AI-Personalized Discharge Education for Patients After Lung Cancer Surgery (AI-LUNG)
Effect of AI-Personalized Discharge Education on the Quality of Discharge Teaching and Recovery Outcomes in Patients After Lung Cancer Surgery: A Randomized Controlled Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
This is a single-center, prospective, single-blind randomized controlled trial designed to evaluate whether AI-personalized discharge education can improve discharge teaching quality and postoperative recovery outcomes among patients undergoing surgery for lung cancer. A total of 156 eligible participants will be randomly assigned in a 1:1 ratio to an intervention group or a control group.
Participants in the control group will receive routine discharge care, including verbal education provided by nursing staff and a standardized printed discharge education booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and other routine postoperative care.
Participants in the intervention group will receive routine discharge care plus AI-personalized discharge education. Within 24 hours before discharge, relevant patient information will be entered into a structured system, including surgical approach, extent of lung resection, pain score, dyspnea score, comorbidities, discharge medications, home care conditions, educational level, smoking history, and postoperative complications. A large language model will then generate an individualized discharge guidance document. The guidance will include medication instructions, respiratory rehabilitation exercises, wound and activity management, follow-up planning, and warning signs requiring medical attention. All AI-generated content will be reviewed and approved by a responsible nurse before being delivered to the participant or caregiver.
The primary outcome is discharge teaching quality, assessed using the Quality of Discharge Teaching Scale (QDTS) on the day of discharge after the intervention. Secondary outcomes include self-efficacy for postoperative rehabilitation management, assessed using the SESPRM-LC scale, and quality of life, assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) scale, both measured one month after discharge.
The study will also explore the relationships among discharge teaching quality, self-efficacy, and quality of life, including the potential mediating role of self-efficacy.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Weiguang Zhou, Master's
- Номер телефона: +86 13624449503
- Электронная почта: 254402969@qq.com
Места учебы
-
-
Jilin
-
Siping, Jilin, Китай, 136000
- Рекрутинг
- Siping Central People's Hospital
-
Главный следователь:
- Yang Liu, PhD
-
Контакт:
- Weiguang Zhou, Master's
- Номер телефона: +86 13624449503
- Электронная почта: 254402969@qq.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Pathologically confirmed primary lung cancer and underwent radical lung cancer surgery by thoracoscopic or open approach, including lobectomy, pneumonectomy, or wedge resection.
- Age 18 to 80 years.
- Clinical stage I to III.
- No distant organ metastasis.
- Clinically stable after surgery, conscious, and able to perform basic listening, speaking, and reading activities, with planned discharge to home for recovery.
- The participant or primary caregiver is able to use a smartphone and WeChat.
- Able and willing to provide informed consent and voluntarily participate in the study.
Exclusion Criteria:
- Recurrent lung cancer or previous treatment with targeted therapy, chemotherapy, or radiotherapy.
- Severe aphasia, cognitive impairment (MMSE <24), or psychiatric disorders that prevent independent completion of study questionnaires.
- Severe cardiac, hepatic, or renal dysfunction, or another malignant tumor.
- Severe postoperative complications requiring prolonged hospitalization, such as bronchopleural fistula or major bleeding.
- Participation in another interventional clinical study.
- Unable to complete the 1-month follow-up because of travel or residence outside the study area after discharge.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: AI-Personalized Discharge Education
Participants receive routine discharge education plus AI-personalized discharge guidance.
The personalized guidance is generated based on individual clinical and care-related information and is reviewed by a responsible nurse before being provided to the participant or caregiver.
|
Participants receive an individualized discharge guidance plan generated by an artificial intelligence system based on clinical and care-related information, including surgical approach, extent of lung resection, pain and dyspnea scores, comorbidities, discharge medications, home care conditions, educational level, smoking history, and postoperative complications.
The guidance includes medication instructions, respiratory exercises, wound and activity management, follow-up planning, and warning signs requiring medical attention.
All AI-generated content is reviewed by a responsible nurse before being provided to the participant or caregiver.
Participants receive routine discharge education provided by nursing staff, including verbal instructions and a standardized printed discharge booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and other routine postoperative care.
|
|
Активный компаратор: Routine Discharge Education
Participants receive routine discharge education, including verbal instructions from nursing staff and a standardized printed discharge education booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and related postoperative care.
|
Participants receive routine discharge education provided by nursing staff, including verbal instructions and a standardized printed discharge booklet covering medication use, wound care, respiratory exercises, physical activity, diet, follow-up, and other routine postoperative care.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quality of Discharge Teaching Scale (QDTS) Total Score
Временное ограничение: On the day of discharge, immediately after the intervention
|
Discharge teaching quality will be assessed using the Quality of Discharge Teaching Scale (QDTS).
The QDTS contains 24 items scored from 0 to 10, with a total score ranging from 0 to 240.
Higher scores indicate better quality of discharge teaching.
|
On the day of discharge, immediately after the intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Self-Efficacy for Postoperative Rehabilitation Management (SESPRM-LC) Total Score
Временное ограничение: 1 month after discharge
|
Self-efficacy for postoperative rehabilitation management will be assessed using the SESPRM-LC scale.
The scale contains 27 items scored from 1 to 5, with a total score ranging from 27 to 135.
Higher scores indicate greater self-efficacy.
|
1 month after discharge
|
|
Quality of Life Measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L)
Временное ограничение: 1 month after discharge
|
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L).
Higher scores indicate better quality of life.
|
1 month after discharge
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Yang Liu, PhD, Xiamen University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AI-LUNG-RCT-2026-01
- SKJT2026-003 (Другой идентификатор: Ethics Committee of Siping Central People's Hospital)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .