ChiCTR2600115981 版本V1.0 版本创建时间2026/01/04 14:44:31 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：

ChiCTR2600115981 

最近更新日期：

Date of Last Refreshed on：

2026-01-04 14:44:18 

注册时间：

Date of Registration：

2026-01-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

居家社区养老视域下医养结合分级模式构建及试点评估

Public title：

Theory development and pilot evaluation of a hierarchical model of integrated health and social care for older people from the perspective of home and community-based care service

注册题目简写：

English Acronym：

研究课题的正式科学名称：

居家社区养老视域下医养结合分级模式构建及试点评估

Scientific title：

Theory development and pilot evaluation of a hierarchical model of integrated health and social care for older people from the perspective of home and community-based care service

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：

闵鹤葳 

研究负责人：

张旭熙 

Applicant：

Hewei Min 

Study leader：

Xuxi Zhang 

申请注册联系人电话：

Applicant telephone：

+86 138 9524 5367

研究负责人电话：

Study leader's telephone：

+86 82801519

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：

minhewei06@163.com

研究负责人电子邮件：

Study leader's E-mail：

xuxizhang@bjmu.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：

北京市海淀区学院路38号

研究负责人通讯地址：

北京市海淀区学院路38号

Applicant address：

No. 38 Xueyuan Road, Haidian District, Beijing

Study leader's address：

No. 38 Xueyuan Road, Haidian District, Beijing

申请注册联系人邮政编码：

Applicant postcode：

100191

研究负责人邮政编码：

Study leader's postcode：

100191

申请人所在单位：

北京大学公共卫生学院社会医学与健康教育系

Applicant's institution：

Department of Social Medicine and Health Education, School of Public Health, Peking University

研究负责人所在单位：

北京大学

Affiliation of the Leader：

Peking University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

IRB00001052-25127

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：

北京大学生物医学伦理委员会

Name of the ethic committee：

Peking University Institutional Review Board

伦理委员会批准日期：

Date of approved by ethic committee：

2025-10-20 00:00:00

伦理委员会联系人：

李洁

Contact Name of the ethic committee：

Jie Li

伦理委员会联系地址：

北京市海淀区学院路38号北京大学医学部逸夫楼501室

Contact Address of the ethic committee：

Room 501, Shaw Building, Peking University Health Science Center, No. 38 Xueyuan Road, Haidian District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8280 5751

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：

北京大学

Primary sponsor：

Peking University

研究实施负责（组长）单位地址：

北京市海淀区学院路38号

Primary sponsor's address：

No. 38 Xueyuan Road, Haidian District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京大学公共卫生学院社会医学与健康教育系

具体地址：

北京市海淀区学院路38号

Institution
hospital：

Department of Social Medicine and Health Education, School of Public Health, Peking University

Address：

No. 38 Xueyuan Road, Haidian District, Beijing

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

Target disease：

Type 2 diabetes and/or hypertension

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：

本项目以探索居家社区养老视域下的医养结合分级模式理论框架和实施方案为总体目标，以居家养老端为切入点，设计基于老年人自理能力和健康水平的居家养老端医养结合分级供给方案，应用混合方法研究的整群随机对照试验设计，开展以社区助老食堂为平台的“医”与“养”融合试点评估，验证理论框架和实施方案可行性，形成居家社区养老视域下有针对性、可推广、可持续的居家养老端医养结合分级服务清单和实施方案，以期增强居家社区医养结合实施可行性，推动医养结合服务模式的创新，提升老年人生活质量和满意度，为未来开展居家社区医养结合提供试点改革依据和科学数据参考。  

Objectives of Study：

The overall goal of this project is to explore the theoretical framework and implementation plan of a hierarchical model for the integration of medical and elderly care from the perspective of home and community-based elderly care. Taking home-based elderly care as the entry point, it designs a hierarchical supply plan for the integration of medical and elderly care at the home end based on the self-care ability and health status of the elderly. Adopting a cluster randomized controlled trial design under mixed methods research, the project conducts a pilot evaluation on the integration of "medical services" and "elderly care services" with community elderly canteens as the platform to verify the feasibility of the theoretical framework and implementation plan. Ultimately, it aims to formulate targeted, promotable and sustainable hierarchical service lists and implementation plans for the integration of medical and elderly care at the home end under the perspective of home and community-based elderly care. This is intended to enhance the feasibility of implementing the integration of medical and elderly care in home and community settings, promote the innovation of service models for the integration of medical and elderly care, improve the quality of life and satisfaction of the elderly, and provide pilot reform basis and scientific data reference for the future development of the integration of medical and elderly care in home and community contexts.

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. 为医养结合1级、2级、3级或4级人群； 其中，医养结合1级为： ①被明确诊断的 2 型糖尿病和/或高血压患者，或血压异常（收缩压≥140mmHg 和/或舒张压≥90mmHg）和/或血糖异常（空腹血糖≥7.0mmol/L 或 OGTT2 小时血糖≥11.1mmol/L 或 HbA1C≥6.5%），或正在接受降压治疗和/或正在接受降血糖治疗；②能够自理；③年龄≥60 岁；④居住在社区的居家养老人群； 医养结合2级为： ①疾病康复或终末期或出院后仍需医疗服务的老年人；②能够自理；③年龄≥60 岁；④居住在社区的居家养老人群； 医养结合3级为：①被明确诊断的 2 型糖尿病和/或高血压患者，或血压异常（收缩压≥140mmHg 和/或舒张压≥90mmHg）和/或血糖异常（空腹血糖 ≥7.0mmol/L 或 OGTT2 小时血糖≥11.1mmol/L 或 HbA1C≥6.5%），或正在接受降压治疗和/或正在接受降血糖治疗；②部分自理；③年龄≥60 岁；④居住在社区的居家养老人群； 医养结合4级为：①疾病康复或终末期或出院后仍需医疗服务的老年人；②部分自理；③年龄≥60 岁；④居住在社区的居家养老人群。 2. 试点社区常住人口（年外出时间小于 1 个月）； 3. 会使用智能手机； 4. 自愿参加研究，填写知情同意书

Inclusion criteria

1. Classification into Tier 1, 2, 3, or 4 of the integrated healthcare and elderly care model: Tier 1: Individuals who meet the following criteria: (1) Have a confirmed diagnosis of type 2 diabetes and/or hypertension, OR exhibit abnormal blood pressure (systolic BP >=140mmHg and/or diastolic BP >=90mmHg) and/or abnormal blood glucose (fasting blood glucose >=7.0mmol/L OR OGTT 2-hour blood glucose >=11.1mmol/L OR HbA1c >=6.5%), OR are currently receiving antihypertensive treatment and/or hypoglycemic treatment; (2)Are capable of self-care; (3) Are aged >=60 years; (4)Are community-dwelling older adults receiving home-based care. Tier 2: Individuals who meet the following criteria: (1) Are older adults requiring medical services during convalescence, at the end-of-life stage, or after hospital discharge; (2)Are capable of self-care; (3) Are aged >=60 years; (4)Are community-dwelling older adults receiving home-based care. Tier 3: Individuals who meet the following criteria: (1) Have a confirmed diagnosis of type 2 diabetes and/or hypertension, OR exhibit abnormal blood pressure (systolic BP >=140mmHg and/or diastolic BP >=90mmHg) and/or abnormal blood glucose (fasting blood glucose >=7.0mmol/L OR OGTT 2-hour blood glucose >=11.1mmol/L OR HbA1c >=6.5%), OR are currently receiving antihypertensive treatment and/or hypoglycemic treatment; (2)Are partially capable of self-care; (3) Are aged >=60 years; (4)Are community-dwelling older adults receiving home-based care. Tier 4: Individuals who meet the following criteria: (1) Are older adults requiring medical services during convalescence, at the end-of-life stage, or after hospital discharge; (2)Are partially capable of self-care; (3) Are aged >=60 years; (4)Are community-dwelling older adults receiving home-based care. 2. Permanent resident of the pilot community (defined as being away from the community for less than one month per year). 3. Able to use a smartphone. 4. Voluntary participation in the study and provision of signed informed consent.

排除标准：

1. 患有继发性高血压或糖尿病； 2. 严重认知障碍，如阿尔兹海默病、血管性痴呆、路易体痴呆等； 3. 同时患有肿瘤，近半年内接受放疗、化疗者； 4. 患有终末期肾病、终末期肺炎、重度心力衰竭等预计无法完成整个干预周期的终末期疾病； 5. 患有系统性红斑狼疮、免疫缺陷病、HIV 阳性等严重免疫系统疾病； 6. 神志不清、精神异常者，如精神分裂症、重度抑郁症等； 7. 药物滥用或酗酒，或近一年内参与过任何药物试验者； 8. 正在参加其他类似研究课题者； 9. 拒绝参加本研究

