System-integrated Technology-enabled Model of Care to Improve the Health of Stroke Patients With Dysphagia: a Cluster-randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 主要终点
- Aspiration pneumonia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
system-integrated technology-enabled model 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. The doctors in the system-integrated technology-enabled model group will receive systematic cascade training by specialists on clinical guidelines, essential medicines, nutritional management and behavior change.
干预措施: System-integrated Technology-enabled Model of Care (Behavioral)
control group
Control group will continue their routine practices without any intervention. No specific medical services will be provided for participants in the control group. Physicians will deliver clinical services including, but not limited to, scheduled follow-ups and prescription issuance based on patients' needs.
结局指标
主要结局
Aspiration pneumonia
时间窗: Up to day 365
Participants are monitored for the occurrence of aspiration pneumonia, with the standard being the diagnosis issued by the hospital. Participants or their relatives are required to regularly submit information regarding their pneumonia.
次要结局
- Nutrition Risk Screening 2002(day 0, day 181 and day 366)
- Dysphagia Outcome and Severity Scale(day 0, day 181 and day 366)
- Dysphagia Handicap Index(day 0, day 181 and day 366)
- Barthel Index(day 0, day 181 and day 366)
研究者
Zeng Xi
Principle Investigator
People's Hospital of Zhengzhou University