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Набор скоро начнётся NCT06458829

Promoting Atrial Fibrillation Screening in Primary Care

Без фазы С лечением Atrial Fibrillation New Onset

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: SEARCH-AF.
Кому может быть актуально
Состояния в реестре: Atrial Fibrillation New Onset. Базовые параметры: от 65 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
Список центров уточняется — проверьте первичный протокол.
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

Effects of an Implementation Program to Promote Atrial Fibrillation Screening in Primary Care Centers in China

Обзор

Atrial fibrillation is the most common sustained cardiac arrhythmia in adults. Due to the asymptomatic and paroxysmal nature (randomly and shortly occurring of atrial fibrillation, and can therefore remain unnoticed) of atrial fibrillation. Atrial fibrillation increases the risk of stroke five fold if left untreated. Screening in old populations above age 65 years is helpful to find more atrial fibrillation cases. However, screening for atrial fibrillation is not well implemented in China. Thus, this project aims to promote atrial fibrillation screening in primary care centers in China. We will develop an intervention program (SEARCH-AF) and examine the effects (including the clinical effects and implementation effects) of program.

Подробное описание

Six health care centers in Guangzhou China will be included. We will adopt a stepped-wedge randomized trial design. Two health care centers will be randomly selected to receive the SEARCH-AF program at each step (a total of three steps).

The SEARCH-AF program will include opportunistic screening among those who aged 65 or above and screening promoting strategies. The A total of 4800 old adults will be screened for atrial fibrillation using a handheld single-lead ECG tool upon their visit to family doctor, with 800 for each health care center. The promoting strategy will be developed based on the Consolidated Framework for Implementation Research and include leadership engagement, policy support, providing screening resources, staff training on atrial fibrillation screening and management.

The whole study will last for 18 months. We will examine the intervention effects including clinical effects (atrial fibrillation detection rate, anticoagulation rate, atrial fibrillation related hospital visits, and stroke related end points) and implementation effects (cost-effectiveness of the intervention, compliance to atrial fibrillation screening ).

Вмешательства

  • Поведенческое SEARCH-AF
    SEARCH-AF program will include opportunistic screening among old adults during primary care visits and promoting strategies. Promoting strategies will be developed based on the Consolidated Framework for Implementation Research framework which may include leadership engagement, policy support, providing screening resources, atrial fibrillation screening and management training. General practitioner or nurse in each health care center will implement point-on-care screening. The intervention will

Первичные конечные точки

  • Atrial fibrillation detection rate [Срок оценки: End of the intervention (T0), three-month (T1) and six-month (T2) after the intervention.]
Вторичные конечные точки (5)
  • Anticoagulation rate [Срок оценки: Three-month and six-month post the intervention]
  • Cost-effectiveness [Срок оценки: Six-month post the intervention]
  • Atrial fibrillation associated events [Срок оценки: Three-month and six-month post the intervention]
  • Atrial fibrillation related medical resource consumption [Срок оценки: Three-month and six-month post the intervention]
  • Compliance with atrial fibrillation screening [Срок оценки: Three-month and six-month post the intervention]

Критерии участия

Критерии включения

  • aged 65 years or above
  • living in community

Критерии исключения

  • with a previous confirmed diagnosis of atrial fibrillation
  • with implanted ICD or pacemaker
  • unable to provide consent
  • involving in other atrial fibrillation screening program

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06458829 · Sunyatsenu

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