ChiCTR2600117779 版本V1.0 版本创建时间2026/01/28 17:00:49 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600117779 

最近更新日期：

Date of Last Refreshed on：

2026-01-28 16:59:40 

注册时间：

Date of Registration：

2026-01-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

人机协同的AI个性化宣教对日间老年白内障术后患者健康教育效果的随机对照试验

Public title：

Randomized?Controlled Trial on the Effectiveness of Human-AI Collaborative Personalized Education for Ambulatory Elderly Patients After Cataract Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

人机协同的AI个性化宣教对日间老年白内障术后患者健康教育效果的随机对照试验

Scientific title：

Randomized?Controlled Trial on the Effectiveness of Human-AI Collaborative Personalized Education for Ambulatory Elderly Patients After Cataract Surgery

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

张博婵 

研究负责人：

喻娟 

Applicant：

Bochan Zhang 

Study leader：

Juan Yu 

申请注册联系人电话：

Applicant telephone：

+86 193 5460 1349

研究负责人电话：

Study leader's telephone：

+86 189 7116 3520

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

839548067@qq.com

研究负责人电子邮件：

Study leader's E-mail：

82338619@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

中国湖北省武汉市武珞路627号

研究负责人通讯地址：

中国湖北省武汉市武珞路627号

Applicant address：

No.627 Wuluo Road, Wuhan City, Hubei Province, China

Study leader's address：

No.627 Wuluo Road, Wuhan City, Hubei Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中国人民解放军中部战区总医院

Applicant's institution：

General hospital of central theater command

研究负责人所在单位：

中国人民解放军中部战区总医院

Affiliation of the Leader：

General hospital of central theater command

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

[2026]009-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中国人民解放军中部战区总医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of General Hospital of Central Theater Command

伦理委员会批准日期：

Date of approved by ethic committee：

2026-01-13 00:00:00

伦理委员会联系人：

朱忆洋

Contact Name of the ethic committee：

Yiyang Zhu

伦理委员会联系地址：

湖北省武汉市武珞路627号临床药学科

Contact Address of the ethic committee：

Department of Clinical Pharmacy, 627 Wuluo Road, Wuhan City, Hubei Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 27 5077 2992

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中国人民解放军中部战区总医院

Primary sponsor：

General hospital of central theater command

研究实施负责（组长）单位地址：

中国湖北省武汉市武珞路627号

Primary sponsor's address：

No.627 Wuluo Road, Wuhan City, Hubei Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北省

市(区县)：

武汉市

Country：

China

Province：

Hubei Province

City：

Wuhan

单位(医院)：

中国人民解放军中部战区总医院

具体地址：

湖北省武汉市武珞路627号

Institution
hospital：

General hospital of central theater command

Address：

No.627 Wuluo Road, Wuhan City, Hubei Province, China

经费或物资来源：

本研究为研究者发起的临床研究，无外部专项经费支持。研究所需的资源与成本（如人员时间、数据收集材料等）由研究者所在科室支持。

Source(s) of funding：

This study is a researcher-initiated clinical study, with no specific funding support . The resources and costs required for the study, such as personnel time and data collection materials, are supported by the department where the researchers are based.

Target disease：

Cataract

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

验证人机协同的AI个性化宣教模式能否有效促进患者对术后知识的理解与记忆，进而提升复查依从性、降低用药错误率，并评估其对患者满意度及护理工作流程的影响。  

Objectives of Study：

To verify whether the human-AI collaborative personalized education model can effectively enhance patients' understanding and memory of postoperative knowledge, thereby improving follow-up compliance and reducing medication error rates, and to assess its impact on patient satisfaction and nursing workflow.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

所有满足白内障相关诊断要求，其相关标准为WHO制定；年龄≥60岁；留院不超过24h；文化程度小学及以上，有智能手机，可独立操作微信；意识清楚，无严重听力、认知及精神障碍，能正常沟通；自愿参加本研究并签署知情同意书。

Inclusion criteria

All patients meeting the cataract-related diagnostic requirements, with the relevant criteria established by WHO; Age ≥ 60 years; Hospitalization duration not exceeding 24 hours; Education level of primary school or above, possessing a smartphone, and able to independently operate WeChat; Clear consciousness, without severe hearing, cognitive, or mental impairments, capable of normal communication; Voluntarily participating in this study and having signed informed consent.

