ChiCTR2600125851 版本V1.0 版本创建时间2026/06/01 11:49:36 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：

 ChiCTR2600125851 

最近更新日期：

Date of Last Refreshed on：

 2026-06-01 11:49:30 

注册时间：

Date of Registration：

 2026-06-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

全面构建与实施“六高”人群公众健教体系

Public title：

Comprehensively Establish and Implement a Aublic Health Education System for The "Six High" Risk Population

注册题目简写：

English Acronym：

研究课题的正式科学名称：

全面构建与实施“六高”人群公众健教体系

Scientific title：

Comprehensively Establish and Implement a Aublic Health Education System for The "Six High" Risk Population

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：

赵玉 

研究负责人：

赵玉 

Applicant：

Yu Zhao 

Study leader：

Yu Zhao 

申请注册联系人电话：

Applicant telephone：

 +86 183 1455 7559

研究负责人电话：

Study leader's
telephone：

+86 871 6852 1285

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：

 1137950958@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1137950958@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：

云南省昆明市五华区上悦天地云归苑3栋1602号

研究负责人通讯地址：

云南省昆明市五华区西北新区沙河北路528号

Applicant address：

Room 1602, Building 3, Yunguiyuan, Shangyue Tiandi, Wuhua District, Kunming City, Yunnan Province

Study leader's address：

No.528 Shahe North Road, Northwest New District, Wuhua District, Kunming, Yunnan 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：

云南省阜外心血管病医院

Applicant's institution：

Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences

研究负责人所在单位：

云南省阜外心血管病医院

Affiliation of the Leader：

Fuwai Yunnan Cardiovascular 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：

 2025-107-02

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：

云南省阜外心血管病医院科研和新技术伦理委员会

Name of the ethic committee：

Ethics Committee of Scientific Research and New Technology, Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-01 00:00:00

伦理委员会联系人：

王宝松

Contact Name of the ethic committee：

Wang BaoSong

伦理委员会联系地址：

云南省昆明市五华区西北新区沙河北路528号

Contact Address of the ethic committee：

No.528 Shahe North Road, Northwest New District, Wuhua District, Kunming, Yunnan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 871 6828 5630

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 2628648276@qq.com

研究实施负责（组长）单位：

云南省阜外心血管病医院

Primary sponsor：

Fuwai Yunnan Cardiovascular Hospital

研究实施负责（组长）单位地址：

云南省昆明市五华区西北新区沙河北路528号

Primary sponsor's address：

No.528 Shahe North Road, Northwest New District, Wuhua District, Kunming, Yunnan 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)：

云南省

市(区县)：

Country：

China

Province：

Yunnan

City：

单位(医院)：

云南省阜外心血管病医院

具体地址：

云南省昆明市五华区西北新区沙河北路528号

Institution
hospital：

Fuwai Yunnan Cardiovascular Hospital

Address：

No.528 Shahe North Road, Northwest New District, Wuhua District, Kunming, Yunnan Province

经费或物资来源：

全面构建与实施“六高”人群公众健教体系

Source(s) of funding：

Supported by the Program of Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences

研究疾病：

高血压、高血糖、血脂异常、高尿酸、高体重指数和高心理压力。  

Target disease：

Hypertension, Hyperglycemia, Dyslipidemia, Hyperuricemia, High body mass index (BMI), High psychological stress.

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

1、建立云南省昆明市社区全覆盖的“六高共管”公众健教体系。 2、组建一支高水平、专业性强的公众“六高共管”健教管理团队。 3、全面提高云南省社区居民对ASCVD危险因素的知晓率、治疗率及达标率，降低ASCVD发病率。 4、显著提高“六高”人群的总体生活质量：通过为“六高”人群提供个性化、针对性的健康管理方案，改善居民的身体状况、心理状况和社会适应能力，达到提高“六高”人群生活质量的目的。  

Objectives of Study：

1.Establish a community-wide public health education system for the 'Six Highs' co-management in Kunming City, Yunnan Province.2.Form a high-level, professional public health education management team for the 'Six Highs' co-management.3.Comprehensively improve the awareness rate, treatment rate, and compliance rate of ASCVD risk factors among community residents in Yunnan Province, and reduce the incidence of ASCVD.Significantly improve the overall quality of life for the 'Six Highs' population,4.By providing personalized and targeted health management programs, we aim to enhance residents' physical and psychological well-being, as well as social adaptability, ultimately achieving the goal of elevating their quality of life.

