ChiCTR2600125422 版本V1.0 版本创建时间2026/05/26 17:44:50 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：

 ChiCTR2600125422 

最近更新日期：

Date of Last Refreshed on：

 2026-05-26 17:43:55 

注册时间：

Date of Registration：

 2026-05-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

护士主导的综合护理模式对儿童支气管哮喘控制水平影响的前瞻性随机对照研究

Public title：

A Prospective Randomized Controlled Trial of a Nurse-Led Comprehensive Care Model for Improving Asthma Control in Children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

护士主导的综合护理模式对儿童支气管哮喘控制水平影响的前瞻性随机对照研究

Scientific title：

A Prospective Randomized Controlled Trial of a Nurse-Led Comprehensive Care Model for Improving Asthma Control in Children

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：

李秀杰 

研究负责人：

李秀杰 

Applicant：

Li Xiujie 

Study leader：

Li Xiujie 

申请注册联系人电话：

Applicant telephone：

 +86 188 4458 0795

研究负责人电话：

Study leader's
telephone：

+86 188 4458 0795

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：

 xiujie@jlu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 xiujie@jlu.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：

吉林省长春市朝阳区新民大街71号

研究负责人通讯地址：

吉林省长春市朝阳区新民大街71号

Applicant address：

No. 71 Xinmin Street, Chaoyang District, Changchun City, Jilin Province

Study leader's address：

No. 71 Xinmin Street, Chaoyang District, Changchun City, Jilin Province

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：

吉林大学第一医院

Applicant's institution：

The First Hospital of Jilin University

研究负责人所在单位：

吉林大学第一医院

Affiliation of the Leader：

The First Hospital of Jilin 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：

 26K148-001

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：

吉林大学第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Hospital of Jilin University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-24 00:00:00

伦理委员会联系人：

郭迪

Contact Name of the ethic committee：

Guo Di

伦理委员会联系地址：

吉林省长春市朝阳区新民大街71号

Contact Address of the ethic committee：

No. 71 Xinmin Street, Chaoyang District, Changchun City, Jilin Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 186 2879 2369

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：

吉林大学第一医院

Primary sponsor：

The First Hospital of Jilin University

研究实施负责（组长）单位地址：

吉林省长春市朝阳区新民大街71号

Primary sponsor's address：

No. 71 Xinmin Street, Chaoyang District, Changchun City, Jilin Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

吉林

市(区县)：

长春

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

吉林大学第一医院

具体地址：

吉林省长春市朝阳区新民大街71号

Institution
hospital：

The First Hospital of Jilin University

Address：

No. 71 Xinmin Street, Chaoyang District, Changchun City, Jilin Province

经费或物资来源：

吉林省医疗卫生人才专项（JLSWSRCZX2023-84）

Source(s) of funding：

The Project of Jilin Medical and Health Talents (No. JLSWSRCZX2023-84)

研究疾病：

支气管哮喘  

Target disease：

Pediatric asthma

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：

本研究的主要研究目的在于，通过前瞻性、随机对照的研究设计，系统评价护士主导的儿童哮喘综合护理模式在12个月随访期内对哮喘控制水平的影响。研究拟比较综合护理模式与常规护理模式在长期随访中的差异，重点关注综合护理干预是否能够在真实临床环境中显著改善儿童哮喘的整体控制状况，从而为儿童哮喘长期管理中护理模式的优化提供循证依据。 在此基础上，本研究还设定若干次要研究目的，以从多个维度全面评价综合护理模式的实际应用价值。次要研究目的包括评估护士主导综合护理模式在儿童哮喘管理中的可行性与安全性，观察随访过程中是否出现与护理干预相关的不良事件；比较综合护理模式与常规护理模式在随访期间哮喘急性加重、再就诊或再住院等临床结局方面的差异；同时，进一步分析综合护理干预对患儿及其家庭疾病管理行为、治疗依从性及随访依从性的影响。此外，本研究还拟探索不同年龄层患儿在综合护理干预下的反应特点，为后续制定更加精细化、分层化的儿童哮喘护理管理策略提供参考。  

