Effect of Non-Invasive Lung Fluid Monitoring for Heart Failure Management in Primary Care
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: ReDS-guided heart failure management program.
- Кому может быть актуально
- Состояния в реестре: Heart Failure. 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
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Non-Invasive Lung Fluid Monitoring Using ReDS Technology for Heart Failure Management in Primary Care Settings: A Randomized Controlled Trial
Обзор
Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. This randomized controlled trial aims to evaluate the effectiveness and processes of the ReDS-guided heart failure management program in primary care settings for patients with heart failure.
Подробное описание
Remote dielectric sensing (ReDS) technology offers a non-invasive method for assessing lung congestion. Our newly developed ReDS-guided heart failure management program, led by nurses, incorporates algorithms for a follow-up schedule, diuretic adjustments, and symptom monitoring.
The specific aims of the study are:
1. To examine whether the program decreases the number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death in patients with heart failure. 2. To evaluate the intervention processes and explore barriers to and facilitators for the implementation of the program.
This is a multicentre 1:1 randomised controlled clinical trial with a 6-month follow-up. Study participants will be patients with diagnosed with heart failure. The primary outcome will be the total number of urgent healthcare visits for heart failure, unplanned heart failure hospitalisation, and all-cause death at 3 months. Secondary outcomes will include health-related quality of life, self-care behaviour, and healthcare cost. Throughout the randomised controlled trial, a process evaluation will be conducted to assess the fidelity, dose, and reach of the intervention program. Additionally, we will explore both barriers and facilitators for program implementation among study patients and healthcare professionals.
Вмешательства
- Поведенческое ReDS-guided heart failure management program
Remote dielectric sensing (ReDS) system (Sensible Medical Innovations Ltd., Netanya, Israel) is a novel electromagnetic energy-based technology that accurately quantifies changes in lung fluid concentration non-invasively. Patients in the intervention group will receive a three-month, ReDS-guided heart failure management program in addition to usual care. The program, led by nurses, will integrate algorithms for diuretic use, a structured follow-up schedule, and self-care support tailored to p
Первичные конечные точки
- Total number of acute healthcare visits for heart failure, unplanned heart failure hospitalisations, and all-cause death [Срок оценки: 3 months]
Вторичные конечные точки (9)
- Total number of acute healthcare visits for heart failure [Срок оценки: 1 month, 3 months and 6 months]
- Total number of unplanned hospitalisations for heart failure [Срок оценки: 1 month, 3 months and 6 months]
- Total number of all-cause death [Срок оценки: 1 month, 3 months and 6 months]
- Number of days alive out of hospital [Срок оценки: 1 month, 3 months and 6 months]
- Changes in NT-proBNP/BNP levels [Срок оценки: Baseline, 3 months and 6 months]
- Changes in the remote dielectric sensing (ReDS) values [Срок оценки: Baseline, 3 months and 6 months]
- Changes in the 12-item Kansas City Cardiomyopathy Questionnaire scores [Срок оценки: Baseline, 1 month, 3 months and 6 months]
- Changes in the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) scores [Срок оценки: Baseline, 1 month, 3 months and 6 months]
- Changes in the heart failrue self-care behaviour scores [Срок оценки: Baseline, 1 month, 3 months and 6 months]
Критерии участия
Критерии включения
- Age ≥ 18 years, there is no upper age limit
- Diagnosed with heart failure regardless of left ventricular ejection fraction
- Having New York Heart Association (NYHA) Class III/IV irrespective of prior hospitalisation for heart failure, or NYHA II with a history of at least one hospitalisation for heart failure within the previous 12 months
- Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) within 12 months: (a) ≥450 pg/ml for patients under 50 years; (b) ≥900 pg/ml for patients aged 50-75 years; (c) ≥1800 pg/ml for patients over 75 years.
Критерии исключения
- NYHA I
- Life expectancy <6 months
- Physical characteristics that prevented use of the ReDS (body mass index < 22 or >39, and height less than 155 cm or higher than 195 cm)
- Implantation of a left ventricular assist device or cardiac transplantation.
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
- Поддерживающая терапия
Центры проведения
Швеция · 1 центр
- Primary care center Centrum Flen — Flen
Идентификаторы
NCT: NCT06734065 · Dnr 2024-05565-01