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18-70岁（包含边界值），男女均可；
2.符合“六高”诊断标准中的任两项；
3.在目标社区常住（每年居住时间≥9个月）；
4.研究参与者自愿加入研究，签署知情同意，依从性好，配合随访；

Inclusion criteria

1.Aged 18 to 70 years old (inclusive), both males and females are eligible; 2.Meet any two of the diagnostic criteria for the "Six Highs"; 3.Permanent resident in the target community (residing for >= 9 months per year); 4.Study participants voluntarily join the study, sign informed consent, have good compliance, and cooperate with follow-up;

排除标准：

1.患有严重的心、脑、肝、肾等器质性疾病或肿瘤终末期患者；
2.患有严重的认知障碍、精神疾病，无法进行有效沟通或完成问卷调查者；
3.长期卧床、行动不便，无法参与集体健康教育活动者；
4.已经参与其他类似的慢性病干预项目者；

Exclusion criteria：

1.Patients with severe organic diseases of the heart, brain, liver, kidneys, or other organs, or those with end-stage tumors;
2.Individuals with severe cognitive impairment or mental illness who are unable to communicate effectively or complete the questionnaire survey;
3.Those who are bedridden for a long time, have mobility difficulties, and are unable to participate in collective health education activities;
4.Participants who have been involved in other similar chronic disease intervention programs;

研究实施时间：

Study execute time：

从 From 2025-03-01 00:00:00至 To 2028-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

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

干预措施：

Interventions：

组别：

干预组

样本量：

 200

Group：

Intervention group

Sample size：

干预措施：

实施一套“科技赋能+社区参与+个体精准”的全方位干预体系

干预措施代码：

Intervention：

Implement a comprehensive intervention system featuring "technology empowerment + community participation + individual precision"

Intervention code：

组别：

对照组

样本量：

 200

Group：

Control group

Sample size：

干预措施：

维持常规的健康教育，如社区卫生服务中心宣传栏、健康讲座等

干预措施代码：

Intervention：

Maintain routine health education, such as bulletin boards and health lectures at community health service centers

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南省 

市(区县)：

  

Country：

China

Province：

Yunnan

City：

单位(医院)：

 云南省阜外心血管病医院 

单位级别：

 三级甲等 

Institution
hospital：

Fuwai Yunnan Cardiovascular Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

“六高”危险因素相关知识的知晓率、治疗率及控制达标率

指标类型：

主要指标

Outcome：

Awareness rate, treatment rate and control achievement rate of knowledge related to the "Six Highs" risk factors

Type：

Primary indicator

测量时间点：

干预1年后

测量方法：

1.知晓率：对“六高”危险因素相关知识的知晓率提升幅度。（根据六高人群健康知识调查问卷进行计算） 2治疗率：干预后，经医生诊断需药物治疗的“六高”患者中，实际接受规范治疗的比例提升幅度。计算公式：（干预后规范治疗人数-干预前规范治疗人数）/需治疗的总人数×100% 3.控制达标率：干预后各项指标达到以下中国指南推荐标准的研究参与者比例提升幅度。

Measure time point of outcome：

One year after the intervention

Measure method：

1.Awareness rate: The increase in the awareness rate of knowledge related to the "Six Highs" risk factors. (Calculated based on the health knowledge questionnaire for the "Six Highs" population).2.Treatment rate: The increase in the proportion of patients diagnosed by physicians as requiring pharmacotherapy for the "Six Highs" who actually received standardized treatment after the intervention.3.Control achievement rate: The increase in the proportion of study participants whose various indicato

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 18 岁 years
最大 Max age 70 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）：

无

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

None

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）：

预计共享原始数据日期为2027年12月，由通讯作者处获取。

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

Expected sharing time: December 2027, to be obtained from the corresponding author.