Objectives of Study：

This study primarily aimed to systematically evaluate the effect of a nurse-led comprehensive pediatric asthma care model on asthma control during a 12-month follow-up period using a prospective randomized controlled design. The study intended to compare the differences between the comprehensive care model and routine care in long-term follow-up, with particular emphasis on whether the comprehensive nursing intervention could significantly improve overall asthma control in children under real-world clinical conditions. The findings are expected to provide evidence-based support for optimizing nursing care models in the long-term management of pediatric asthma. In addition, several secondary objectives were established to comprehensively assess the practical value of the comprehensive care model from multiple perspectives. These secondary objectives included evaluating the feasibility and safety of the nurse-led comprehensive nursing model in pediatric asthma management and monitoring whether any adverse events related to the nursing intervention occurred during follow-up. The study also aimed to compare the two care models with regard to clinical outcomes during follow-up, including asthma exacerbations, revisits, and rehospitalizations. Furthermore, the impact of the comprehensive nursing intervention on disease management behaviors, treatment adherence, and follow-up compliance among children and their caregivers was analyzed. Finally, this study sought to explore potential differences in responses to the intervention among children of different age groups, thereby providing a reference for developing more refined and stratified nursing management strategies for pediatric asthma in the future.

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. 本研究纳入对象为在研究期间于研究中心就诊的儿童支气管哮喘患儿。所有入选患儿年龄范围限定为 3–18 岁，性别不限，年龄的设定基于儿童哮喘诊断可靠性、量表评估适用性以及长期随访可行性等综合考虑。 2. 入选患儿须符合现行国内或国际公认的儿童支气管哮喘诊断标准，并由儿科呼吸专科医师明确诊断为支气管哮喘。研究对象可处于疾病稳定期，或为轻至中度急性发作经初步规范处理后病情已趋于稳定，能够接受护理干预并完成基线评估和后续随访。研究不因患儿既往或当前所接受的规范药物治疗而限制其入组，所有治疗方案均由临床医生根据指南和患儿病情决定。 3. 入选患儿及其监护人应具备完成研究随访的基本条件。监护人需具备基本沟通与理解能力，能够理解研究目的和流程，并配合完成研究期间的护理干预、随访评估及相关信息的提供。对于具备相应理解能力的学龄期儿童，在监护人同意的基础上，应能够配合完成相关评估内容。 4. 所有研究对象在入组前均需由研究人员向其监护人充分说明研究的目的、内容、可能的获益与风险以及受试者的权利和义务。监护人在充分理解并自愿同意的前提下签署书面知情同意书；对于具备认知和表达能力的适龄儿童，在监护人同意的基础上取得其同意或认可表达后，方可正式纳入研究。

Inclusion criteria

1. The study population consisted of children with bronchial asthma who attended the study center during the study period. Eligible participants were aged 3–18 years, with no restriction on sex. The age range was determined based on considerations including the reliability of asthma diagnosis in children, the applicability of assessment scales, and the feasibility of long-term follow-up; 2. Eligible participants were required to meet currently recognized national or international diagnostic criteria for pediatric bronchial asthma and to have a confirmed diagnosis made by a pediatric respiratory specialist. Participants could be in a stable phase of the disease or have mild-to-moderate acute exacerbations that had become clinically stable after initial standardized treatment, allowing them to receive the nursing intervention and complete baseline assessments and subsequent follow-up. Enrollment was not restricted by previous or ongoing standard pharmacological treatment, and all treatment regimens were determined by the treating physicians according to clinical guidelines and the individual patient’s condition; 3. Eligible participants and their guardians were required to have the basic capacity to complete study follow-up. Guardians needed to possess adequate communication and comprehension abilities to understand the study objectives and procedures and to cooperate with nursing interventions, follow-up assessments, and the provision of relevant information during the study period. School-aged children with sufficient cognitive and communication abilities were also required, with guardian consent, to cooperate in completing the relevant assessments; 4. Before enrollment, investigators fully explained the study objectives, procedures, potential benefits and risks, as well as the rights and obligations of participants to the guardians of all eligible children. Written informed consent was obtained voluntarily from guardians after full understanding of the study. For age-appropriate children with sufficient cognitive and expressive abilities, assent or affirmative agreement was additionally obtained on the basis of guardian consent before formal enrollment in the study.

