Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College Copenhagen
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Inability to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Peer-Mentor Support
BehavioralA 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.
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: Peer-Mentor Support + Usual CareExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline and 16 weeksSecondary outcomes
1
Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
Depressive 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.
Time frame
Baseline and 16 weeks2
Atrial fibrillation-specific quality of life measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
Quality 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.
Time frame
Baseline and 16 weeks3
Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease scale (SES6G)
Self-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.
Time frame
Baseline and 16 weeks4
Use of antidepressants and benzodiazepines based on redeemed prescriptions
Use 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.
Time frame
From randomization to 24 weeks and 1 year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University College Copenhagen
Lead sponsor
Herlev and Gentofte Hospital
Collaborator
Nordsjaellands Hospital
Collaborator
Hvidovre University Hospital
Collaborator
Amager Hospital
Collaborator
Source ClinicalTrials.gov