排除标准：

合并严重心血管系统疾病；合并其他系统严重疾病及感染者；存在精神系统疾病或认知功能障碍，无法正常沟通者；无法使用智能手机或无人协助使用音频文件者；同步参与其他临床研究。

Exclusion criteria：

Patients with severe cardiovascular diseases;Patients with severe diseases of other systems or concurrent infections;Patients with psychiatric disorders or cognitive impairment unable to communicate effectively;Inability to use smartphones or lack of assistance for utilizing audio files;Concurrent participation in other clinical studies.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-02-01 00:00:00 至 To 2026-02-28 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

45

Group：

Control group

Sample size：

干预措施：

术后当日，对照组患者接受常规口头宣教、病房视频宣教。回访护士对患者进行术后知识口头问答，结果记录于《日间白内障术后健康教育知识掌握评估表》，随后指导患者完成《日间白内障术后健康教育评价》。术后第1日，对照组患者按常规流程复查。术后第3日，回访护士对患者进行电话随访，询问其过去3天内的用药错误情况。术后1周、1个月、3个月，回访护士通过医院信息系统查询并记录患者实际复查日期。在研究的全程，护士使用《患者重复咨询问题记录表》，记录患者就既定宣教内容发起重复咨询的频次。

干预措施代码：

Intervention：

On the day of surgery, patients in the control group received routine verbal health education and ward-based video health education.The follow-up nurse conducted a verbal knowledge assessment with the patient regarding postoperative care. The results were documented in the Ambulatory Cataract Surgery Postoperative Health Education Knowledge Mastery Assessment Form. Subsequently, the patient was instructed to complete the Ambulatory Cataract Surgery Postoperative Health Education Evaluation.On the first postoperative day,?patients in the control group underwent follow-up according to routine procedures.On postoperative day 3, the nurse conducted a telephone follow-up with the patient and inquired about medication errors in the past 3 days. At 1 week, 1 month, and 3 months after surgery, the follow-up nurse queries and records the patient's actual follow-up visit date via the hospital information system. Throughout the study period, nurses used the Patient Repeated Consultation Questions Record Form to document the frequency of patient-initiated repeated consultations regarding the pre-established educational content.

Intervention code：

组别：

试验组

样本量：

45

Group：

Experimental group

Sample size：

干预措施：

术后当日试验组由专岗护士依据流程生成《白内障术后当日安全与生活指导》的个性化文本初稿及匹配摘要，核验患者特征与匹配原因摘要（重点关注降级匹配是否符合场景化优先级原则），通过审核后将文稿转换为音频文件，试听无误再发送给患者及家属收听，并就关键内容进行沟通确认。回访护士对患者进行术后知识口头问答，结果记录于《日间白内障术后健康教育知识掌握评估表》，随后指导患者完成《日间白内障术后健康教育评价》。术后第1日试验组护士依据患者出院小结，输入患者特征、手术日期生成《白内障术后用药指导与复查提醒》文本初稿及匹配摘要，审核通过后转换为音频文件，试听无误再发给患者与家属。因本指导不涉及具体药物名称和剂量，必须向患者重点强调“具体用药请严格以出院小结和主管医生的交代为准”。术后第3日，回访护士对患者进行电话随访，询问其过去3天内的用药错误情况。术后1周、1个月、3个月，回访护士通过医院信息系统查询并记录患者实际复查日期。在研究的全程，护士使用《患者重复咨询问题记录表》，记录患者就既定宣教内容发起重复咨询的频次。

干预措施代码：

Intervention：

On the day of surgery, the designated-nurse in the experimental group generates a personalized draft text of the Safety and Life Guidance After Cataract Surgery and a matching rationale summary according to the established procedure. The nurse verifies the patient's characteristics against the matching rationale summary (paying particular attention to whether any downgraded matching complies with scenario-based priority rules). After passing the review, the document is converted into an audio file. Following a successful listening test, the audio file is sent to the patient and their family members for listening. Finally, the nurse communicates with the patient and family to confirm understanding of the key points.The results were documented in the Ambulatory Cataract Surgery Postoperative Health Education Knowledge Mastery Assessment Form. Subsequently, the patient was instructed to complete the Ambulatory Cataract Surgery Postoperative Health Education Evaluation. On the first postoperative day, nurses in the experimental group generated an initial draft of the Medication Guidance and Follow-up Reminder After Cataract Surgery text and a matching summary. This was done by inputting patient characteristics and the surgery date based on the patient's discharge summary. After review and approval, the text was converted into an audio file. The audio was carefully listened to for accuracy before being distributed to the patient and their family members. As this guidance does not include specific drug names or dosages, patients must be emphatically reminded that: "Specific medication use must rigorously adhere to the discharge summary and the instructions provided by the attending physician." On postoperative day 3, the nurse conducted a telephone follow-up with the patient and inquired about medication errors in the past 3 days. At 1 week, 1 month, and 3 months after surgery, the follow-up nurse queries and records the patient's actual follow-up visit date via the hospital information system. Throughout the study period, nurses used the Patient Repeated Consultation Questions Record Form to document the frequency of patient-initiated repeated consultations regarding the pre-established educational content.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

