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

NCT07237178 | Not Yet Recruiting

• 2 other identifiers: VOHCoLAB2024.07369.IACDC
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

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

Keywords

atrial fibrillation; catheter ablation; postoperative care; telemedicine; Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (2)

• Engagement rate

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

  3 months post-ablation

• Retention Rate at 3 Months

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

  3 months post-ablation

Secondary Outcomes (5)

• Post-Ablation Complications

  Up to 12 months post-ablation

• Atrial Fibrillation Recurrence Within 3 Months After Ablation

  3 months post-ablation

• Engagement Rate With Chatbot Prompts

  3 months post-ablation

• System Usability Score (SUS)

  3 months post-ablation

• Post-Study System Usability Questionnaire (PSSUQ) Score

  3 months post-ablation

Study Arms (2)

Chatbot-Supported Follow-Up

EXPERIMENTAL

Arm Type: Experimental Arm Name: Chatbot-Supported Follow-Up Description: Participants will use the PROMBot-FA WhatsApp chatbot to report symptoms and health information during the 3-month period after atrial fibrillation ablation. Intervention Name: PROMBot-FA Intervention Type: Behavioral Description of Intervention: A WhatsApp-based chatbot that collects patient-reported outcomes and clinical parameters after atrial fibrillation ablation.

Behavioral: PROMBot-FA Chatbot-Supported Follow-Up

Standard Care

ACTIVE COMPARATOR

Arm Type: Active Comparator Arm Name: Standard Follow-Up Description: Participants will receive standard post-ablation care, including scheduled clinic visits and standard communication methods. Intervention Name: Standard Post-Ablation Follow-Up Intervention Type: Usual Care Description of Intervention: Routine hospital follow-up according to institutional guidelines without chatbot interaction.

Other: Standard Care (in control arm)

Interventions

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.

Chatbot-Supported Follow-Up

Standard Care (in control arm) OTHER

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

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• clinically stable at discharge with no acute post-procedural complications precluding participation; and
• provision of written informed consent.

You may not qualify if:

• 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
• life expectancy less than 6 months.

Sponsors & Collaborators

• Ana Rita Londral, PhD: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sérgio Laranjo, MD, PhD, PGDipHM, FESC, FACC

  Hospital de Santa Marta, ULS de São José

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Londral, PhD

CONTACT

+351 963 428 661; ana.londral@vohcolab.org

Federico Guede, PhD

CONTACT

federico.guede@vohcolab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, it is not feasible to blind participants or healthcare professionals providing care. However, outcome assessors conducting medical record reviews for clinical endpoints (eg, hospitalizations, cardiovascular events) will be blinded to group allocation where possible. Statistical analyses will be conducted by a researcher blinded to group assignment until completion of primary analyses. Participants will be instructed not to disclose their group allocation during follow-up assessments conducted by blinded assessors.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: 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).

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11