城乡老年人健康老龄化研究

注册号:

Registration number:

ChiCTR2500106612 

最近更新日期:

Date of Last Refreshed on:

2025-07-28 08:41:02 

注册时间:

Date of Registration:

2025-07-28 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

城乡老年人健康老龄化研究

Public title:

Healthy Ageing Rural–urban Population Study (HARPS)

注册题目简写:

English Acronym:

研究课题的正式科学名称:

城乡老年人健康老龄化状况及多维影响因素调查研究

Scientific title:

Research on the Healthy Aging Status and Multidimensional Influencing Factors of Older People in Urban and Rural Areas

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:

李少杰 

研究负责人:

任龙兵 

Applicant:

Shaojie Li 

Study leader:

Longbing Ren 

申请注册联系人电话:

Applicant telephone:

+86 178 6419 1208

研究负责人电话:

Study leader's
telephone:

+86 186 1385 8523

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:

li_shaojie@hsc.pku.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

renlongbing@hsc.pku.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:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

北京大学公共卫生学院

Applicant's institution:

School of Public Health, Peking University

研究负责人所在单位:

北京大学中国卫生发展研究中心

Affiliation of the Leader:

China Center for Health Development Studies, Peking University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

IRB00001052-25006

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:

Biomedical Ethics Committee of Peking University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-02-23 00:00:00

伦理委员会联系人:

刘珍慧

Contact Name of the ethic committee:

Zhenhui Liu

伦理委员会联系地址:

北京市海淀区学院路38号

Contact Address of the ethic committee:

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:

北京大学中国卫生发展研究中心

Primary sponsor:

China Center for Health Development Studies, 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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学中国卫生发展研究中心

具体地址:

北京市海淀区学院路38号

Institution
hospital:

China Center for Health Development Studies, 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

研究疾病:

健康老龄化  

Target disease:

Healthy Ageing

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

队列研究 

Study design:

Cohort study 

研究目的:

根据世界卫生组织健康老龄化框架,选取中国城乡老年人进行调查,收集城乡老年人健康老龄化状况及多维影响因素。  

Objectives of Study:

In accordance with the World Health Organization Healthy Ageing framework, this study will survey older adults in both urban and rural China to collect data on their healthy ageing status and a wide range of associated determinants.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.存在听力、语言障碍; 2.患有恶性肿瘤、痴呆症、精神分裂症等严重疾病; 3.失能无法参与调查者。

Exclusion criteria:

1. Hearing and language impairments; 2. Suffering from serious diseases such as malignant tumors, dementia, and schizophrenia; 3. Those who are disabled and unable to participate in the survey.

研究实施时间:

Study execute time:

From 2025-01-01 00:00:00 To 2027-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-08-01 00:00:00 To 2025-08-30 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

2830

Group:

Observation group

Sample size:

干预措施:

无干预措施,为自然人群的观察性研究

干预措施代码:

Intervention:

Observational study of natural population without intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

山东省 

市(区县):

济南市 

Country:

China

Province:

Shandong Province

City:

Jinan City

单位(医院):

社区卫生服务中心或村卫生室 

单位级别:

社区卫生服务中心 

Institution
hospital:

Community health service center or village clinic

Level of the institution:

Community health service center

国家:

中国

省(直辖市):

上海市 

市(区县):

上海市 

Country:

China

Province:

Shanghai City

City:

Shanghai City

单位(医院):

社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Community health service center

Level of the institution:

Community health service center

国家:

中国

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China

Province:

Hunan Province

City:

Changsha City

单位(医院):

社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Community health service center

Level of the institution:

Community health service center

测量指标:

Outcomes:

指标中文名:

身体健康状况

指标类型:

主要指标

Outcome:

Physical health status

Type:

Primary indicator

测量时间点:

测量方法:

采用调查表和客观仪器询问及测量老年人身体健康状况,包括患病状况、服药情况、性格类型、身高、体重、腰围、体型、耳鸣情况、跌倒、听力、视力、嗅觉、吞咽能力、咀嚼能力、平衡能力、步速、头晕症状、触觉、口腔健康、压力、疲劳、干眼症状、便秘情况、衰弱、皮肤状况、发量、肌肉减少症、营养状况、身体疼痛、睡眠情况等

Measure time point of outcome:

Measure method:

Physical health will be evaluated with questionnaires and objective instruments that inquire about and measure disease history, medication use, personality type, height, weight, waist circumference, body shape, tinnitus, falls, hearing, vision, olfaction, swallowing ability, chewing ability, balance, gait speed, dizziness, tactile sensation, oral health, stress, fatigue, dry-eye symptoms, constipation, frailty, skin condition, hair volume, sarcopenia, nutritional status, pain, sleep, etc.

指标中文名:

心理健康状况

指标类型:

主要指标

Outcome:

Mental health status

Type:

Primary indicator

测量时间点:

测量方法:

心理健康将通过结构化问卷和经过验证的量表进行评估,包括抑郁症状、焦虑症状、孤独感、囤积倾向、悲伤等。

Measure time point of outcome:

Measure method:

Mental health will be assessed with structured questionnaires and validated scales that measure depressive symptoms, anxiety symptoms, loneliness, hoarding tendencies, grief, and related aspects.

指标中文名:

社会关系和网络

指标类型:

主要指标

Outcome:

Social relationships and networks

Type:

Primary indicator

测量时间点:

测量方法:

使用调查表和经验证的量表测量社会网络、感知歧视和负面社会经历

Measure time point of outcome:

Measure method:

Social networks, perceived discrimination, and adverse social experiences will be assessed using questionnaires and validated scales.

指标中文名:

日常生活自理能力

指标类型:

主要指标

Outcome:

Activities of daily living

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能

指标类型:

主要指标

Outcome:

Cognitive function

Type:

Primary indicator

测量时间点:

测量方法:

简易精神状态检查量表(MMSE)

Measure time point of outcome:

Measure method:

Mini-Mental State Examination

指标中文名:

健康相关生命质量

指标类型:

主要指标

Outcome:

Health-related quality of life

Type:

Primary indicator

测量时间点:

测量方法:

12项简表调查(SF-12)

Measure time point of outcome:

Measure method:

12-Item Short Form Survey (SF-12)

指标中文名:

韧性

指标类型:

主要指标

Outcome:

Resilience

Type:

Primary indicator

测量时间点:

测量方法:

身体韧性将使用老年人身体韧性量表(PRIFOR)进行测量,心理韧性将使用简明韧性量表进行评估。

Measure time point of outcome:

Measure method:

Physical resilience will be measured with the Physical Resilience Instrument for Older Adults (PRIFOR), and psychological resilience will be assessed with the Brief Resilience Scale.

指标中文名:

社会人口学特征

指标类型:

次要指标

Outcome:

Sociodemographic characteristics

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活方式和行为习惯

指标类型:

次要指标

Outcome:

Lifestyle and behavioral habits

Type:

Secondary indicator

测量时间点:

测量方法:

采用自编的调查表,包括睡眠时间、饮水量、饮食口味偏好、食用油及偏好、膳食补充剂使用、喝酒频率、吸烟频率、常规膳食摄入、加工食品摄入、体力活动、久坐行为、口腔健康行为、活动参与状况、饮食安排、做饭技能、观看天气预报的习惯、助听器使用、老花镜使用、电子设备使用等。

Measure time point of outcome:

Measure method:

A self-designed questionnaire will collect sleep duration, daily water intake, taste preferences, types and preferred use of cooking oils, consumption of dietary supplements, frequency of alcohol drinking and smoking, routine dietary intake, processed-food consumption, physical activity level, sedentary time, oral-health practices, participation in activities, meal planning, cooking skills, habit of watching weather forecasts, use of hearing aids, use of reading glasses, and use of electronic de

指标中文名:

健康服务利用

指标类型:

次要指标

Outcome:

Health service utilization

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

居住环境

指标类型:

次要指标

Outcome:

Residential environment

Type:

Secondary indicator

测量时间点:

测量方法:

采用自编的居住环境调查表询问老年人的居住环境和小区/村庄环境。家庭居住环境包括家中害虫、霉菌、光线、厕所、整洁情况、燃料使用等。小区/村庄环境包括经济水平、步行环境设施、绿化环境、道路环境整洁程度、空气质量、污染情况、设施便捷程度等。

Measure time point of outcome:

Measure method:

A self-developed questionnaire will collect information on the living environment of older adults at both the household and neighborhood/village levels. Household items will cover pests, mold, lighting, toilet facilities, general cleanliness, types of fuel used, etc. Neighborhood or village items will address local economic level, pedestrian facilities, green space, road cleanliness, air quality, pollution, convenience of public amenities, etc.

指标中文名:

生命历程调查

指标类型:

次要指标

Outcome:

Life course survey

Type:

Secondary indicator

测量时间点:

测量方法:

自编调查表询问18岁以前及18-59岁的生活经历与事件

Measure time point of outcome:

Measure method:

Self designed survey to inquire about life experiences and events before the age of 18 and between the ages of 18-59

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

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 years
最大 Max age 100 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):

多阶段分层整群随机抽样法

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

Multi-stage stratified cluster random sampling method

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:

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):

原始数据库将不公开开放,去标识化数据可通过邮件向项目负责人申请

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

The raw database will not be made publicly available. Interested researchers may request deidentified data from the project lead via email.

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:

纸质调查问卷

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

Paper survey questionnaire

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:

 2025-07-28 08:40:43