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Набор скоро начнётся NCT07628283

A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention and Management in Rural Elderly Adults in China

Без фазы С лечением Stroke Brain Ischemia Cerebral Hemorrhage Transient Ischemic Attack

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: Enhanced Usual Stroke Care, Digital Health Platform-Supported Integrated Stroke Management.
Кому может быть актуально
Состояния в реестре: Stroke, Brain Ischemia, Cerebral Hemorrhage, Transient Ischemic Attack. 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
Китай
Следующий шаг
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Официальное название

A Prospective, Open-Label, Cluster Randomized Controlled Trial to Evaluate the Efficacy of a Rural Doctor-Led, Telemedicine-Supported Integrated Care Model for Reducing Cardiovascular and Cerebrovascular Events in Elderly Adults at High Risk of Stroke in China

Обзор

This cluster randomized controlled trial aims to evaluate the effectiveness of a novel telemedicine-enabled integrated care model led by rural doctors in reducing cardiovascular and cerebrovascular events among elderly adults (≥65 years) at high risk of stroke in rural China. A total of 39 village clinics will be randomized to either the intervention group (digital health platform-supported integrated care) or the control group (enhanced usual care). The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for heart failure or acute coronary syndrome at 36 months.

Подробное описание

Stroke is the leading cause of death and disability in China, with a disproportionately higher burden in rural areas. This study proposes a "technology-enabled, vertically integrated, pathway-integrated, performance-incentivized" care model to address the gaps in rural stroke management. The intervention group will use a dedicated digital health platform (https://ricestroke.sqfh.org.cn:8421/gp/#/login) that provides clinical decision support, remote consultation with specialists, patient follow-up reminders, and performance feedback for rural doctors. The control group will receive enhanced usual care without the digital platform. The study will enroll 2510 participants and follow them for 36 months to assess the impact of the intervention on clinical outcomes, risk factor control, and medication adherence.

Вмешательства

  • Поведенческое Enhanced Usual Stroke Care
    Rural doctors provide monthly face-to-face care based on national guidelines, including symptom monitoring, blood pressure measurement, medication guidance, and patient education. Referrals to tertiary hospitals are made through conventional channels.
  • Поведенческое Digital Health Platform-Supported Integrated Stroke Management
    Patient electronic health record management AI-powered clinical decision support for medication adjustment based on Chinese stroke guidelines Weekly remote video consultation with neurologists from tertiary hospitals Automated follow-up and medication adherence reminders Structured education and training for both rural doctors and patients

Первичные конечные точки

  • Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months [Срок оценки: 36 months]
Вторичные конечные точки (6)
  • First Recurrent Stroke Event Rate at 36 Months [Срок оценки: 36 months]
  • All-Cause Mortality at 36 Months [Срок оценки: 36 months]
  • Cardiovascular-Specific Mortality at 36 Months [Срок оценки: 36 months]
  • Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months [Срок оценки: 36 months]
  • Major Bleeding Events (ISTH Criteria) at 36 Months [Срок оценки: 36 months]
  • Change in CHINA-PAR Score from Baseline to Month 12 [Срок оценки: Baseline, Month 12]

Критерии участия

Критерии включения

  • Aged 65 years or older
  • Rural residents with household registration or long-term residence (≥6 months/year) in the study area
  • High risk of stroke as defined by the National Health Commission's "8+2" stroke risk screening tool: ≥3 risk factors OR history of stroke/TIA
  • Willing to receive long-term health management from the assigned village clinic
  • Written informed consent provided by the participant or their legal representative

Критерии исключения

  • Severe dementia or psychiatric disorder that prevents completion of study follow-up and assessments
  • Life expectancy less than 1 year (e.g., advanced malignancy, end-stage renal disease)
  • Currently participating in another interventional clinical trial

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
Профилактика

Центры проведения

Китай · 1 центр
  • Suqian Hospital Affiliated to Jiangsu Provincial People's Hospital — Suqian

Публикации

  • Hao R, Qi X, Xia X, Wang L, Li X. Malnutrition on admission increases the in-hospital mortality and length of stay in elder adults with acute ischemic stroke. J Clin Lab Anal. 2022 Jan;36(1):e24132. doi: 10.1002/jcla.24132. Epub 2021 Dec 8. PMID 34877710

Идентификаторы

NCT: NCT07628283 · RICE-STROKE-2026-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