ChiCTR2500113564 版本V1.0 版本创建时间2025/12/01 10:08:38 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：

 ChiCTR2500113564 

最近更新日期：

Date of Last Refreshed on：

 2025-12-01 10:08:28 

注册时间：

Date of Registration：

 2025-12-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于“人工智能+MDT”的链式管理在全科老年患者中的应用研究

Public title：

Application of Chain Management Based on "Artificial Intelligence + MDT" in Elderly General Practice Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“人工智能+MDT”的链式管理在全科老年患者中的应用研究

Scientific title：

Application of Chain Management Based on "Artificial Intelligence + MDT" in Elderly General Practice Patients

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：

吴林雪 

研究负责人：

吴林雪 

Applicant：

?Linxue Wu? 

Study leader：

?Linxue Wu? 

申请注册联系人电话：

Applicant telephone：

 +86 151 6465 0295

研究负责人电话：

Study leader's
telephone：

+86 151 6465 0295

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：

 305739102@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 305739102@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：

黑龙江省齐齐哈尔市富拉尔基区向阳大街26号

研究负责人通讯地址：

黑龙江省齐齐哈尔市富拉尔基区向阳大街26号

Applicant address：

No. 26, Xiangyang Street, Fulaerji District, Qiqihar City, Heilongjiang Province, China??

Study leader's address：

No. 26, Xiangyang Street, Fulaerji District, Qiqihar City, Heilongjiang 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：

齐齐哈尔医学院附属第一医院

Applicant's institution：

The First Affiliated Hospital of Qiqihar Medical University

研究负责人所在单位：

齐齐哈尔医学院附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Qiqihar Medical University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 齐齐哈尔医学院附属第一医院(伦审)2025(研)第006号—001

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：

齐齐哈尔医学院附属第一医院伦理审查委员会?

Name of the ethic committee：

Ethics Review Committee of the First Affiliated Hospital of Qiqihar Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-12 00:00:00

伦理委员会联系人：

刘慧

Contact Name of the ethic committee：

Liu Hui

伦理委员会联系地址：

齐齐哈尔市富拉尔基区民生路1号

Contact Address of the ethic committee：

No. 1 Minsheng Road, Fularji District, Qiqihar City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 182 4927 0990

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：

齐齐哈尔医学院附属第一医院

Primary sponsor：

The First Affiliated Hospital of Qiqihar Medical University

研究实施负责（组长）单位地址：

黑龙江省齐齐哈尔市富拉尔基区向阳大街26号

Primary sponsor's address：

No. 26, Xiangyang Street, Fulaerji District, Qiqihar City, Heilongjiang 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)：

黑龙江省

市(区县)：

齐齐哈尔市

Country：

China

Province：

Heilongjiang Province

City：

Qiqihar City

单位(医院)：

齐齐哈尔医学院附属第一医院

具体地址：

黑龙江省齐齐哈尔市富拉尔基区向阳大街26号

Institution
hospital：

The First Affiliated Hospital of Qiqihar Medical University

Address：

No. 26, Xiangyang Street, Fulaerji District, Qiqihar City, Heilongjiang Province, China??

经费或物资来源：

自筹

Source(s) of funding：

Self-Funded

研究疾病：

老年肺感染  

Target disease：

Elderly patients with pulmonary infection

研究疾病代码：

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：

本研究旨在探讨基于“人工智能+MDT”的链式管理在老年肺部感染患者中的应用效果，通过提升护理质量和安全，切实改善老年患者的健康状况，提升康复效果，提高其自我管理能力及满意度。  

Objectives of Study：

The present study aims to evaluate the application effect of a chain management model based on "Artificial Intelligence + Multi-Disciplinary Team (MDT)" in elderly patients with pulmonary infections. By enhancing the quality and safety of care, this research seeks to tangibly improve the health status and rehabilitation outcomes of elderly patients, while also boosting their self-management capabilities and satisfaction.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄≥60岁，并存至少两种慢性疾病，且经临床明确诊断合并肺部感染的患者。 2.患者意识清楚，能够配合护理干预和调查研究。 3.患者或其家属签署知情同意书。

Inclusion criteria

1.Patients aged >= 60 years with at least two comorbid chronic diseases and clinically confirmed concurrent pulmonary infection. 2.patients who were conscious and able to cooperate with nursing interventions and the research investigation. 3.patients or their family members having provided signed informed consent.

排除标准：

1.患有严重精神疾病无法配合护理的患者。 2.患有终末期疾病预计生存期小于1个月患者。 3.已经接受过其他可能影响本研究结果的特殊护理干预的患者。

Exclusion criteria：

1.Patients with severe mental illness who are unable to cooperate with care. 2.Patients with terminal illnesses and a life expectancy of less than one month. 3.Patients who have previously received other specific nursing interventions that may influence the outcomes of this study.

