About this trial
The goal of this clinical trial is to learn if using a WhatsApp-based chatbot called PROMBot-FA can help people recover after atrial fibrillation ablation. The main questions it aims to answer are:
* Is the chatbot easy and practical for people to use after their procedure? * Do people find the chatbot helpful for sharing their symptoms and health updates?
Researchers will compare follow-up care supported by the chatbot to standard hospital follow-up visits. Participants will:
* Be randomly assigned to either use the chatbot or receive usual follow-up care. * Report their symptoms, well-being, and any problems after ablation for 3 months. * Complete short questionnaires about their experience using the chatbot.
This study will help researchers understand whether chatbot follow-up is feasible and acceptable for people after atrial fibrillation ablation and guide future larger studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 years or older;
documented diagnosis of paroxysmal or persistent AF based on clinical assessment and coded according to the International Classification of Diseases, 11th Revision;
undergone catheter ablation for AF at Hospital de Santa Marta during the study recruitment period;
able to use the PROMBot-FA chatbot independently or with caregiver assistance, defined as Portuguese literacy sufficient to understand instructions and ability to operate a smartphone;
Disqualifiers
severe cognitive impairment preventing comprehension of study procedures, such as moderate-to-severe dementia or other neurological conditions limiting capacity to consent;
severe uncorrected visual impairment or motor disability preventing smartphone operation even with caregiver support;
explicit refusal to use digital technology or unwillingness to share health data required for the study;
clinical or contextual conditions rendering 3-month follow-up unfeasible, including anticipated relocation outside the hospital catchment area or concurrent participation in another interventional study with overlapping endpoints; or
Trial design
Parallel
Treatments tested in this trial
PROMBot-FA Chatbot-Supported Follow-Up
BehavioralUse of the PROMBot-FA WhatsApp-based chatbot to collect patient-reported outcomes and clinical parameters during 3 months after ablation.
Standard Care (in control arm)
Other interventionRoutine follow-up according to institutional protocols without chatbot support.
Treatment groups
Trial outcomes
Primary outcomes
Engagement rate
Proportion of expected patient-reported outcomes and biosignal entries successfully collected through the chatbot platform over the 3-month monitoring period.
Retention Rate at 3 Months
Proportion of participants completing 3-month follow-up assessments among those initially enrolled.
Secondary outcomes
Post-Ablation Complications
Occurrence of complications including unplanned hospital readmission, emergency visit, thromboembolic event, major bleeding, cardiac tamponade, or death following AF ablation.
Atrial Fibrillation Recurrence Within 3 Months After Ablation
Recurrence of atrial fibrillation (AF) documented by ECG, Holter monitoring, or clinical records within 3 months after catheter ablation. Recurrence is defined as symptomatic relapse or the need for antiarrhythmic therapy, cardioversion, or repeat ablation.
Engagement Rate With Chatbot Prompts
Proportion of chatbot prompts answered by participants during the 3-month follow-up period, as recorded by system logs. Reflects user engagement and adherence to chatbot-supported monitoring.
System Usability Score (SUS)
Usability of the PROMBot-FA platform assessed using the System Usability Scale (SUS), a 10-item questionnaire producing a score from 0-100, with higher scores indicating better usability.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ana Rita Londral, PhD
Lead sponsor
Value for Health CoLAB
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: