Поддержка равных-наставников для уязвимых пациентов с фибрилляцией предсердий (EMPOWER-AF)
Исследование и улучшение психического благополучия среди уязвимых пациентов с фибрилляцией предсердий - рандомизированное контролируемое исследование вмешательства с участием равных наставников
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Cecilie M L Mielow, MScN
- Номер телефона: +4523474229
- Электронная почта: cecilie.mia.lykke.mielow.01@regionh.dk
Места учебы
-
-
Capital Region
-
Herlev, Capital Region, Дания, 2730
- Рекрутинг
- Herlev and Gentofte Hospital
-
Главный следователь:
- Cecilie M L Mielow, MScNS
-
Контакт:
- Cecilie M L Mielow, MScN
- Номер телефона: +4523474229
- Электронная почта: cecilie.mia.lykke.mielow.01@regionh.dk
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Hillerød, Capital Region, Дания, 3400
- Рекрутинг
- Nordsjealland Hospital
-
Контакт:
- Maria K Pedersern, PhD
- Электронная почта: maria.kjoeller.pedersen@regionh.dk
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Контакт:
- Cecilie M L Mielow, MScNS
- Номер телефона: +4523474229
- Электронная почта: cecilie.mia.lykke.mielow.01@regionh.dk
-
Младший исследователь:
- Christina W Kamstrup, RN, BSN
-
Hvidovre, Capital Region, Дания, 2650
- Еще не набирают
- Amager and Hvidovre Hospital
-
Контакт:
- Cecilie M L Mielow, MScN
- Номер телефона: +4523474229
- Электронная почта: cecilie.mia.lykke.mielow.01@regionh.dk
-
Контакт:
- Stine M Rosenstroem, PhD
- Электронная почта: stine.maria.rosenstroem@regionh.dk
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
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. |
|
Без вмешательства: Usual care
Participants randomized to this arm receive usual care according to local clinical practice for atrial fibrillation. No peer-mentor support is provided. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Signe S Risom, Senior Researcher, Herlev and Gentofte Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- F-26003029
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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