ChiCTR2600123383 版本V1.0 版本创建时间2026/04/26 17:40:59 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：

 ChiCTR2600123383 

最近更新日期：

Date of Last Refreshed on：

 2026-04-26 17:40:55 

注册时间：

Date of Registration：

 2026-04-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

COPD共病患者功能康复运动处方和自我护理智能化平台的构建与优化：基于知识图谱和网络分析

Public title：

Construction and optimisation of an intelligent platform for functional rehabilitation exercise prescription and self-care for co-morbid COPD patients: based on knowledge graph and network analysis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

COPD共病患者功能康复运动处方和自我护理智能化平台的构建与优化：基于知识图谱和网络分析

Scientific title：

Construction and optimisation of an intelligent platform for functional rehabilitation exercise prescription and self-care for co-morbid COPD patients: based on knowledge graph and network analysis

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：

刘勇, 李燚淼 

研究负责人：

王岚 

Applicant：

Yong LIU, Yimiao LI 

Study leader：

Lan WANG 

申请注册联系人电话：

Applicant telephone：

 +86 22 8333 6907

研究负责人电话：

Study leader's
telephone：

+86 22 8333 6907

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：

 LiYiMiao0802@tmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 wangl0423@tmu.edu.cn

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：

天津市和平区气象台路22号天津医科大学

研究负责人通讯地址：

天津市和平区气象台路22号天津医科大学

Applicant address：

Tianjin Medical University, 22 Meteorological Tai Road, Heping District, Tianjin

Study leader's address：

Tianjin Medical University, 22 Meteorological Tai Road, Heping District, Tianjin

申请注册联系人邮政编码：

Applicant postcode：

 300070

研究负责人邮政编码：

Study leader's postcode：

 300070

申请人所在单位：

天津医科大学

Applicant's institution：

Tianjin Medical University

研究负责人所在单位：

天津医科大学 天津市第四中心医院

Affiliation of the Leader：

Tianjin Medical University Tianjin No. 4 Central Hospital

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：

 TMUhMEC20240050

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：

天津医科大学医学伦理委员会

Name of the ethic committee：

the Ethics Committees of Tianjin Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-12 00:00:00

伦理委员会联系人：

王春梅

Contact Name of the ethic committee：

Chunmei Wang

伦理委员会联系地址：

天津市和平区气象台路22号天津医科大学

Contact Address of the ethic committee：

Tianjin Medical University, 22 Meteorological Tai Road, Heping District, Tianjin

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 22 8333 6900

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：

天津医科大学护理学院

Primary sponsor：

Tianjin Medical University School of Nursing

研究实施负责（组长）单位地址：

天津市和平区气象台路22号天津医科大学

Primary sponsor's address：

Tianjin Medical University, 22 Meteorological Tai Road, Heping District, Tianjin

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

天津

市(区县)：

天津

Country：

China

Province：

Tianjin

City：

Tianjin

单位(医院)：

天津市第四中心医院

具体地址：

天津市河北区中山路1号

Institution
hospital：

Tianjin Fourth Central Hospital

Address：

No.1 Zhongshan Road, Hebei District, Tianjin

经费或物资来源：

2024年天津市企业科技特派员项目立项：基于知识图谱的COPD肺康复运动处方智能平台的构建与优化，24YDTPJC00300，2024.10-2026.10，资助经费5万元。

Source(s) of funding：

2024 Tianjin Enterprise Science and Technology Specialist Project Project: Construction and Optimisation of an Intelligent Platform for COPD Pulmonary Rehabilitation Exercise Prescription Based on Knowledge Graph, 24YDTPJC00300, 2024.10-2026.10, with funding of 50,000 RMB.

研究疾病：

慢性阻塞性肺疾病  

Target disease：

chronic obstructive pulmonary disease (COPD)

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

我国慢阻肺患病现状亟待改善，由于COPD病程长、病情反复发作等特点，因COPD造成的急性加重、入院、死亡等不良事件给家庭、医疗系统造成了严重的经济社会负担，形势严峻，急需解决。鉴于COPD管理的长期性和复杂性与我国目前医疗资源分配不足的现状，依托现有医疗体系难以实现COPD长期有效控制，同时COPD患者中共病的发病率高达98.6%，且功能障碍水平相对较高。因此强调患者主动的自我护理是一种可持续性应对策略，亦是提高患者肺康复参与度是改善稳定期患者功能水平及生活质量的关键。本研究将人工智能和知识图谱等技术相融合，构建COPD患者功能康复运动处方和自我护理智能化应用平台，提高患者自我护理能力，改善患者生活质量，优化就医流程，获得广泛的社会效益。  

