NCT07498283

Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation

Explore and Improve Mental Well-being Among Vulnerable Patients With Atrial Fibrillation - A Randomized Controlled Trial of a Peer-Mentor Intervention

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 290 (estimated)
• Sponsor: University College Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life. These challenges are particularly pronounced among individuals with low socioeconomic position, who may face additional barriers to accessing supportive care. The main question the study aims to answer is: Does a 16-week peer-mentor intervention reduce anxiety symptoms among patients with AF compared with usual care? Researchers will compare peer-mentor support plus usual care with usual care alone. Participants will: Complete questionnaires about anxiety, depressive symptoms, quality of life, and self-efficacy at baseline and after 16 weeks. Be randomized either to receive peer-mentor support for 16 weeks or to receive usual care only. If allocated to the intervention group, be matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support and practical guidance through approximately eight contacts over the 16-week period. The study will also include follow-up using national health registers and a mixed-methods process evaluation exploring participants' and mentors' experiences with the intervention.

Detailed description

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and is associated with significant symptom burden, reduced quality of life, and high levels of psychological distress. Anxiety is particularly prevalent among patients with AF and may worsen symptom perception, increase health-related worry, and negatively affect engagement in self-management and healthcare. Individuals with low socioeconomic position often experience greater disease burden and face additional barriers to accessing supportive care, contributing to social inequalities in cardiovascular health. Peer support interventions have shown promising effects in other cardiac populations by providing emotional support, normalization of illness experiences, and practical guidance based on lived experience. Such interventions may enhance patients' confidence in managing their condition and navigating everyday life with chronic illness. The EMPOWER-AF study aims to evaluate the effectiveness of a peer-mentor intervention designed to support vulnerable patients with AF. The intervention is grounded in social cognitive theory, particularly the concept of self-efficacy, and is intended to strengthen patients' ability to manage symptoms, cope with uncertainty, and improve mental well-being. The study is conducted as a randomized controlled trial with two parallel groups. Participants are randomized to either a peer-mentor intervention in addition to usual care or usual care alone. The intervention lasts 16 weeks and involves one-to-one support between a trained peer mentor and a patient with AF. Peer mentors are individuals with lived experience of AF who have achieved stable everyday management of the condition and who are trained to provide emotional support and experiential guidance. Contacts between mentors and mentees may take place via telephone, face-to-face meetings, or digital communication depending on participant preferences. In addition to the randomized trial, the study includes an embedded mixed-methods process evaluation to explore participants' and mentors' experiences, mechanisms of impact, and contextual factors influencing engagement with the intervention. The study seeks to generate evidence on whether peer-based support can improve mental well-being among vulnerable patients with AF and contribute to more equitable and person-centered care for this patient group.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
BEHAVIORAL	Peer-Mentor Support	A 16-week peer-mentor program designed to support patients living with atrial fibrillation. Participants are matched with trained peer mentors who have lived experience with atrial fibrillation. Mentors provide emotional support, normalization of illness experiences, and practical non-clinical guidance for managing everyday life with the condition. Contacts between mentors and participants are planned approximately eight times during the intervention period and may take place via telephone, face-to-face meetings, or digital communication according to participant preferences. Mentors do not provide medical advice.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-11-01
• Completion: 2028-11-01
• First posted: 2026-03-27
• Last updated: 2026-04-02

Locations

3 sites across 1 country: Denmark