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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
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07498283
Acronym
EMPOWER-AF
Enrollment
290
Registered
2026-03-27
Start date
2026-05-26
Completion date
2028-11-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

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

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.

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.

Interventions

BEHAVIORALPeer-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.

Sponsors

University College Copenhagen
Lead SponsorOTHER
Herlev and Gentofte Hospital
CollaboratorOTHER
Nordsjaellands Hospital
CollaboratorOTHER
Hvidovre University Hospital
CollaboratorOTHER
Amager Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Due to the nature of the peer-mentor intervention, participants and mentors cannot be blinded to group allocation.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A)Baseline and 16 weeksAnxiety 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.

Secondary

MeasureTime frameDescription
Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)Baseline and 16 weeksDepressive symptoms are assessed using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D). The subscale consists of 7 items assessing mood, interest, and enjoyment, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater levels of depressive symptoms.
Atrial fibrillation-specific quality of life measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)Baseline and 16 weeksQuality of life is assessed using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. The questionnaire includes items assessing symptoms, daily activities, treatment concerns, and satisfaction over the past 4 weeks. Items are rated on a 7-point scale, and scores are transformed to a scale from 0 to 100, with higher scores indicating better quality of life.
Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease scale (SES6G)Baseline and 16 weeksSelf-efficacy is assessed using the Self-Efficacy for Managing Chronic Disease scale (SES6G), which includes 6 items assessing confidence in managing symptoms, emotional challenges, and daily activities related to chronic illness. Each item is scored on a scale from 1 to 10, and the total score is calculated as the mean of the items, with higher scores indicating greater self-efficacy.
Use of antidepressants and benzodiazepines based on redeemed prescriptionsFrom randomization to 24 weeks and 1 year follow-upUse of psychotropic medication is assessed using national prescription register data. This includes antidepressants (ATC code N06A) and benzodiazepines (ATC code N05B). The outcome is defined as the occurrence of at least one redeemed prescription during follow-up.Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.
Diagnoses of anxiety and depression based on hospital recordsFrom randomization to 24 weeks and 1 year follow-upDiagnoses of anxiety and depression are assessed using national patient register data. Diagnoses include anxiety disorders (ICD-10 code F41\*) and depressive disorders (ICD-10 codes F32-F33\*). The outcome is defined as the occurrence of at least one diagnosis during follow-up. Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.
Atrial fibrillation-related hospital contactsFrom randomization to 24 weeks and 1 year follow-upHospital contacts related to atrial fibrillation are assessed using national patient register data. Contacts are identified using ICD-10 code I48\* and include inpatient admissions and outpatient visits. The outcome is defined as the occurrence of at least one AF-related hospital contact during follow-up. Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.
Cardiac death and suicideFrom randomization to 24 weeks and 1 year follow-upMortality outcomes are assessed using national register data and include cardiac death and suicide during follow-up. The outcome is defined as the occurrence of death during the follow-up period. Outcome assessments are conducted at 24 weeks and 1 year after completion of the 16-week intervention.

Countries

Denmark

Contacts

CONTACTCecilie M L Mielow, MScNS
cecilie.mia.lykke.mielow.01@regionh.dk+4523474229
PRINCIPAL_INVESTIGATORSigne S Risom, Senior Researcher

Herlev and Gentofte Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026