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：

数据收集步骤 （1）记录人口统计学数据：年龄、性别、教育程度、工作状态、身高、体重、血压等。（2）其它的实验室检查类，如糖化血红蛋白、血脂、尿酸等相关指标。 （3）问卷调查相关数据：具有3个问卷调查表，分别为六高知晓率问卷调查、中文版感知压力量表、Morisky用药依从性量表。数据管理 （一）数据记录 1. 研究者必须保证数据真实、完整、准确。 2. 研究者在入组受试者后及时填写病例报告表或临床研究数据记录表，保证病例报告表或临床研究数据记录表上的内容与病历内容一致。 3. 研究者记录做任何更正时只能划线，旁注改后的数据，由研究者签名并注明日期，不得擦涂、覆盖原始记录。 4. 实验室检查项目齐全且均可溯源。 5. 每例受试者数据收集结束后，研究者应及时填写好病例报告表或临床研究数据记录表上相关数据，并交本中心主要研究者审核、签名确认。（二）数据管理 1. 数据的可溯源性、病例报告表或临床研究数据记录表的填写与移交 原始记录（原始病历、检查报告单等）需妥善保存。病例报告表或临床研究数据记录表的数据均来源于原始病历，由研究者填写，每个入选获得编码的病例必须完成病例报告表或临床研究数据记录表。完成的病例报告表或临床研究数据记录表由主要研究者审查后交数据管理员，进行数据录入与管理工作。 2. 数据库的设计及建立 建立临床研究数据库，记录病例报告表或临床研究数据记录表中所有的信息。数据库的格式将尽量与病例报告表或临床研究数据记录表的格式相对应以方便录入的进行。 3. 数据的录入与修改 为保证数值型数据的准确性，使用Excel进行数据双份录入并校对，对病例报告表或临床研究数据记录表中存在的疑问，数据管理员将填写疑问解答表（Data Rating Questionnaire，DRQ），并向研究者发出询问，研究者应尽快解答并返回，数据管理员根据研究者的回答进行数据修改，确认与录入，必要时可以再次发出DRQ。 4. 数据核查 数据的核查将分为人工核查和系统核查。人工核查是数据管理员通过检查数据的一致性、逻辑性等手段发现错误，产生DRQ。系统核查或程序性检查是指通过计算机程序的方法对CRF中的数据进行核查，包括范围，逻辑关系，一致性，方案的违背和偏离等。所产生的DRQ将交给研究者进行再次确定。有关的修改需要研究者签名并注明日期。 5. 数据锁定 当满足以下条件时，即可锁定数据： ①全部数据均已录入数据库并经过双份核对。 ②全部疑问均已解决。 ③分析人群已定义并做出判断。 6. 数据处理在数据锁定后，将数据库交统计分析人员进行统计分析，并撰写统计分析报告完成。

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

Data Collection Procedures：(1) Record demographic data: age, gender, educational level, employment status, height, weight, blood pressure, etc.(2) Other laboratory test items, such as glycosylated hemoglobin, blood lipids, uric acid and other related indicators.(3) Questionnaire-related data: Three questionnaires are used, namely the "Six Highs" Awareness Questionnaire, the Chinese Version of the Perceived Stress Scale, and the Morisky Medication Adherence Scale.Data Management (I) Data recording 1. Researchers must ensure that the data are true, complete and accurate. 2. The investigator shall fill in the case report form or clinical research data record form in time after the subjects are enrolled to ensure that the contents on the case report form or clinical research data record form are consistent with the contents of the medical records. 3. Any corrections to the records of the investigator shall be underlined only, and the corrected data shall be signed and dated by the investigator. The original records shall not be erased or overwritten. 4. The laboratory examination items are complete and traceable. 5. After the data collection of each subject, the investigator shall fill in the case report form or the relevant data on the clinical research data record form in time, and submit it to the principal investigator of the center for review and signature for confirmation. (II) Data management 1. Data traceability, filling and handover of case report form or clinical study data record form Original records (original medical records, examination reports, etc.) shall be kept properly. The data in the case report form or the clinical study data record form are from the original medical records and are filled in by the investigator. Each case enrolled and coded must complete the case report form or the clinical study data record form. The completed case report form or clinical study data record form shall be reviewed by the principal investigator and then submitted to the data administrator for data entry and management. 2. Design and establishment of database Establish the clinical research database and record all the information in the case report form or clinical research data record form. The format of the database will correspond to the format of the case report form or the clinical study data record form as far as possible to facilitate the entry. 3. Data entry and modification In order to ensure the accuracy of numerical data, Excel is used for double data entry and proofreading. For questions in the case report form or clinical research data record form, the data administrator will fill in the Data Rating Questionnaire (DRQ) and send a query to the investigator. The researcher shall answer and return as soon as possible, and the data administrator shall modify, confirm and input the data according to the researcher's answer, and issue the DRQ again if necessary. 4. Data verification Data verification will be divided into manual verification and systematic verification. Manual verification means that data administrators find errors by checking the consistency and logicality of data and generate DRQ. System check or procedural check refers to the check of data in CRF by means of computer program, including scope, logical relationship, consistency, scheme violation and deviation, etc. The resulting DRQ will be submitted to the investigator for reconfirmation. The relevant amendment shall be signed and dated by the investigator. 5. Data lock Data can be locked when the following conditions are met: ① All data have been entered into the database and checked in duplicate. ② All questions have been resolved. ③ The analysis population has been defined and judged. 6. Data processing After the data is locked, the database will be submitted to the statistical analyst for statistical analysis, and the statistical analysis report will be written.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-01 11:49:30