Objectives of Study：

The current status of chronic obstructive pulmonary disease (COPD) in China is in urgent need of improvement. Due to the long duration of COPD and recurrent exacerbations of COPD, acute exacerbations, hospital admissions, deaths and other adverse events caused by COPD have caused serious economic and social burdens on families and the healthcare system, and the situation is grim and needs to be addressed urgently. Given the long-term and complex nature of COPD management and the current situation of insufficient allocation of medical resources in China, it is difficult to achieve long-term effective control of COPD by relying on the existing healthcare system, while the prevalence of co-morbidities in patients with COPD is as high as 98.6% and the level of dysfunction is relatively high. Therefore, emphasising patient-initiated self-care is a sustainable coping strategy, and increasing patient participation in pulmonary rehabilitation is key to improving functional levels and quality of life in stable patients. In this study, artificial intelligence and knowledge graph technologies are integrated to build an intelligent application platform for functional rehabilitation exercise prescription and self-care for COPD patients, which improves patients' self-care ability and quality of life, optimises the medical treatment process, and achieves extensive social benefits.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

患者纳入标准： 1.符合《2024年GOLD慢性阻塞性肺疾病诊断、治疗及预防全球策略》中COPD诊断标准； 2.年龄>=18岁； 3.能够了解问卷每个条目所表达的含义，可自行完成或在调查员帮助下完成网络问卷调查； 4.知情同意且自愿参加； 5.生活完全能够自理； 6.可熟练应用智能手机、微信小程序。

Inclusion criteria

Patient inclusion criteria: 1.Meeting the diagnostic criteria for COPD in the GOLD Global Strategy for the Diagnosis, Treatment, and Prevention of Chronic Obstructive Pulmonary Disease 2024; 2.Aged >=18 years; 3.Able to understand the meaning expressed in each entry of the questionnaire, and able to complete the web-based questionnaire on their own or with the help of the investigator; 4.Informed consent and voluntary participation; 5.Fully able to take care of themselves; 6.Skilled in the application of smart phones and WeChat apps.

排除标准：

1.神志不清、精神异常者（如经医生诊断的精神疾病）； 2.合并肺癌及其他严重慢性疾病者（如合并骨骼肌病变、急性心肌梗死、视网膜脱落、恶性肿瘤、骨骼畸形、痛风等疾病）; 3.合并严重呼吸系统其他疾病如肺癌、肺结核、哮喘等。

Exclusion criteria：

1.Confusion, mental abnormality (such as mental illness diagnosed by a doctor); 2.Combined with lung cancer and other serious chronic diseases (such as combined with skeletal myopathy, acute myocardial infarction, retinal detachment, malignant neoplasm, bone deformity, gout and other diseases); 3.Combined with other serious respiratory system diseases such as lung cancer, tuberculosis, asthma, etc.

研究实施时间：

Study execute time：

从 From 2024-09-12 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-09-12 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 150

Group：

control subjects

Sample size：

干预措施：

给予常规健康宣教，告知参与者有任何疾病自我护理问题、以及症状感知、控制相关问题均可通过微信平台向干预团队成员进行咨询。

干预措施代码：

Intervention：

Routine health education was given, and participants were informed that they could consult members of the intervention team via the WeChat platform if they had any disease self-care questions, as well as questions related to symptom perception and control.

Intervention code：

组别：

试验组

样本量：

 150

Group：

test group

Sample size：

干预措施：

在常规健康宣教的基础上，通过基于微信小程序的问答系统实施干预。研究者本人帮助参与者搜索并登录该问答系统，在患者首次登录后帮助患者学习自我护理智能问答系统的使用，指导患者若有关于症状感知、控制、病情变化、自我护理知识等相关问题均可对智能问答系统进行提问，该智能问答系统会予以患者正确解答。在培训中，由研究者亲自演示该问答系统的使用方法，并由患者重复提问操作，以确保患者在居家遇到疾病相关疑问时可独立进行提问。研究人员鼓励患者在3个月干预期间每天都使用该问答系统，并由研究人员后台监督患者使用情况，对于使用率较低的患者及时展开提醒、随访。此外该系统会定期收集患者问题集，由人工审核后通过上传标准答案制定问答集，用于更新知识库，确保问答系统的迭代和更新。

干预措施代码：

Intervention：

On the basis of routine health education, the intervention was implemented through a question and answer system based on WeChat applets. The researcher helped participants to search for and log in to the Q&A system, and helped patients to learn how to use the self-care Q&A system after their first log-in, instructing them to ask questions about symptom perception, control, disease changes, self-care knowledge, etc., and the Q&A system would provide correct answers to the patients. During the training, the researcher demonstrated the use of the system and the patients repeated the questions to ensure that they could ask questions independently when they encountered disease-related problems at home. Patients were encouraged to use the Q&A system every day during the 3-month intervention period, and were monitored by the researcher in the background, with reminders and follow-up visits for patients with low usage rates. In addition, the system regularly collects patient question sets, which are manually reviewed and developed by uploading standardised answers for updating the knowledge base, ensuring that the Q&A system is iterative and up-to-date.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津 

