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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PROMBot-FA Chatbot-Supported Follow-Up

    Behavioral

    Use 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 intervention

    Routine follow-up according to institutional protocols without chatbot support.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Chatbot-Supported Follow-UpExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Engagement rate

Proportion of expected patient-reported outcomes and biosignal entries successfully collected through the chatbot platform over the 3-month monitoring period.

Time frame
3 months post-ablation
2

Retention Rate at 3 Months

Proportion of participants completing 3-month follow-up assessments among those initially enrolled.

Time frame
3 months post-ablation

Secondary outcomes

1

Post-Ablation Complications

Occurrence of complications including unplanned hospital readmission, emergency visit, thromboembolic event, major bleeding, cardiac tamponade, or death following AF ablation.

Time frame
Up to 12 months post-ablation
2

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.

Time frame
3 months post-ablation
3

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.

Time frame
3 months post-ablation
4

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.

Time frame
3 months post-ablation

Other outcomes

Locations

This trial has no 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: