ChiCTR2400094367 版本V1.0 版本创建时间2024/12/20 16:18:37 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：

ChiCTR2400094367 

最近更新日期：

Date of Last Refreshed on：

2024-12-20 16:17:00 

注册时间：

Date of Registration：

2024-12-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

西北地区城市居住老年口腔健康与全身衰弱相关性及中介因素分析—一项前瞻性队列研究

Public title：

The correlation between oral health and general frailty in elderly residents of Northwest China: a prospective cohort study with mediating factors analysisve cohort study

注册题目简写：

西北地区城市居住老年口腔健康与全身衰弱相关性及中介因素分析—一项前瞻性队列研究

English Acronym：

The correlation between oral health and general frailty in elderly residents of Northwest China: a prospective cohort study with mediating factors analysis

研究课题的正式科学名称：

西北地区城市居住老年口腔健康与全身衰弱相关性及中介因素分析—一项前瞻性队列研究

Scientific title：

The correlation between oral health and general frailty in elderly residents of Northwest China: a prospective cohort study with mediating factors analysis

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：

杨帆 

研究负责人：

杨帆 

Applicant：

Yang Fan 

Study leader：

Yang Fan 

申请注册联系人电话：

Applicant telephone：

+86 135 7248 6228

研究负责人电话：

Study leader's telephone：

+86 135 7248 6228

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：

yangfan@fmmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

yangfan@fmmu.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：

陕西省西安市长乐西路空军军医大学

研究负责人通讯地址：

陕西省西安市长乐西路空军军医大学

Applicant address：

Medical Ethics Committee of the Third Hospital Affiliated to Air Force Medical University

Study leader's address：

Medical Ethics Committee of the Third Hospital Affiliated to Air Force Medical University

申请注册联系人邮政编码：

Applicant postcode：

710032

研究负责人邮政编码：

Study leader's postcode：

710032

申请人所在单位：

空军军医大学第三附属医院

Applicant's institution：

Third Hospital of the Air Force Medical University

研究负责人所在单位：

空军军医大学第三附属医院

Affiliation of the Leader：

Third Hospital of the Air Force Medical 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：

KQ-YJ-2024-142

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：

空军军医大学第三附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Third Hospital Affiliated to Air Force Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-07-22 00:00:00

伦理委员会联系人：

雷蕾

Contact Name of the ethic committee：

Lei Lei

伦理委员会联系地址：

空军军医大学第三附属医院

Contact Address of the ethic committee：

Third Hospital of the Air Force Medical University

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 137 5989 3202

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：

空军军医大学第三附属医院

Primary sponsor：

Third Hospital of the Air Force Medical University

研究实施负责（组长）单位地址：

陕西省西安市新城区长乐西路145号

Primary sponsor's address：

145 Changle West Road, Xincheng District, Xi 'an City, Shaanxi 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)：

陕西

市(区县)：

西安市

Country：

China

Province：

Shaanxi

City：

Xi 'an City

单位(医院)：

陕西省西安市长乐西路空军军医大学

具体地址：

陕西省西安市长乐西路145号

Institution
hospital：

Third Hospital of the Air Force Medical University

Address：

145 Changle West Road, Xincheng District, Xi 'an City, Shaanxi Province

经费或物资来源：

专项课题

Source(s) of funding：

Special topics

Target disease：

Oral health and general frailty in the elderly

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：

横断面 

Study design：

Cross-sectional 

研究目的：

本课题在前期研究基础上，针对国内口腔与衰弱研究中的“三多一少”，立足课题组老年+口腔的学科优势，克服以往研究中口腔健康指标单一的不足，拟开展老年人群口腔健康与衰弱相关性的前瞻性研究，利用现场调查+问卷评估+口腔专科检查得到3年老年人群口腔健康和衰弱的动态变化，并借助多因素线性回归模型探讨各口腔健康要素与衰弱相关性，在此基础上使用PROCESS4.1 for SPSS结构方程模型分析营养、焦虑、认知减退和感染因素在口腔和全身衰弱之间的中介效应，以明确口腔健康导致衰弱的作用路径以及关键指标，为掌握我国国情背景下口腔与衰弱相关的动态轨迹，建立衰弱早期口腔预警模型，最终形成老年衰弱患者的口腔预防及干预方案提供理论依据。  

