ChiCTR2600123045 版本V1.0 版本创建时间2026/04/21 10:23:51 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:

ChiCTR2600123045 

最近更新日期:

Date of Last Refreshed on:

2026-04-21 10:23:39 

注册时间:

Date of Registration:

2026-04-21 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

基于行为经济学理论的老人疫苗接种助推策略开发、试验与评价:以流感疫苗为例

Public title:

Development, test and evaluation of vaccination boosting strategy for the elderly based on behavioral economics theory: taking influenza vaccine as an example

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于行为经济学理论的老人疫苗接种助推策略开发、试验与评价:以流感疫苗为例

Scientific title:

Development, test and evaluation of vaccination boosting strategy for the elderly based on behavioral economics theory: taking influenza vaccine as an example

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:

沙金婕 

研究负责人:

陈晨 

Applicant:

Sha Jinjie 

Study leader:

Chen Chen 

申请注册联系人电话:

Applicant telephone:

+86 133 1754 5577

研究负责人电话:

Study leader's
telephone:

+86 186 9617 0086

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:

2893888620@qq.com

研究负责人电子邮件:

Study leader's E-mail:

chenchen835@whu.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:

中国湖北省武汉市武昌区东湖路115号

研究负责人通讯地址:

中国湖北省武汉市武昌区东湖路115号

Applicant address:

115 Donghu Road, Wuchang District, Wuhan, Hubei, China

Study leader's address:

115 Donghu Road, Wuchang District, Wuhan, Hubei, China

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:

武汉大学

Applicant's institution:

Wuhan University

研究负责人所在单位:

武汉大学

Affiliation of the Leader:

Wuhan 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:

WHU-LFMD-IRB2025066

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:

武汉大学生命医学伦理委员会

Name of the ethic committee:

Wuhan University Biomedical Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2025-08-10 00:00:00

伦理委员会联系人:

刘珂

Contact Name of the ethic committee:

Liu Ke

伦理委员会联系地址:

中国湖北省武汉市武昌区东湖路115号

Contact Address of the ethic committee:

115 Donghu Road, Wuchang District, Wuhan, Hubei, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 27 6875 9329

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:

武汉大学

Primary sponsor:

Wuhan University

研究实施负责(组长)单位地址:

中国湖北省武汉市武昌区东湖路115号

Primary sponsor's address:

115 Donghu Road, Wuchang District, Wuhan, Hubei, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学

具体地址:

中国湖北省武汉市武昌区东湖路115号

Institution
hospital:

Wuhan University

Address:

115 Donghu Road, Wuchang District, Wuhan, Hubei, China

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation

研究疾病:

流行性感冒  

Target disease:

Influenza

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:

随机平行对照 

Study design:

Parallel 

研究目的:

试验有以下两个具体目的: 1)确定哪些助推策略在增加老人流感疫苗接种率方面是最有效的; 2)哪些助推策略在不同的亚组(基于年龄段、性别和居住地类型 )最有效。  

Objectives of Study:

The study has two specific objectives: 1)To identify which nudging strategies are most effective in increasing influenza vaccination rates among the elderly; 2)To determine which nudging strategies work best across different subgroups stratified by age group, gender, and type of residence.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

65 岁以上城乡地区老年人

Inclusion criteria

Elderly people aged 65 and above in urban and rural areas

排除标准:

1)医疗记录或自述对流感疫苗过敏或有不良反应者; 2)在随机对照分组开展之前已经接种过当前流感季的流感疫苗者; 3)已有家庭成员参与到该助推试验中的人(为避免家庭成员间的互相影响) 4)没有手机的人; 5)选择不接收短信的人。

Exclusion criteria:

1) Patients with medical records or self-reported allergies or adverse reactions to influenza vaccine; 2) Who received influenza vaccine in the current season before randomization; 3) People who already have family members participating in the nudge (to avoid family interactions) 4) People without mobile phones; 5) People who choose not to receive text messages.

研究实施时间:

Study execute time:

From 2025-08-18 00:00:00 To 2026-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-08-18 00:00:00 To 2025-10-14 00:00:00

干预措施:

Interventions:

组别:

控制组

样本量:

10100

Group:

Control group

Sample size:

干预措施:

(湖北省人民政府、武汉市疾控、社区卫生中心统一宣传形式)微信公众号、抖音平台、小区网格群信息(手机)、社区宣传(海报)。宣传结尾都有所有社区卫生中心的列表和电话,但是没有具体地址

干预措施代码:

Intervention:

Usual messages sent by Hubei Provincial Government, Wuhan CDC, and Community Health Centers unified promotion format sent through: tiktok, neighborhood WeChat groups, CDC wechat offical accounts .At the end of the announcement, all community health centers’ names and phone numbers are listed, but no specific addresses.

