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Remote atrial fibrillation management through teleconsultation vs. standard of care: The TeleCheck-AF randomised controlled trial.


Vanwege de COVID-19 pandemie is het momenteel niet wenselijk om stabiele patiënten met atriumfibrilleren fysiek op de polikliniek te zien. Om deze reden is in het MUMC+ een nieuwe mHealth infrastructuur ontwikkeld, die zorg op afstand middels app-gebaseerde hartslag- en ritmemonitoring voor patiënten met atriumfibrilleren via telefonische consulten mogelijk maakt: TeleCheck-AF. De effectiviteit en haalbaarheid van deze benadering is reeds bewezen, echter is de kosteneffectiviteit nog onzeker. Om deze reden is het doel van dit project, opgezet met diverse samenwerkingspartners, te onderzoeken of de TeleCheck-AF benadering net zo kosteneffectief is als de huidige standaardzorg. De verwachting is daarbij dat de TeleCheck-AF benadering resulteert in een betere kwaliteit van leven en lagere kosten, omdat (onnodige) bezoeken aan de polikliniek hiermee kunnen worden vermeden.


Samenvatting van de aanvraag

We are applying for a “stimuleringssubsidie“ to support our application process for the “DoelmatigheidsOnderzoek – Open ronde 2023: Onderzoek naar de effectiviteit en kosten.” The topic: A novel mobile health (mHealth) infrastructure to support teleconsultation: In the MUMC+, we developed a novel on-demand mHealth infrastructure to allow remote management of patients with atrial fibrillation (AF) through teleconsultation as an alternative to traditional face-to-face consultations: TeleCheck-AF. This approach incorporates three fundamental components: (1) a structured teleconsultation (“Tele”), (2) an app-based on-demand heart rate and rhythm monitoring infrastructure (“Check”) and (3) comprehensive AF management (“AF”). The effectiveness and feasibility of the TeleCheck-AF approach has been proven in the observational TeleCheck-AF project. However, the cost-effectiveness remains uncertain. We will set up an investigator-initiated prospective, randomized, open label, multicenter, non-inferiority trial with blinded endpoint evaluation. The randomized controlled trial (RCT) will be performed in 10 cardiology departments in The Netherlands. The hypothesis and endpoints: The TeleCheck-AF approach is non-inferior to the current standard care with respect to the primary endpoint that is a composite of: cardiovascular death; hospital admission for arrhythmias, heart failure, thromboembolic events, major bleeding, acute coronary syndrome or life-threatening effects of drugs; and arrhythmia related emergency department visits. Secondary endpoints are: patient satisfaction, quality of life and health care utilization all determined by validated questionnaires; number of contacts in both groups; the appropriate required change in therapy; indication for the unplanned in-between contacts and cost-effectiveness. This application focuses on improvement and optimization of care delivery to reduce costs in the future (Focus area of the DoelmatigheidsOnderzoek program). We are planning to show in a multicenter RCT that the TeleCheck-AF approach is non-inferior and cost-effective compared to standard of care with face-to-face consultation. The funding provided within the “stimuleringssubsidie“ will be used to allow a structured, informed and focused preparation of the application process. The following working packages (WP) will be supported: We are going to perform surveys to assess the new “standard of care” potentially impacted by COVID-19 restrictions (WP1). We will discuss with the ethics committee how to perform remote and online consent processes and follow-up appointments to reduce the burden for the outpatient clinics by face-to-face follow-up visits during possible coming COVID-19 restrictions (WP2). We are going to perform retrospective analysis of the observational TeleCheck-AF project to adapt the protocol and allow informed power-analysis of the proposed RCT (WP3). We are bringing together collaborators from several different disciplines. Meetings will be organized via Zoom to be compliant with potential upcoming COVID-19 restrictions. The early collaboration of the project group and the results derived from the WPs will facilitate the writing process and allow informed power calculation and approximation of the duration of the RCT improving the quality of the application. Additionally, the above-mentioned activities will result in common publications, which will positively impact the chances for a successful application process.


Looptijd: 100%
Looptijd: 100 %
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
J. Gulpen
Verantwoordelijke organisatie:
Maastricht University