市(区县)：

 天津 

Country：

China

Province：

Tianjin

City：

Tianjin

单位(医院)：

 天津市第四中心医院 

单位级别：

 三甲 

Institution
hospital：

Tianjin Fourth Central Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

慢性阻塞性肺疾病全球倡议

指标类型：

主要指标

Outcome：

Global Initiative for Chronic Obstructive Lung Disease

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

慢性阻塞性肺疾病评估测试

指标类型：

主要指标

Outcome：

Chronic Obstructive Pulmonary Disease Assessment Test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良英国医学研究委员会呼吸困难量表

指标类型：

主要指标

Outcome：

modified Medical Research Council,mMRC

Type：

Primary 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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 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）：

由未参与干预实施的研究组成员通过SPSS26.0生成随机数字表，预先定义将随机数队列按从小到大顺序排列，前50%进入试验组，其余进入对照组。将结果置于连续编号的不透明密闭信封中，以实现随机分配方案的隐藏。当研究对象符合纳排标准，签署知情同意书确定参加本研究后，由研究者按入组顺序拆开信封，对研究对象进行分组。

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

A table of random numbers was generated using SPSS 26.0 by a member of the study group who was not involved in the delivery of the intervention, and was pre-designed to order the random number cohorts from smallest to largest, with the top 50% going to the experimental group and the rest to the control group. The results were placed in sequentially numbered, opaque, airtight envelopes to conceal the random allocation scheme. Once the subjects met the eligibility criteria and signed the informed consent form confirming their participation in the study, the envelopes were opened by the investigator and the subjects were grouped in order of entry.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

评估者、数据分析者盲法

Blinding：

Blind method for evaluators and data analysts

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

邮箱：Ly0716@tmu.edu.cn 2026年6月30日以后

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

Email: Ly0716@tmu.edu.cn After June 30th, 2026

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：

研究者于医院呼吸科向符合纳排标准的参与者面对面介绍本研究的目标及大致内容并征得患者同意。患者同意后由研究员收集一般资料，了解患者疾病相关信息并教会患者使用该智能问答系统，将患者加入微信群以便后续追踪调查。预实验调查结束后（2周）收集患者历史问答记录并向患者发放微信干预评价表收集患者使用感受。 资料分析 收集系统中的患者历史问答记录后由研究人员进行人工审查，针对每条问题，由研究人员人工判定答案是否符合预期，计算准确率 Accuracy、召回率 Recall、精确率Precision、F1 值评价问答系统性能，研究人员根据微信干预评价表打分情况对该问答系统用户满意度进行评价。 质量控制 （1）预实验开始前：为保证患者平台使用依从性及发挥平台使用效果，在征得患者同意后由统一培训的调查员向患者介绍该平台如何使用，并确保患者已熟悉操作流程。 （2）预实验进行过程中：对患者疑问及自我护理行为提供解答和纠正问题的指导，对超过24小时未使用该平台的患者进行提醒，保证患者依从性。

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

The researcher introduced the objectives and general content of the study face-to-face in the respiratory department of the hospital to the participants who fulfilled the criteria for NAR and obtained the patients' consent. After the patient's consent was obtained, the researcher collected general information about the patient's disease and taught the patient how to use the smart Q&A system, and added the patient to the WeChat group for follow-up. At the end of the pre-test survey (2 weeks), the patients' history of Q&A records were collected and a WeChat intervention evaluation form was distributed to the patients to collect their feelings about using the system. Data analysis After collecting patients' historical Q&A records in the system, the researchers conducted manual review, and for each question, the researchers manually determined whether the answer met the expectation, calculated the Accuracy, Recall, Precision, and F1 values to evaluate the performance of the Q&A system, and evaluated the user satisfaction of the Q&A system based on the WeChat Intervention Evaluation Form scoring. Evaluation. Quality control (1) Before the pre-test began: in order to ensure patients‘ adherence to using the platform and to give full play to the effect of using the platform, a uniformly trained investigator introduced how to use the platform to the patients after obtaining the patients’ consent, and ensured that the patients were familiar with the operation process. (2) During the pre-test: Provide answers to patients' questions and self-care behaviours and guidance on correcting problems, and remind patients who have not used the platform for more than 24 hours to ensure patient compliance.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-04-26 17:40:55