- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07827183
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Weiguang Zhou, Master's
- 전화번호: +86 13624449503
- 이메일: 254402969@qq.com
연구 장소
-
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Jilin
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Siping, Jilin, 중국, 136000
- 모병
- Siping Central People's Hospital
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수석 연구원:
- Yang Liu, PhD
-
연락하다:
- Weiguang Zhou, Master's
- 전화번호: +86 13624449503
- 이메일: 254402969@qq.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of Discharge Teaching Scale (QDTS) Total Score
기간: On the day of discharge, immediately after the intervention
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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.
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On the day of discharge, immediately after the intervention
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-Efficacy for Postoperative Rehabilitation Management (SESPRM-LC) Total Score
기간: 1 month after discharge
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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.
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1 month after discharge
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Quality of Life Measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L)
기간: 1 month after discharge
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Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L).
Higher scores indicate better quality of life.
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1 month after discharge
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Yang Liu, PhD, Xiamen University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- AI-LUNG-RCT-2026-01
- SKJT2026-003 (기타 식별자: Ethics Committee of Siping Central People's Hospital)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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