ChiCTR2600119607 版本V1.0 版本创建时间2026/02/28 17:51:30 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：

 ChiCTR2600119607 

最近更新日期：

Date of Last Refreshed on：

 2026-02-28 17:51:26 

注册时间：

Date of Registration：

 2026-02-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于二元动态交互模型的慢性阻塞性肺疾病患者与照护者健康素养协同促进方案的构建与应用

Public title：

Construction and Application of a Synergistic Promotion Program for Health Literacy of Patients with Chronic Obstructive Pulmonary Disease and Their Caregivers Based on the Binary Dynamic Interaction Model

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于二元动态交互模型的慢性阻塞性肺疾病患者与照护者健康素养协同促进方案的构建与应用

Scientific title：

Construction and Application of a Synergistic Promotion Program for Health Literacy of Patients with Chronic Obstructive Pulmonary Disease and Their Caregivers Based on the Binary Dynamic Interaction Model

研究课题代号(代码)：

Study subject ID：

 2025141

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：

吕海鹏 

研究负责人：

吕海鹏 

Applicant：

Lv Haipeng 

Study leader：

Lv Haipeng 

申请注册联系人电话：

Applicant telephone：

 +86 134 2792 5346

研究负责人电话：

Study leader's
telephone：

+86 134 2792 5346

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：

 lvhaipeng8888@163.com

研究负责人电子邮件：

Study leader's E-mail：

 lvhaipeng8888@163.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：

广东省深圳市福田区北环大道6001号

研究负责人通讯地址：

广东省深圳市福田区北环大道6001号

Applicant address：

No. 6001, Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

Study leader's address：

No. 6001, Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

申请注册联系人邮政编码：

Applicant postcode：

 518114

研究负责人邮政编码：

Study leader's postcode：

 518114

申请人所在单位：

广州中医药大学深圳医院(福田)

Applicant's institution：

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

研究负责人所在单位：

广州中医药大学深圳医院(福田)

Affiliation of the Leader：

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

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：

 GZYLL(KY)-2025-058

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：

广州中医药大学深圳医院(福田)医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-19 00:00:00

伦理委员会联系人：

卢琳

Contact Name of the ethic committee：

Lv Ling

伦理委员会联系地址：

广东省深圳市福田区北环大道6001号

Contact Address of the ethic committee：

No. 6001, Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 755 8354 8506

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gzyszyyll@126.com

研究实施负责（组长）单位：

广州中医药大学深圳医院(福田)

Primary sponsor：

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

研究实施负责（组长）单位地址：

广东省深圳市福田区北环大道6001号

Primary sponsor's address：

No. 6001, Beihuan Avenue, Futian District, Shenzhen City, Guangdong 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)：

广东省

市(区县)：

深圳市

Country：

China

Province：

Guangdong Province

City：

Shenzhen City

单位(医院)：

广州中医药大学深圳医院(福田)

具体地址：

广东省深圳市福田区北环大道6001号

Institution
hospital：

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

Address：

No. 6001, Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

经费或物资来源：

自筹经费

Source(s) of funding：

self-funded project

研究疾病：

慢性阻塞性肺疾病  

Target disease：

Chronic Obstructive Pulmonary Disease

研究疾病代码：

COPD

Target disease code：

COPD

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：

研究目的 （1）分析COPD患者及其照护者健康素养的现状及影响因素。 （2）构建基于二元动态交互模型的健康素养协同促进方案。 （3）评估该方案在提高患者和照护者健康素养、改善患者康复效果方面的应用价值。  

Objectives of Study：

(1) To analyze the current status and influencing factors of health literacy among COPD patients and their caregivers. (2) To develop a collaborative health literacy promotion program based on the Dyadic Interplay Model. (3) To evaluate the application value of this program in improving health literacy of patients and caregivers, and enhancing patient rehabilitation outcomes.

药物成份或治疗方案详述：

“二元动态交互模型”为基础，初步拟定COPD患者及照顾者健康素养协同促进方案初稿。便利选取某三级甲等综合性医院267名COPD患者及家属进行半结构化访谈，并于0、1、3、6个月分别进行纵向研究，完善方案初稿。并采用德尔菲专家函询法进行专家函询。根据函询结果，经小组讨论对方案进行修改补充，最终形成基于二元动态模型COPD患者及照顾者健康素养协同促进方案。通过专家积极系数、专家权威系数和肯德尔协调系数判断函询结果的可靠性。随机区组设计随机对照应用该方案，验证方案对提升健康素养及改善肺康复状况的应用价值，促进高效经济的COPD患者疾病管理，为减轻疾病照护负担提供科学依据和实践指导。 

Description for medicine or protocol of treatment in detail：

Based on the "Dyadic Dynamic Interaction Model," we propose a draft collaborative health literacy promotion program for COPD patients and their caregivers. This study aims to refine this preliminary program through empirical research and expert consultation, ultimately conducting a randomized controlled trial to validate its efficacy. Phase 1: Program Development and Refinement We will recruit 267 COPD patients and their family caregivers through convenience sampling from a tertiary Grade-A general hospital. Semi-structured interviews will be conducted, followed by longitudinal assessments at baseline (0 month), 1 month, 3 months, and 6 months to iteratively refine the preliminary program draft. Phase 2: Expert Consultation The Delphi method will be employed for expert consultation. Based on the consultation feedback, the research team will modify and supplement the program through group discussions, ultimately finalizing the "Collaborative Health Literacy Promotion Program for COPD Patients and Caregivers Based on the Dyadic Dynamic Model." The reliability of the consultation results will be evaluated through expert response rate (active coefficient), expert authority coefficient, and Kendall's coefficient of concordance. Phase 3: Implementation and Validation A randomized block design randomized controlled trial (RCT) will be conducted to apply the finalized program. This trial aims to validate the program's practical value in improving health literacy and enhancing pulmonary rehabilitation status, thereby promoting efficient and economical disease management for COPD patients and providing scientific evidence and practical guidance for reducing the burden of disease care. 

纳入标准：

COPD患者纳入标准： （1）根据COPD诊治指南（2021 年修订版）[65]确诊的COPD患者，即吸入支气管舒张剂后第一秒用力呼气容积（Forced Expiratory Volume in the FirstSecond ，FEV1）/用力肺活量（Forced Vital Capacity，FVC）<70%；同时伴有呼吸困难、咳嗽和（或）咳痰症状的急性变化，且这些变化超出日常的变异范围。 （2）年满 18 周岁，由家属作为主要照顾者。 （3）具有一定的沟通、表达和理解能力。 （4）自愿参加本研究，并签署知情同意书。 COPD患者照顾者纳入标准： （1）认知功能正常，能正确理解问卷内容的配偶照顾者； （2）年满 18 周岁； （3）承担患者主要照顾任务，按照文献[66]照顾者定义要求，照顾时间≥4小时/天，累计照顾天数为90 天及以上； （4）自愿参加本研究，并签署知情同意书。

Inclusion criteria

Inclusion Criteria for COPD Patients: 1. Patients diagnosed with COPD according to the COPD Diagnosis and Treatment Guidelines (2021 Revised Edition) [65], specifically those with a post-bronchodilator Forced Expiratory Volume in the First Second (FEV?)/Forced Vital Capacity (FVC) ratio <70%, accompanied by acute changes in dyspnea, cough, and/or sputum production symptoms that exceed the range of normal day-to-day variations. 2. Aged 18 years or older, with a family member serving as the primary caregiver. 3. Possess adequate communication, verbal expression, and comprehension abilities. 4. Voluntary participation in this study with signed informed consent. Inclusion Criteria for Caregivers of COPD Patients: 1. Spouse caregivers with intact cognitive function who are capable of comprehending the questionnaire content; 2. Aged 18 years or older; 3. Serving as the primary caregiver for the patient, defined according to reference [66] as providing care for >= 4 hours per day with a cumulative caregiving duration of >= 90 days; 4. Voluntary participation in this study with signed informed consent.

排除标准：

COPD患者排除标准： （1）合并其它严重疾病，如恶性肿瘤等； （2）认知功能不正常或患有精神方面的疾病； （3）正在参与其它干预研究。 COPD患者家属照顾者排除标准： （1）家属照顾者本人患有严重躯体疾病或精神障碍，自身健康水平严重受损； （2）正在进行其它干预研究的家属照顾者。

Exclusion criteria：

Exclusion Criteria for COPD Patients: 1. Presence of other serious comorbidities, such as malignant tumors; 2. Cognitive impairment or diagnosed with psychiatric disorders; 3. Concurrent participation in other interventional studies. Exclusion Criteria for Family Caregivers of COPD Patients: 1. Family caregivers diagnosed with severe physical illness or psychiatric disorders resulting in significantly compromised health status; 2. Family caregivers currently participating in other interventional studies.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-01 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 267

Group：

Intervention group

Sample size：

干预措施：

基于模型，设计包括教育和技术支持的多模态COPD患者及照顾者健康素养双主体协同促进方案干预措施。教育部分可能包括疾病知识、自我管理技能培训、戒烟日记、用药提醒及症状日志功能，记录使用频率与用户反馈等；技术支持可能包括使用移动健康应用、远程监测设备等。

干预措施代码：

 1

Intervention：

Based on the theoretical model, we designed multimodal intervention strategies for the dual-subject collaborative health literacy promotion program involving both COPD patients and their caregivers, integrating educational and technical support components. The educational component may encompass disease-specific knowledge provision, self-management skills training, smoking cessation diaries, medication reminder systems, and symptom logging functions, alongside tracking usage frequency and collecting user feedback. The technical support component may involve the utilization of mobile health (mHealth) applications and remote monitoring devices.

Intervention code：

组别：

对照组

样本量：

 267

Group：

Control group

Sample size：

干预措施：

对照组则不接受干预，只接受常规护理。

干预措施代码：

 2

Intervention：

The control group will receive routine care only, without intervention.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 深圳市 

Country：

China

Province：

Guangdong Province

City：

Shenzhen City

单位(医院)：

 广州中医药大学深圳医院(福田) 

单位级别：

 三级甲等中医医院 

Institution
hospital：

Shenzhen Hospital (Futian) of Guangzhou University of Chinese Medicine

Level of the institution：

Tertiary Grade-A Traditional Chinese Medicine Hospital

测量指标：

Outcomes：

指标中文名：

COPD患者健康素养水平

指标类型：

主要指标

Outcome：

Health literacy level of COPD patients

Type：

Primary indicator

测量时间点：

6个月

测量方法：

调查问卷

Measure time point of outcome：

6 months

Measure method：

Questionnaire

指标中文名：

COPD患者急性发作再入院率

指标类型：

次要指标

Outcome：

Readmission rate for acute exacerbation in COPD patients

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

COPD患者自我管理能力

指标类型：

次要指标

Outcome：

Self-management ability of COPD patients

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：

无

Sample Name：

None

Tissue：

None

人体标本去向

 使用后销毁  

说明

无

Fate of sample：

Destruction after use  

Note：

None

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 18 岁 years
最大 Max age 90 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）：

采用随机区组设计（randomized block design）进行随机分配。由独立于本研究实施和结局评估的第三方统计学家（或：独立的生物统计学家/数据管理人员）使用统计软件 SAS 9.4（或 SPSS 26.0/R 4.2）的随机数字生成器产生随机序列。 具体实施细节： 区组设置：设定区组长度（block size）为 4 或 6（具体长度对研究人员设盲，不予以公开），确保干预组与对照组在各时间段内分配人数均衡。 分配比例：按 1:1 比例将受试者随机分配至干预组或对照组。 分层因素（如适用）：根据基线病情严重程度（ GOLD 分级）或年龄进行分层随机化，确保组间基线可比性。 分配隐藏（Allocation Concealment）：采用中心随机系统（或：按顺序编码、密封不透光的信封，sequentially numbered, opaque, sealed envelopes, SNOSE）进行分配隐藏。研究者仅在确定受试者符合入组标准后，方可按顺序获取随机号及分组信息，避免选择偏倚。

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

Randomization was performed using a randomized block design. The random sequence was generated by an independent third-party statistician (or: independent biostatistician/data manager) who was not involved in study implementation or outcome assessment, using the random number generator in SAS 9.4 (or SPSS 26.0/R 4.2) statistical software. Specific Implementation Details: Block Configuration: Block sizes were set to 4 or 6 (the specific block length was concealed from the investigators to maintain blinding), ensuring balanced allocation between the intervention and control groups within each time period. Allocation Ratio: Participants were randomly assigned to the intervention group or control group in a 1:1 ratio. Stratification Factors (if applicable): Stratified randomization was performed based on baseline disease severity (GOLD classification/stage) or age to ensure baseline comparability between groups. Allocation Concealment: Allocation concealment was achieved using a central randomization system (or: sequentially numbered, opaque, sealed envelopes [SNOSE]). Investigators obtained the randomization number and group assignment sequentially only after confirming that the participant met the inclusion criteria, thereby preventing selection bias.

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：

鉴于干预性质，本研究采用单盲设计（single-blind）：受试者及干预实施者知晓分组，但结局评估员和统计分析师对分组设盲。区组长度对临床研究人员保密，采用中心随机系统确保分配隐藏。为减少信息偏倚，对照组接受匹配时长的常规护理关注，所有主观结局由经培训且不知晓分组的独立评估员使用标准化工具采集。

Blinding：

Given the nature of the intervention, this study adopted a single-blind design: participants and intervention providers were aware of group assignment, while outcome assessors and statistical analysts were blinded to group allocation. The block size was concealed from clinical investigators, and a central randomization system was employed to ensure allocation concealment. To minimize information bias, the control group received matched attention (equal duration of routine care contact). All subjective outcomes were collected by independent, trained assessors who were blinded to group assignment using standardized instruments.

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(Case Record Form, CRF)

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：

  2026-02-28 17:51:26