排除标准：

符合以下任一情况的受试者将被排除在本研究之外： 1.合并严重基础疾病者，包括但不限于严重先天性心脏病、慢性肾功能不全、严重肝功能障碍、免疫缺陷病、恶性肿瘤或其他影响生存预后的系统性疾病。 2.合并严重神经系统或精神系统疾病，影响认知功能或依从性，无法配合护理干预及随访评估者。 3.合并其他慢性呼吸系统疾病（如囊性纤维化、支气管扩张症、原发性纤毛运动障碍等），可能干扰研究结局判断者。 4.住院期间病情危重，需进入重症监护病房（PICU）持续治疗，或需要机械通气支持时间较长者。 5.既往已接受系统化、长期的综合护理或专科慢病管理干预，可能影响研究干预效果评估者。 6.研究期间计划转院或预计无法完成随访者。 7.监护人拒绝签署知情同意书，或在研究开始前撤回同意者。

Exclusion criteria：

Participants meeting any of the following criteria were excluded from the study: 1. Children with severe underlying diseases, including but not limited to severe congenital heart disease, chronic renal insufficiency, severe hepatic dysfunction, immunodeficiency disorders, malignant tumors, or other systemic diseases that could affect survival prognosis; 2. Children with severe neurological or psychiatric disorders that could impair cognitive function or treatment compliance and therefore interfere with participation in the nursing intervention or follow-up assessments; 3. Children with other chronic respiratory diseases, such as cystic fibrosis, bronchiectasis, or primary ciliary dyskinesia, which might confound the assessment of study outcomes; 4. Children in critical condition during hospitalization who required continuous treatment in the Pediatric Intensive Care Unit (PICU) or prolonged mechanical ventilatory support; 5. Children who had previously received systematic and long-term comprehensive nursing care or specialized chronic disease management interventions that might influence the evaluation of the study intervention effects; 6. Children who planned to transfer to another hospital during the study period or were expected to be unable to complete follow-up assessments; 7. Children whose guardians refused to sign the written informed consent form or withdrew consent before study initiation.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2028-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 60

Group：

Intervention group

Sample size：

干预措施：

护士主导儿童哮喘综合管理模式

干预措施代码：

Intervention：

Nurse-led comprehensive asthma management program

Intervention code：

组别：

对照组

样本量：

 60

Group：

Control group

Sample size：

干预措施：

常规门诊护理

干预措施代码：

Intervention：

Routine outpatient care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 吉林 

市(区县)：

 长春 

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

 吉林大学第一医院 

单位级别：

 三级 

Institution
hospital：

The First Hospital of Jilin University

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

儿童哮喘控制水平

指标类型：

主要指标

Outcome：

Asthma control level

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

哮喘自我管理能力

指标类型：

次要指标

Outcome：

Asthma self-management ability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

用药依从性

指标类型：

次要指标

Outcome：

Medication compliance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

吸入装置操作规范性

指标类型：

次要指标

Outcome：

Operating norms for inhalation devices

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

哮喘相关生活质量

指标类型：

次要指标

Outcome：

Quality of life related to asthma

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 3 岁 years
最大 Max age 18 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）：

本研究采用计算机随机数字表法进行随机分组。随机序列由未参与受试者招募、干预实施及结局评估的独立研究人员使用SPSS软件生成。符合纳入标准的受试者按照1:1比例随机分配至干预组和对照组。

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

Randomization was performed using a computer-generated random number sequence. The random allocation sequence was generated by an independent researcher who was not involved in participant recruitment, intervention implementation, or outcome assessment using SPSS software. Eligible participants were randomly assigned to the intervention group or control group at a 1:1 ratio.

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：

由于护理干预措施的特殊性，本研究未对受试者及护理人员实施盲法。但结局评估及统计分析由未参与干预实施的研究人员完成，以减少观察偏倚。

Blinding：

Due to the nature of the nursing intervention, blinding of participants and nursing staff was not feasible in this study. However, outcome assessment and statistical analysis were performed by researchers who were not involved in the intervention implementation to minimize assessment bias.

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）：

无

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

None

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, CRF

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：

  2026-05-26 17:43:55