Objectives of Study：

On the basis of the previous research, this project aims at the "three more and one less" in the domestic oral and frailty research, based on the disciplinary advantages of the elderly + dentistry of the research group, and overcomes the shortcomings of the single oral health index in the previous research, and plans to carry out a prospective study on the correlation between oral health and frailty in the elderly population, and uses field survey + questionnaire evaluation + dental examination to obtain the dynamic changes of oral health and frailty in the elderly population in 3 years, and explores the correlation between each oral health element and frailty with the help of a multivariate linear regression model. On this basis, the PROCESS4.1 for SPSS structural equation model was used to analyze the mediating effects of nutrition, anxiety, cognitive decline and infectious factors between oral cavity and general frailty, so as to clarify the action path and key indicators of oral health leading to frailty, so as to provide a theoretical basis for grasping the dynamic trajectory of oral frailty related to oral frailty in the context of China's national conditions, establishing an early oral warning model for frailty, and finally forming an oral prevention and intervention program for elderly patients with frailty.

药物成份或治疗方案详述：

（1）结合文献，采用德尔菲法专家咨询法对研究方案进行函询，评价实验方案中各条目的可行性、适宜性、临床意义及有效性并做出推荐强度，最终形成实验方案。（已完成，评价结果见下表） 函询专家10名，包括老年医学专家3名，口腔医学专家4名，护理专家1名，统计学专家2名，各专家无任何利益相关，评分大于4.5分，提示审核结果较好。 （2）利用现况调查+问卷评估+口腔专科检查汇总老年人口腔健康状况和衰弱发生率，并进行口腔健康与衰弱的相关性分析。 ①　选取西北地区城市居住不同层次（社区，养老机构居民或医院门诊、住院）患者≥60岁老年人依据纳排标准选取研究对象，根据Fried量表评估全身衰弱情况并分组：正常、衰弱前、衰弱，收集研究对象人口和社会经济资料，进行口腔健康和功能检查评估，建立数据库，汇总资料，3年随访复查各指标纵向观察。 ②　以人口和社会经济资料、口腔健康和功能指标为自变量，衰弱为因变量进行logistic多因素分析，确定口腔健康指标与全身衰弱相关性，并对比分析3年口腔健康指标和衰弱状态变化以及二者相关分析结果。 （3）利用结构方程模型分析口腔健康对全身衰弱的直接和间接效应，并探讨营养、焦虑、认知减弱和感染中间变量在二者之间的作用。 ①　利用问卷调查营养、焦虑和认知减退状况，血清学检查感染炎症因子指标，建立数据库，汇总资料，3年随访复查各指标纵向观察。 ②　logistic多因素回归分别分析中介因素与口腔健康以及衰弱相关性，对比3年相关分析结果。 使用PROCESS4.1 for SPSS进行结构方程模型分析(中介效应分析)，验证营养、焦虑、认知减退和感染在口腔健康对衰弱作用中的中介效应，并对比3年分析结果。 

Description for medicine or protocol of treatment in detail：

(1) Combined with the literature, the Delphi method was used to consult the research protocol by expert consultation, and the feasibility, suitability, clinical significance and effectiveness of each item in the experimental protocol were evaluated, and the recommended intensity was made, and the experimental protocol was finally formed. (Completed, the results of the evaluation are shown in the table below) There were 10 experts consulted by letter, including 3 geriatric experts, 4 stomatology experts, 1 nursing expert, and 2 statistics experts, and the experts had no interest in each of them, and the score was greater than 4.5 points, indicating that the audit results were good. (2) The oral health status and incidence of frailty in the elderly were summarized by current situation survey + questionnaire evaluation + dental examination, and the correlation analysis between oral health and frailty was carried out. (1) Patients at different levels of urban residence (community, residents of nursing institutions or hospital outpatients and inpatients) in Northwest China were selected>= and the 60-year-old elderly were selected according to the inclusion criteria, and the general frailty was evaluated according to the Fried scale and grouped: normal, pre-frailty, and frailty, the demographic and socioeconomic data of the study subjects were collected, oral health and function examination and evaluation were carried out, a database was established, data were summarized, and longitudinal observation of each index was followed up for 3 years. (2) Logistic multivariate analysis was carried out with demographic and socioeconomic data, oral health and functional indicators as independent variables and frailty as dependent variables to determine the correlation between oral health indicators and general frailty, and the changes of oral health indicators and frailty in the past three years and the results of correlation analysis between the two were compared and analyzed. (3) Structural equation modeling was used to analyze the direct and indirect effects of oral health on general frailty, and to explore the role of intermediate variables of nutrition, anxiety, cognitive impairment and infection. (1) Questionnaires were used to investigate nutrition, anxiety and cognitive decline, serological examination of infection inflammatory factor indicators, database was established, data were summarized, and longitudinal observation of each index was re-examined after 3 years of follow-up; (2) Logistic multivariate regression analysis of the correlation between mediators and oral health and frailty was compared with the results of 3-year correlation analysis; Structural equation modelling (mediating effect analysis) was performed using PROCESS4.1 for SPSS to verify the mediating effects of nutrition, anxiety, cognitive decline, and infection in the effects of oral health on frailty, and the results of the three-year analysis were compared. 

