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Supporto di Peer-Mentor per Pazienti Vulnerabili con Fibrillazione Atriale (EMPOWER-AF)

2 novembre 2026 aggiornato da: Cecilie Mia Lykke Mielow, University College Copenhagen

Esplorare e Migliorare il Benessere Mentale tra Pazienti Vulnerabili con Fibrillazione Atriale - Uno Studio Controllato Randomizzato su un Intervento di Mentoring tra Pari

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

290

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: Usual care

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A)
Lasso di tempo: Baseline and 16 weeks

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
Lasso di tempo: Baseline and 16 weeks

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.
Baseline and 16 weeks
Atrial fibrillation-specific quality of life measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT)
Lasso di tempo: Baseline and 16 weeks

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.
Baseline and 16 weeks
Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease scale (SES6G)
Lasso di tempo: Baseline and 16 weeks

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.
Baseline and 16 weeks
Use of antidepressants and benzodiazepines based on redeemed prescriptions
Lasso di tempo: From randomization to 24 weeks and 1 year follow-up

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.
From randomization to 24 weeks and 1 year follow-up
Diagnoses of anxiety and depression based on hospital records
Lasso di tempo: From randomization to 24 weeks and 1 year follow-up

Diagnoses 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.
From randomization to 24 weeks and 1 year follow-up
Atrial fibrillation-related hospital contacts
Lasso di tempo: From randomization to 24 weeks and 1 year follow-up

Hospital 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.
From randomization to 24 weeks and 1 year follow-up
Cardiac death and suicide
Lasso di tempo: From randomization to 24 weeks and 1 year follow-up

Mortality 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.
From randomization to 24 weeks and 1 year follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University College Copenhagen

Collaboratori

Hvidovre University Hospital
Amager Hospital
Herlev and Gentofte Hospital
Nordsjaellands Hospital

Investigatori

  • Investigatore principale: Signe S Risom, Senior Researcher, Herlev and Gentofte Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 maggio 2026

Completamento primario (Stimato)

1 novembre 2027

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

17 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 marzo 2026

Primo Inserito (Effettivo)

27 marzo 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • F-26003029

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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