Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359132
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-01-09
Brief Title:
mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-02
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:
TeleConvert-AF
Brief Summary:
Despite a clear definition in the European Society of Cardiology ESC guidelines the differentiation between paroxysmal self-terminating and persistent nonself- terminating atrial fibrillation AF remains challenging in clinical practice Some patients with presumed persistent AF are planned for electrical cardioversion ECV but appear to have a paroxysmal pattern or present in sinus rhythm SR at the scheduled ECV appointment This results in unnecessary visits or interventions for patients and costs and burden for the hospitals and health insurances Based on the feasibility of the TeleCheck-AF approach which is an on-demand mobile health mHealth infrastructure incorporating app-based heart rate and rhythm monitoring to support remote AF management through teleconsultation the investigators aim to extend this mHealth approach to the management of presumed persistent AF patients planned for ECV
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 phones 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 subjects 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 raterhythm 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 heshe 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 raterhythm 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 subjects 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
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 subjects 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 raterhythm 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 heshe 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 raterhythm 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 subjects 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 Oversight
Has Oversight DMC:
None
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?:
None