Intervention code:

组别:

干预组1(短信助推策略A)

样本量:

10100

Group:

Intervention Group 1(Boost strategy A)

Sample size:

干预措施:

老年人更易因流感出现严重并发症,接种流感疫苗可有效降低感染流感的风险,社区正提供【免费流感疫苗接种服务】。免费接种对象:65周岁及以上老年人(出生日期在1960年12月31日之前);接种单位:武汉经济技术开发区(汉南区)邓南街卫生院;接种地址:武汉市汉南区邓南街道水塔路20号;咨询电话:84740919。免费疫苗数量有限,先到先得,接种前请务必提前拨打咨询电话,避免跑空。(汉南区疾病预防控制中心)

干预措施代码:

Intervention:

Older adults are more likely to develop severe complications from influenza.Getting the flu vaccine can effectively reduce the risk of influenza infection. The community is providing [Free Influenza Vaccination Service].Free for: Adults aged 65 and above (born before Dec 31, 1960);Vaccination unit: Dengnan Street Health Center, Wuhan Economic & Technological Development Zone (Hannan District);Vaccination address: No. 20, Shuita Road, Dengnan Street, Hannan District, Wuhan City;Inquiry: 84740919.Free vaccine supply is limited and will be provided on a first-come, first-served basis. Please call in advance to avoid wasted trips. (Hannan CDC)

Intervention code:

组别:

干预组2(短信助推策略B)

样本量:

10100

Group:

Intervention Group 2(Boost strategy B)

Sample size:

干预措施:

老年人更易因流感出现严重并发症,一旦患病,免疫力下降并引发严重并发症,不仅会增加子女的照护负担,还可能将流感传染给家人。接种流感疫苗可有效降低感染流感的风险,社区正提供【免费流感疫苗接种服务】。免费接种对象:65周岁及以上老年人(出生日期在1960年12月31日之前);接种单位:武汉经济技术开发区(汉南区)邓南街卫生院;接种地址:武汉市汉南区邓南街道水塔路20号;咨询电话:84740919。免费疫苗数量有限,先到先得,接种前请务必提前拨打咨询电话,避免跑空。(汉南区疾病预防控制中心)

干预措施代码:

Intervention:

Older adults are more likely to develop severe complications from influenza.Once ill, immunity declines and serious complications may develop, not only increasing the caregiving burden for children but also potentially transmitting influenza to family members.Getting the flu vaccine can effectively reduce the risk of influenza infection. The community is providing [Free Influenza Vaccination Service].Free for: Adults aged 65 and above (born before Dec 31, 1960) Vaccination unit: Dengnan Street Health Center, Wuhan Economic & Technological Development Zone (Hannan District);Vaccination address: No. 20, Shuita Road, Dengnan Street, Hannan District, Wuhan City;Inquiry: 84740919.Free vaccine supply is limited and will be provided on a first-come, first-served basis. Please call in advance to avoid wasted trips. (Hannan CDC)

Intervention code:

组别:

干预组3(短信助推策略C)

样本量:

10100

Group:

Intervention Group 3(Boost strategy C)

Sample size:

干预措施:

“我以为只是感冒,结果住进了ICU。”流感不只是感冒,它可能引发【心力衰竭】、【肺炎】甚至【猝死】。流感导致的超额死亡病例中超过86%是≥65 岁老年人。老年人更易因流感出现严重并发症,接种流感疫苗可有效降低感染流感的风险,社区正提供【免费流感疫苗接种服务】。免费接种对象:65周岁及以上老年人(出生日期在1960年12月31日之前);接种单位:接种单位:武汉经济技术开发区(汉南区)邓南街卫生院;接种地址:武汉市汉南区邓南街道水塔路20号;咨询电话:84740919。免费疫苗数量有限,先到先得,接种前请务必提前拨打咨询电话,避免跑空。(汉南区疾病预防控制中心)

干预措施代码:

Intervention:

"I thought it was just a cold, but I ended up in the ICU." Influenza is not just a cold—it can cause [heart failure], [pneumonia], and even [sudden death]. More than 86% of excess mortality from influenza occurs among adults aged >=65 years.Older adults are more likely to develop severe complications from influenza.Getting the flu vaccine can effectively reduce the risk of influenza infection. The community is providing [Free Influenza Vaccination Service].Free for: Adults aged 65 and above (born before Dec 31, 1960);Vaccination unit: Dengnan Street Health Center, Wuhan Economic & Technological Development Zone (Hannan District) Vaccination address: No. 20, Shuita Road, Dengnan Street, Hannan District, Wuhan City;Inquiry : 84740919;Free vaccine supply is limited and will be provided on a first-come, first-served basis. Please call in advance to avoid wasted trips. (Hannan CDC)

