REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia (RESEARCH-Pneumonia)
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: TCM.
- Кому может быть актуально
- Состояния в реестре: Pneumonia. Базовые параметры: 18 лет — 85 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.
Подробное описание
The incidence, hospitalization rate, and mortality associated with pneumonia are significant, contributing to a substantial disease burden. Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient, leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications. In clinical practice, there is a predominant focus on the amelioration of clinical symptoms during hospitalization, with limited attention to ongoing outpatient interventions aimed at reducing readmission rates. Consequently, there is a pressing need for cohort studies on pneumonia.
This study is a multicenter, prospective cohort study involving adult patients discharged after pneumonia treatment. Approximately 5,000 patients will be enrolled, with follow-up assessments conducted every three months over the course of one year. After one year, patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine (TCM) treatment received (e.g., continuous treatment for two months or intermittent treatment for three months per year). One cohort will consist of patients receiving TCM, while the other will include those who did not receive TCM. The primary endpoint is the rate of hospital readmission, while secondary outcomes include treatment satisfaction, physician-reported outcomes, patient-reported outcomes, quality of life, nutritional status, incidence of acute upper respiratory tract infections, and survival. This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge.
Вмешательства
- Препарат TCM
We will perform subgroup analyses based on specific TCM interventions (such as Chinese patent medicines or external therapies) and the duration of TCM treatment (for example, comparing patients who receive continuous oral Chinese patent medicine for two months or more each year with those who do not). These analyses will assess the efficacy and safety of TCM.
Первичные конечные точки
- Rehospitalization rate [Срок оценки: The Rehospitalization rate within a one-year follow-up period]
Вторичные конечные точки (7)
- Patient satisfaction with efficacy [Срок оценки: Changes in ESQ-COPD relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- Health survey summary table（SF-36） [Срок оценки: Changes in SF-36 relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- Clinical outcomes reported by patients [Срок оценки: Changes in CAP-PRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- Clinical outcomes reported by doctors [Срок оценки: Changes in CAP-CRO relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
- nutritional status [Срок оценки: Changes in nutritional status of CAP patients relative to baseline at 6 and 12 months of follow-up stage]
- Acute upper respiratory tract infection (URTI) event [Срок оценки: Acute upper respiratory tract infection events that occurred during the one-year follow-up period]
- Survival situation [Срок оценки: Changes in patient survival situation relative to baseline at months 3, 6, 9, and 12 during the follow-up phase]
Критерии участия
Selection Criteria:
- Hospitalized patients with a confirmed diagnosis of pneumonia (HAP, CAP).
- Age ≥18 years.
- Signed informed consent form.
Критерии исключения
- Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
- Patients with altered mental status, dementia, consciousness disorders, or various psychiatric conditions;
- Those who are completely unable to care for themselves or are bedridden long-term; and those currently participating in other clinical drug trials.
- Known to be allergic to treatment drugs.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06220019 · RESEARCH-Pneumonia