研究实施时间：

Study execute time：

从 From 2025-11-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-10 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 80

Group：

Experimental Group

Sample size：

干预措施：

试验组在对照组基础上，采用“人工智能融合MDT康复护理模式”，该模式核心如下： 1. AI技术应用:通过智能设备、移动应用等渠道自动收集患者健康数据（生命体征、护理需求等），AI整合数据并生成动态更新的电子护理档案（含护理计划、健康评估、宣教内容），确保信息准确与隐私安全。责任护士借助317护网络平台、移动护理PDA、云智能随访系统等工具，为患者提供个体化康复指导（如运动、饮食、戒烟），并实现输液、给药等环节的精准核对与病情实时追踪，提升护理效率与安全性。 2. MDT团队组建与协作:团队涵盖医师、护士、心理咨询师、康复治疗师、营养师等多学科成员，由责任护士主导协调。住院阶段：制定个性化ERAS路径，联合评估后实施多学科干预；延续照护阶段：通过云随访系统（微信、短信、AI对话、电话）进行出院后7日内随访，收集满意度反馈，确保护理连续性。 3. 评估指标:对比干预前、后的临床症状（咳嗽、呼吸困难等）、辅助检查（血氧饱和度、肺CT、炎症指标等）、自我管理能力及满意度（问卷调查），并统计分析一般资料、康复效果等数据以评价干预成效。该模式通过AI与多学科协作的深度融合，旨在实现护理流程标准化、随访个性化及管理精准化。

干预措施代码：

Intervention：

The experimental group, building upon the standard care provided to the control group, received the "AI-Integrated MDT Rehabilitation Nursing Model." The core components of this model are as follows: 1. Application of AI Technology: AI technology automatically collects patient health data (e.g., vital signs, nursing needs) through intelligent devices and mobile applications. It integrates this data to generate a dynamically updated electronic nursing record, which includes nursing plans, health assessments, and patient education materials, ensuring information accuracy and privacy security. Responsible nurses utilize tools such as the "317 Hu" online platform, mobile nursing PDAs, and cloud-based intelligent follow-up systems to provide personalized rehabilitation guidance (e.g., exercise, diet, smoking cessation). This enables precise verification during procedures like intravenous infusion and medication administration, allows real-time tracking of patient conditions, and ultimately enhances nursing efficiency and safety . 2. MDT Team Formation and Collaboration: The team includes physicians, nurses, psychological consultants, rehabilitation therapists, nutritionists, and other multidisciplinary members, coordinated by a designated responsible nurse. During the hospitalization phase, a personalized ERAS (Enhanced Recovery After Surgery) pathway is developed, and joint assessments lead to implemented multidisciplinary interventions. In the continued care phase, a cloud follow-up system (utilizing WeChat, SMS, AI dialogue, and phone calls) conducts follow-ups within 7 days after discharge to collect satisfaction feedback and ensure care continuity . 3. Evaluation Indicators: A comparative analysis was conducted using data collected before and after the intervention. This included clinical symptoms (e.g., cough, dyspnea), auxiliary examinations (e.g., blood oxygen saturation, lung CT scans, inflammatory markers), self-management abilities, and satisfaction levels (assessed via questionnaires). General patient data, rehabilitation outcomes, and other relevant data were statistically analyzed to evaluate the intervention's effectiveness .This model achieves standardized nursing processes, personalized follow-up, and precise management through the deep integration of AI and multidisciplinary collaboration.

Intervention code：

组别：

对照组

样本量：

 80

Group：

Control Group

Sample size：

干预措施：

对照组采用常规护理干预，包括：常规病情观察（体温、脉搏、呼吸、血压、血氧饱和度、意识状态等）、遵医嘱准确给药、基础生活护理（口腔护理、皮肤护理、协助排痰等）及标准化健康教育（涵盖呼吸功能锻炼、营养支持、用药指导、心理疏导、饮食建议等内容）。出院时，向患者及家属告知出院流程、注意事项及复诊时间。

干预措施代码：

Intervention：

The control group received conventional nursing care, which included: routine monitoring of vital signs and condition (including temperature, pulse, respiration, blood pressure, blood oxygen saturation, and level of consciousness), accurate medication administration as prescribed by the physician, basic activities of daily living assistance (such as oral care, skin care, and assistance with sputum expulsion), and standardized health education (covering respiratory function exercises, nutritional support, medication guidance, psychological counseling, and dietary advice). Upon discharge, patients and their families were informed about the discharge procedures, necessary precautions, and follow-up appointment schedules.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江省 

市(区县)：

  

Country：

China

Province：

Heilongjiang Province

City：

单位(医院)：

 齐齐哈尔医学院附属第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Qiqihar Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

自我管理能力

指标类型：

主要指标

Outcome：

Self-management Skills

Type：

Primary indicator

测量时间点：

干预前、干预结束

测量方法：

采用Barthel指数评分量表进行评分

Measure time point of outcome：

Pre-intervention, end of intervention

Measure method：

Scores were evaluated using the Barthel Index Rating Scale.

指标中文名：

患者满意度

指标类型：

次要指标

Outcome：

Patient Satisfaction

Type：

Secondary indicator

测量时间点：

干预结束

测量方法：

采用医院自制的患者满意度调查问卷进行评分

Measure time point of outcome：

End of intervention

Measure method：

Scores were assessed via the hospital-developed Patient Satisfaction Questionnaire

指标中文名：

患者康复效果

指标类型：

次要指标

Outcome：

Patient Recovery Outcome

Type：

Secondary indicator

测量时间点：

干预前、干预结束

测量方法：

临床症状+辅助检查

Measure time point of outcome：

Pre-intervention, end of intervention

Measure method：

Clinical manifestations and auxiliary examination

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 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）：

由专业的统计人员使用统计学软件，按照设定的样本量要求，生成符合简单随机原则的随机数列。

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

Professional statisticians use statistical software to generate random number sequences that adhere to the principle of simple random sampling, following predetermined sample size requirements.

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

否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）：

研究公开发表后半年，邮件联系研究负责人合理获取。

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

Six months after the publication of the research, contact the research leader via email to obtain reasonable information.

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：

病例记录表

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-01 10:08:28