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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults (≥18 years) with a confirmed diagnosis of atrial fibrillation

• Low socioeconomic position, primarily defined as educational attainment of vocational education or below

• Able to understand and speak Danish

• Able to provide written informed consent

• Able to complete study questionnaires

Locations
Other Locations
Denmark
Herlev and Gentofte Hospital
RECRUITING
Herlev
Nordsjealland Hospital
NOT_YET_RECRUITING
Hillerød
Amager and Hvidovre Hospital
NOT_YET_RECRUITING
Hvidovre
Contact Information
Primary
Cecilie M L Mielow, MScNS
cecilie.mia.lykke.mielow.01@regionh.dk
+4523474229
Time Frame
Start Date: 2026-05-26
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 290
Treatments
Experimental: Peer-Mentor Support + Usual Care
Participants randomized to this arm receive a 16-week peer-mentor intervention in addition to usual care. Each participant is matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support, normalization of illness experiences, and practical guidance. The intervention includes approximately eight contacts over 16 weeks delivered via telephone, face-to-face meetings, or digital communication depending on participant preferences. Participants continue to receive usual medical care throughout the study period.
No_intervention: Usual care
Participants randomized to this arm receive usual care according to local clinical practice for atrial fibrillation. No peer-mentor support is provided.
Related Therapeutic Areas
Sponsors
Leads: University College Copenhagen
Collaborators: Nordsjaellands Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital, Amager Hospital

This content was sourced from clinicaltrials.gov