 武汉市 

Country：

China 

Province：

Hubei Province 

City：

Wuhan 

单位(医院)：

中国人民解放军中部战区总医院 

单位级别：

三级三甲 

Institution
hospital：

General hospital of central theater command

Level of the institution：

Grade A Level 3 Hospital

测量指标：

Outcomes：

指标中文名：

按时复查依从性

指标类型：

主要指标

Outcome：

Adherence to scheduled follow-ups

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

用药错误发生率

指标类型：

主要指标

Outcome：

Incidence of medication errors

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者健康知识掌握率

指标类型：

次要指标

Outcome：

Rate of patient health knowledge mastery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者健康教育评价

指标类型：

次要指标

Outcome：

Evaluation of patient health education

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

术后护理问题重复咨询频次

指标类型：

次要指标

Outcome：

Frequency of repeated consultations for postoperative care issues

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

护士对新宣教模式的评价

指标类型：

次要指标

Outcome：

Nurses' evaluation of new educational models

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究的随机序列由不参与受试者招募、干预实施及结局评估的独立统计人员，在研究开始前使用SPSS 26.0软件生成。采用完全随机化方法，为计划纳入的90例受试者按1：1的比例分配至试验组（人机协同宣教）与对照组（常规宣教）。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The random sequence for this study was generated before its commencement by an independent statistician, who was not involved in subject recruitment, intervention implementation, or outcome assessment, using SPSS version 26.0 software. The complete randomization method was used to allocate the planned 90 subjects in a 1:1 ratio to the experimental group (human-AI collaborative education) or the control group (routine education).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本研究设计为评估者盲（单盲）。由于干预措施的性质差异，无法对受试者及实施干预的责任护士设盲。但为最大限度地减少测量偏倚，对负责收集所有主要结局指标的专职回访护士实施了设盲，其在研究全程中不知晓受试者的分组信息。

Blinding：

This study was designed as an assessor-blinded (single-blind) trial. Due to the nature of the interventions, blinding of the subjects and the responsible nurses implementing the interventions was not possible. However, to minimize measurement bias, blinding was implemented for the dedicated follow-up nurses responsible for collecting all primary outcome measures; they remained unaware of the subjects’ group assignments throughout the study.

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

不共享。根据本研究方案及伦理审批，受试者的原始数据因隐私保护不予公开。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Data will not be shared. In accordance with the study protocol and ethical approval, the raw data from subjects will not be publicly disclosed to protect privacy.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本研究数据主要包括患者基本信息、研究过程指标及护士反馈数据。 1.数据采集：患者信息来源于医院信息系统（HIS）。通过面对面评估、电话回访、HIS查询及匿名问卷等方式，使用标准化表格收集知识掌握度、满意度、用药错误、复查依从性、重复咨询频次及护士体验等指标。 2.数据管理：所有纸质表采集后立即标记唯一研究编号，并由专人进行双人独立录入至密码保护的专用数据库。电子数据存储于加密移动硬盘，纸质数据存放于上锁文件柜，实行权限管理。分析使用去标识化数据集。使用的AI工具已关闭模型训练功能，生成音频后即清除在线记录。已制定针对数据泄露和系统故障的应急处理与报告流程。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: The data in this study primarily include patient basic information, study process indicators, and nurse feedback data. 1.Data Collection: Patient information was sourced from the Hospital Information System (HIS). Data on knowledge mastery, satisfaction, medication errors, review adherence, frequency of repeated consultations, and nurse experience were collected via face-to-face assessments, telephone follow-ups, HIS queries, and anonymous questionnaires using standardized forms. 2.Data Management: All data collected on paper forms were immediately labeled with a unique study identification number upon collection. Dedicated personnel performed double independent data entry into a password-protected database. Electronic data were stored on encrypted portable hard drives, while paper data were stored in locked filing cabinets, with access permission controls implemented. Analysis utilized de-identified datasets. The AI tools used had their model training capabilities disabled, and online records were cleared immediately after audio generation. Contingency procedures and reporting processes for data breaches and system failures have been established.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-28 16:59:40