with paroxysmal AF assessed by the refined by the on-demand heart rate and rhythm monitoring application
|
through study completion, an average of 8 weeks
|
Time to recurrence of AF
Time Frame: up to 4 weeks after ECV
|
Time to recurrence of AF
|
up to 4 weeks after ECV
|
Time period of monitoring heart rate and rhythm using the mHealth-based application
Time Frame: through study completion, an average of 8 weeks
|
Time period of monitoring heart rate and rhythm using the mHealth-based application
|
through study completion, an average of 8 weeks
|
Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments
Time Frame: through study completion, an average of 8 weeks
|
Amount of burden for the hospitals and health insurances by using the TeleCheck-AF approach preceding ECV in terms of cancelling unnecessary scheduled ECV appointments
|
through study completion, an average of 8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TeleConvert-AF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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