Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation

NCT07498283 | Not Yet Recruiting

• 1 other identifier: F-26003029
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Peer mentor support; Mental well-being; Anxiety; Self-efficacy; Socioeconomic vulnerability; Atrial fibrillation; Cardiac patients

Outcome Measures

Primary Outcomes (1)

• Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A)

  Anxiety symptoms are assessed using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A). The subscale consists of 7 items assessing symptoms such as tension, worry, and panic, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater levels of anxiety symptoms.

  Baseline and 16 weeks

Secondary Outcomes (7)

• Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)

  Baseline and 16 weeks

• Atrial fibrillation-specific quality of life measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)

  Baseline and 16 weeks

• Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease scale (SES6G)

  Baseline and 16 weeks

• Use of antidepressants and benzodiazepines based on redeemed prescriptions

  From randomization to 24 weeks and 1 year follow-up

• Diagnoses of anxiety and depression based on hospital records

  From randomization to 24 weeks and 1 year follow-up

Study Arms (2)

Peer-Mentor Support + Usual Care

EXPERIMENTAL

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.

Behavioral: Peer-Mentor Support

Usual care

NO INTERVENTION

Participants randomized to this arm receive usual care according to local clinical practice for atrial fibrillation. No peer-mentor support is provided.

Interventions

Peer-Mentor Support BEHAVIORAL

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.

Peer-Mentor Support + Usual Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Herlev and Gentofte Hospital: collaborator
• University College Copenhagen: lead
• Nordsjaellands Hospital: collaborator
• Hvidovre University Hospital: collaborator
• Amager Hospital: collaborator

Study Sites (3)

Herlev and Gentofte Hospital

Herlev, Capital Region, 2730, Denmark

Location

Nordsjealland Hospital

Hillerød, Capital Region, 3400, Denmark

Location

Amager and Hvidovre Hospital

Hvidovre, Capital Region, 2650, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation; Psychological Well-Being; Anxiety Disorders

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Mental Disorders

Study Officials

• Signe S Risom, Senior Researcher

  Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilie M L Mielow, MScNS

CONTACT

+4523474229; cecilie.mia.lykke.mielow.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the peer-mentor intervention, participants and mentors cannot be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel-group randomized controlled trial comparing a peer-mentor intervention plus usual care with usual care alone.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

DK (3)