纳入标准：

1)可完成老年综合评估； 2)自愿参加并签署知情同意书； 3)长期定居陕西等西北城市

Inclusion criteria

1) A comprehensive assessment of the elderly can be completed; 2) voluntarily participate and sign the informed consent form; 3) Long-term settlement in Shaanxi and other northwest cities.

排除标准：

1)严重慢性疾病或慢性疾病急性加重期，如：慢性阻塞性肺疾病急性加重期、慢性心力衰竭NYHA III-IV级、肾功能不全（eGFR＜15ml/1.73m^2·min或需要透析）、自身免疫性疾病急性活动期、正在接受治疗的肿瘤患者等； 2)急性重症疾病，如：重症肺炎、脓毒血症、下肢急性软组织感染、结核活动期、急性心力衰竭、急性肾功能衰竭、急性冠脉综合征、呼吸衰竭、急性脑卒中等； 3)长期卧床或完全失能； 4)无法配合完成相关体能检查，包括：握力、步行6米（可以使用手杖或助行器）、计时起立行走、平衡功能测试等； 5)终末期患者（预期寿命不足半年）； 6)患有严重心理精神疾病（如：严重抑郁症）； 7)严重的视力或听力障碍以至于妨碍日常交流，而无法完成调查表中的内容。

Exclusion criteria：

1) Severe chronic diseases or acute exacerbations of chronic diseases, such as: acute exacerbations of chronic obstructive pulmonary disease, chronic heart failure NYHA grade III-IV, renal insufficiency (eGFR<15ml/1.73m^2·min or requiring dialysis), acute active autoimmune diseases, tumor patients under treatment, etc.; 2) Acute severe diseases, such as: severe pneumonia, sepsis, acute soft tissue infection of the lower limbs, active tuberculosis, acute heart failure, acute renal failure, acute coronary syndrome, respiratory failure, acute stroke, etc.; 3) long-term bed rest or complete disability; 4) Inability to cooperate with the completion of relevant physical fitness examinations, including: grip strength, walking 6 meters (can use a cane or walker), timed stand-up walking, balance function test, etc.; 5) end-stage patients (life expectancy of less than half a year); 6) Suffering from severe mental and psychiatric illness (e.g., major depression); 7) Severe visual or hearing impairment that interferes with daily communication and is unable to complete the content of the questionnaire.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

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

干预措施：

Interventions：

组别：

观察组

样本量：

859

Group：

Observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

none

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

 西安市 

Country：

China 

Province：

Shaanxi Province 

City：

Xi 'an City 

单位(医院)：

空军军医大学第三附属医院 

单位级别：

三甲 

Institution
hospital：

Third Hospital of the Air Force Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

第四次口腔健康调查表

指标类型：

主要指标

Outcome：

Fourth Oral Health Questionnaire

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

EAT-10吞咽筛查

指标类型：

主要指标

Outcome：

EAT-10 swallowing screening

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

简易智能精神状态检查量表（MMSE）

指标类型：

主要指标

Outcome：

Mini-Mental State Examination (MMSE)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Fried 衰弱表型

指标类型：

主要指标

Outcome：

Fried's debilitating phenotype

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

营养风险筛查量表2002

指标类型：

主要指标

Outcome：

Nutritional Risk Screening 2002, NRS-2002

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑自评量表

指标类型：

主要指标

Outcome：

Self-Rating Anxiety Scale,SAS

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抑郁自评量表

指标类型：

主要指标

Outcome：

Self-Rating Depression Scale, SDS

Type：

Primary 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）：

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:

公开/Public

盲法：

无

Blinding：

None

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

Yes

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）：

2025-01-2027-12，有意者可联系研究者邮箱获取

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

2025-01-2027-12, Interested parties can contact the investigator's email address to obtain it

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：

病历记录表

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：

有/Yes

注册人：

Name of Registration：

  2024-12-20 16:17:00