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Идёт набор NCT07498283

Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation

Без фазы С лечением Atrial Fibrillation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Peer-Mentor Support.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A) [Срок оценки: Baseline and 16 weeks]
Вторичные конечные точки (7)
  • Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D) [Срок оценки: Baseline and 16 weeks]
  • Atrial fibrillation-specific quality of life measured by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) [Срок оценки: Baseline and 16 weeks]
  • Self-efficacy measured by the Self-Efficacy for Managing Chronic Disease scale (SES6G) [Срок оценки: Baseline and 16 weeks]
  • Use of antidepressants and benzodiazepines based on redeemed prescriptions [Срок оценки: From randomization to 24 weeks and 1 year follow-up]
  • Diagnoses of anxiety and depression based on hospital records [Срок оценки: From randomization to 24 weeks and 1 year follow-up]
  • Atrial fibrillation-related hospital contacts [Срок оценки: From randomization to 24 weeks and 1 year follow-up]
  • Cardiac death and suicide [Срок оценки: From randomization to 24 weeks and 1 year follow-up]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Inability to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Дания · 3 центра
  • Herlev and Gentofte Hospital — Herlev
  • Nordsjealland Hospital — Hillerød
  • Amager and Hvidovre Hospital — Hvidovre

Идентификаторы

NCT: NCT07498283 · F-26003029

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