mHealth Rhythm Management in Terms of Cancelling Unnecessary Scheduled ECVs in Presumed Persistent AFpatients.
NCT ID: NCT06359132
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
264 participants
OBSERVATIONAL
2022-01-01
2025-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of an active implanted electronic cardiac device
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Viecuri Medical Center
Venlo, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TeleConvert-AF
Identifier Type: -
Identifier Source: org_study_id
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