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临床试验/NCT07827183
NCT07827183招募中不适用

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

Xiamen University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2026年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
156
试验地点
1
主要终点
Quality of Discharge Teaching Scale (QDTS) Total Score

研究概览

简要总结

This randomized controlled trial evaluates the effect of artificial intelligence (AI)-personalized discharge education on discharge teaching quality and recovery outcomes in patients after lung cancer surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group. The control group will receive routine discharge education, including verbal instructions and a standardized printed discharge booklet. The intervention group will receive the same routine education plus an AI-generated personalized discharge guidance plan based on individual clinical and care-related information. All AI-generated content will be reviewed by a responsible nurse before being provided to participants. The primary outcome is the quality of discharge teaching measured on the day of discharge. Secondary outcomes include self-efficacy for postoperative rehabilitation management and quality of life assessed one month after discharge.

详细描述

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.

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)

盲法说明

Outcome assessors are blinded to group assignment. Due to the nature of the intervention, participants and nurses delivering the discharge education cannot be blinded. Data analysts will also remain unaware of group allocation during the primary analysis.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

AI-Personalized Discharge Education

Experimental

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.

干预措施: AI-Personalized Discharge Education (Behavioral)

AI-Personalized Discharge Education

Experimental

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.

干预措施: Routine Discharge Education (Behavioral)

Routine Discharge Education

Active Comparator

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.

干预措施: Routine Discharge Education (Behavioral)

结局指标

主要结局

Quality of Discharge Teaching Scale (QDTS) Total Score

时间窗: 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.

次要结局

  • Self-Efficacy for Postoperative Rehabilitation Management (SESPRM-LC) Total Score(1 month after discharge)
  • Quality of Life Measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L)(1 month after discharge)

研究者

发起方
Xiamen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xi Huang

Assistant Professor

Xiamen University

研究点 (1)

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