Exclusion criteria：

1. Diagnosis of secondary hypertension or diabetes mellitus. 2. Severe cognitive impairment (e.g., Alzheimer's disease, Vascular dementia, Dementia with Lewy bodies). 3. Concurrent diagnosis of cancer, having undergone radiotherapy or chemotherapy within the past six months. 4. Diagnosis of end-stage diseases where completion of the entire intervention cycle is not anticipated (e.g., end-stage renal disease, end-stage pneumonia, severe heart failure). 5. Severe immune system disorders (e.g., Systemic lupus erythematosus, Immunodeficiency diseases, HIV positive). 6. Individuals with impaired consciousness or severe psychiatric disorders (e.g., Schizophrenia, Major depressive disorder). 7. History of substance abuse or alcohol dependence, or participation in any drug clinical trials within the past year. 8. Current participation in other similar interventional research studies. 9. Unwillingness to participate in this study.

研究实施时间：

Study execute time：

从 From 2025-12-15 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-05 00:00:00 至 To 2028-11-01 00:00:00  

干预措施：

Interventions：

组别：

对照组1

样本量：

100

Group：

Control group1

Sample size：

干预措施：

常规社区管理；医养结合1,2级老人

干预措施代码：

Intervention：

Usual Community Care for Tier 1 and 2 of the integrated healthcare and elderly care model

Intervention code：

组别：

干预组1

样本量：

100

Group：

Intervention group 1

Sample size：

干预措施：

助老食堂干预；医养结合1,2级老人

干预措施代码：

Intervention：

Community Canteen-Based Intervention for Tier 1 and 2 of the integrated healthcare and elderly care model

Intervention code：

组别：

干预组2

样本量：

100

Group：

Intervention group 2

Sample size：

干预措施：

线上+食堂干预；；医养结合3，4级老人

干预措施代码：

Intervention：

Integrated Online and Senior Meal Service Intervention for Tier 3 and 4 of the integrated healthcare and elderly care model

Intervention code：

组别：

对照组2

样本量：

100

Group：

Control group2

Sample size：

干预措施：

常规社区管理；医养结合3,4级老人

干预措施代码：

Intervention：

Usual Community Care for Tier 1 and 2 of the integrated healthcare and elderly care model

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

  

Country：

China 

Province：

Shandong 

City：

 

单位(医院)：

山东省疾病预防控制中心 

单位级别：

无 

Institution
hospital：

Shandong Provincial Center for Disease Control and Prevention

Level of the institution：

N/A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京大学公共卫生学院社会医学与健康教育系 

单位级别：

大学 

Institution
hospital：

Department of Social Medicine and Health Education, School of Public Health, Peking University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

体重指数

指标类型：

主要指标

Outcome：

Body Mass Index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腰臀比

指标类型：

主要指标

Outcome：

Waist-to-Hip Ratio

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血压

指标类型：

主要指标

Outcome：

Blood Pressure

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

健康相关生活质量

指标类型：

次要指标

Outcome：

Health-related life quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

健康相关行为

指标类型：

次要指标

Outcome：

Health-related behavior

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 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）：

研究人员利用限制性随机化的方法对整群进行随机分组。根据地理位置将所有集群分成不同的“层”。在每一个层内，独立地进行一次简单随机化，将层内的集群分配到不同组别。

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

The researchers used a restricted randomization method to randomly assign the clusters into groups. All clusters were divided into different "strata" based on their geographical locations. Within each stratum, a simple randomization was independently conducted to assign the clusters within the stratum to different groups.

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：

开放标签，对评估者隐藏分组

Blinding：

Open-label, assessor-blinded to group assignment

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

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：

本研究存档数据由人工搜集的纸质数据和在线平台存储的电子数据文件构成，纸质数据包括研究者要求受访者填写的知情同意书、部分问卷内容；电子数据包括访谈音频、以及受试者填写的电子问卷。其中，纸质数据在按要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录，以备查考；电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。所有原始档案按相应规定内的期限保存。

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

The archived data from this study consists of manually collected paper-based records and electronically stored data files from an online platform. The paper-based data includes informed consent forms and sections of questionnaires completed by the respondents as required by the researchers. The electronic data comprises interview audio recordings and digitally completed questionnaires. The paper-based records are archived sequentially by identification number upon completion of data entry and verification, accompanied by a searchable index for future reference. Electronic data files—including databases, inspection procedures, analytical programs, analysis results, codebooks, and documentation—are categorized and stored with multiple backups maintained on separate disks or storage media to ensure preservation and prevent damage. All original records are retained in accordance with the stipulated retention period as per relevant regulations.

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：

  2026-01-04 14:44:18