System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients With Dysphagia

Официальное название

System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients With Dysphagia: a Cluster-randomized Controlled Study

Обзор

The goal of this clinical trial is to explore the effects of the system-integrated technology-enabled model of care in ischemic stroke patients with dysphagia. The main question it aims to answer is: Can one-year system-integrated technology-enabled model of care improve the incidence of aspiration pneumonia, swallowing function, nutritional status, self-care ability, and quality of life among post-discharge ischemic stroke patients with dysphagia. Researchers will compare system-integrated technology-enabled model group and control group to see if there are significant intergroup differences in the incidence of aspiration pneumonia, swallowing function, nutritional status, self-care ability, and quality of life. Participants will be divided into the system-integrated technology-enabled model group and the control group. Participants in the system-integrated technology-enabled model group will receive support and follow-up services for dysphagia management, as well as physician-patient communication, with the assistance of mobile phones for one year. Participants in the control group will receive routine management.

Подробное описание

The goal of this clinical trial is to explore the effects of the system-integrated technology-enabled model of care in ischemic stroke patients with dysphagia. The main question it aims to answer is: Can one-year system-integrated technology-enabled model of care improve the incidence of aspiration pneumonia, swallowing function, nutritional status, self-care ability, and quality of life among post-discharge ischemic stroke patients with dysphagia.

Researchers will compare system-integrated technology-enabled model group and control group to see if there are significant intergroup differences in the incidence of aspiration pneumonia, swallowing function, nutritional status, self-care ability, and quality of life.

Participants will be divided into the system-integrated technology-enabled model group and the control group. Participants in the system-integrated technology-enabled model group will receive support and follow-up services for dysphagia management, as well as physician-patient communication, with the assistance of mobile phones for one year. Participants in the control group will receive routine management.

This study will last for one year per participant and the entire study will be conducted in China.

Вмешательства

• Поведенческое System-integrated Technology-enabled Model of Care
  The System-integrated Technology-enabled Model of Care includes the following components: enhanced monitoring and corresponding countermeasures for patients' daily diet, living habits and physical conditions via mobile devices; increased frequency of physician-patient communication; provision of dysphagia-related knowledge training and management guidance for county-level hospitals; delivery of swallowing-related health education to patients; and incentives. Doctors from trial site hospitals wi

Первичные конечные точки

• Aspiration pneumonia [Срок оценки: Up to day 365]

Вторичные конечные точки (4)

• Nutrition Risk Screening 2002 [Срок оценки: day 0, day 181 and day 366]
• Dysphagia Outcome and Severity Scale [Срок оценки: day 0, day 181 and day 366]
• Dysphagia Handicap Index [Срок оценки: day 0, day 181 and day 366]
• Barthel Index [Срок оценки: day 0, day 181 and day 366]

Критерии участия

Критерии включения

• discharged ischemic stroke survivors
• disease duration ≤3 months
• Dysphagia Outcome and Severity Scale grade ranging 1-5 levels.
• stable vital signs, out of the acute phase, and not requiring long-term bed rest and monitoring.
• reside locally for the next year.
• basic communication ability and offering informed consent.
• having and being able to use smart phones.
• free from aspiration pneumonia or its symptoms

Критерии исключения

• expected lifespan ≤1 year
• other severe systemic diseases.
• participating in other clinical trials.
• severe cognitive or psychiatric disorders, or severe aphasia.
• pregnant or lactating women.

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07563465 · SIMEI Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