Interventional Not yet recruiting
NCT07237178 on ClinicalTrials.gov
PROMBot-HSM-FA: Protocol for a Feasibility Study of a Chatbot Platform to Collect Patient-reported Outcomes After AF Ablation
Official title: PROMBot-HSM-FA: Protocol for a Feasibility Study of a Chatbot-based Platform to Collect Patient-reported Outcomes After Atrial Fibrillation Ablation
- Sponsor: Ana Rita Londral, PhD
- Enrollment: 76 (Estimated)
- Study start: 2025-12-01 (Estimated)
- Primary completion: 2026-04-01 (Estimated)
- Study completion: 2027-12-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Patients undergoing catheter ablation for AF will be randomly assigned in a 1:1 ratio to receive either chatbot-supported follow-up through the PROMBot-FA platform (intervention group) or standard care (control group).
- Masking: None
- PrimaryPurpose: Supportive Care
Brief Summary
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.
Conditions
- Atrial Fibrillation (AF)
- Catheter Ablation
Intervention / Treatment
- Behavioral: PROMBot-FA Chatbot-Supported Follow-Up
- Other: Standard Care (in control arm)
Primary Outcome Measures
-
Engagement rate
(3 months post-ablation)
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
(3 months post-ablation)
Proportion of participants completing 3-month follow-up assessments among those initially enrolled.
Study Officials
- Sérgio Laranjo, MD, PhD, PGDipHM, FESC, FACC (Principal Investigator) — Hospital de Santa Marta, ULS de São José