PROMBot-HSM-FA: Protocol for a Feasibility Study of a Chatbot Platform to Collect Patient-reported Outcomes After AF Ablation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAna Rita Londral, PhD

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

Qualifiers

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

Treatments tested in this trial

  • PROMBot-FA Chatbot-Supported Follow-Up
  • Standard Care (in control arm)

Treatment groups

76 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Ana Rita Londral, PhD

Lead sponsor

Value for Health CoLAB

Sponsor institution