PROMBot-HSM-FA: Protocol for a Feasibility Study of a Chatbot-based Platform to Collect Patient-reported Outcomes After Atrial Fibrillation Ablation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 主要终点
- Retention Rate at 3 Months
研究概览
简要总结
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.
详细描述
The primary objective of this pilot study is to evaluate the feasibility and acceptability of integrating PROMBot-FA, a WhatsApp-based chatbot platform for collecting PROMs and clinical parameters, into routine post-ablation follow-up care at a tertiary hospital. Specific aims are to (1) assess recruitment, retention, and engagement rates during the first 3 months following AF ablation; (2) evaluate the acceptability and usability of the chatbot among patients and the clinical dashboard among healthcare professionals; and (3) explore preliminary effects on clinical outcomes, health-related quality of life, and integration into existing clinical workflows. This pilot trial will generate essential data for refining the intervention and designing a definitive effectiveness trial.
Methods Study Design This study is a single-center, parallel-group, randomized, open-label pilot trial. 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). Both groups will complete standardized baseline and 3-month follow-up assessments.
Ethical Considerations The study protocol was submitted to the Ethics Committee of Hospital de Santa Marta, Unidade Local de Saúde de São José (approval number pending). All participants will provide written informed consent before enrollment. The study will be conducted in accordance with the Declaration of Helsinki and complies with the European Union General Data Protection Regulation. Participants may withdraw from the study at any time without impact on their clinical care. Data will be pseudonymized and stored securely with access restricted to authorized study personnel.
This study is conducted within the scope of the CardioCausalAI project, funded by the Foundation for Science and Technology, Portugal (reference 2024.07369.IACDC), which develops causal artificial intelligence models for cardiovascular care.
Study Setting The study is conducted at the Department of Cardiology, Hospital de Santa Marta, Lisbon, Portugal. This tertiary referral center specializes in cardiothoracic care and performs a high volume of cardiac ablation procedures annually. Since 2011, the hospital has implemented a structured 1-year follow-up program involving periodic telephone consultations, creating a strong organizational foundation for digital health integration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Retention Rate at 3 Months
时间窗: 3 months post-ablation
Proportion of participants completing 3-month follow-up assessments among those initially enrolled.
Engagement rate
时间窗: 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.
次要结局
- 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)
研究者
Ana Rita Londral, PhD
PhD
Value for Health CoLAB