Intervention code:

组别:

干预组4(短信助推策略D)

样本量:

10100

Group:

Intervention Group 4(Boost strategy D)

Sample size:

干预措施:

老年人接种【流感疫苗】不仅可有效预防流感,还能降低【心脏病发作】和【心力衰竭】等心血管疾病的发生风险。老年人更易因流感出现严重并发症,接种流感疫苗可有效降低感染流感的风险,社区正提供【免费流感疫苗接种服务】。 免费接种对象:65周岁及以上老年人(出生日期在1960年12月31日之前) 接种单位:接种单位:武汉经济技术开发区(汉南区)邓南街卫生院 接种地址:武汉市汉南区邓南街道水塔路20号 咨询电话:84740919 免费疫苗数量有限,先到先得,接种前请务必提前拨打咨询电话,避免跑空。(汉南区疾病预防控制中心)

干预措施代码:

Intervention:

Older adults receiving [influenza vaccination] can not only effectively prevent influenza but also reduce the risk of cardiovascular diseases such as [heart attack] and [heart failure].Older adults are more likely to develop severe complications from influenza. Getting the flu vaccine can effectively reduce the risk of influenza infection. The community is providing [Free Influenza Vaccination Service]. Free for: Adults aged 65 and above (born before Dec 31, 1960) Vaccination unit: Dengnan Street Health Center, Wuhan Economic & Technological Development Zone (Hannan District) Vaccination address: No. 20, Shuita Road, Dengnan Street, Hannan District, Wuhan City Inquiry: 84740919 Free vaccine supply is limited and will be provided on a first-come, first-served basis. Please call in advance to avoid wasted trips. (Hannan CDC)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

洪山区德康老年病医院 

单位级别:

二级 

Institution
hospital:

Dekang Geriatric hospital, Hongshan District

Level of the institution:

Secondary

国家:

中国

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

经济技术开发区(汉南区)疾病预防控制中心 

单位级别:

无 

Institution
hospital:

Economic and Technological Development Zone (Hannan District) Center for Disease Control and Prevention

Level of the institution:

N/A

国家:

中国

省(直辖市):

浙江 

市(区县):

宁波 

Country:

China

Province:

Zhejiang

City:

Ningbo

单位(医院):

鄞州区疾病预防控制中心 

单位级别:

无 

Institution
hospital:

Yinzhou district disease prevention control center

Level of the institution:

N/A

国家:

中国

省(直辖市):

四川 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

武侯区疾病预防与控制中心 

单位级别:

无 

Institution
hospital:

Wuhou District Center for Disease Prevention and Control

Level of the institution:

N/A

国家:

中国

省(直辖市):

四川 

市(区县):

 

Country:

China

Province:

Sichuan

City:

单位(医院):

郫都区疾病预防与控制中心 

单位级别:

无 

Institution
hospital:

Pidu District Center for Disease Prevention and Control

Level of the institution:

N/A

测量指标:

Outcomes:

指标中文名:

参与者是否在试验开展的流感季接种了流感疫苗

指标类型:

主要指标

Outcome:

Whether the participants received the flu vaccine during the flu season when the trial was conducted

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

参与者是否愿意在下一个流感季接种流感疫苗

指标类型:

次要指标

Outcome:

Participants are willing to get the flu vaccine in the next flu season or not.

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:

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:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 65 years
最大 Max age 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):

研究人员采用随机数表法产生随机序列,将老年人随机分配到试验组或对照组。

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

The researchers used the random number table method to generate random sequences and randomly assigned the elderly to the experimental group or the control group.

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:

单盲试验,不向受试者披露分组结果

Blinding:

Single blind trial, without disclosing the grouping results to the subjects.

是否共享原始数据:

IPD sharing

是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):

试验结束后6个月内上传数据,共享平台:resman

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

Data were uploaded within 6 months after the end of the trial and shared on resman

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:

数据来源于各研究地区疾病预防与控制中心信息系统,相关数据由疾病预防控制中心工作人员进行管理。数据分析时会进行脱敏处理,形成不含隐私信息的分析数据集。本研究最终分析时所使用的数据为去除个人敏感信息后的不可识别数据。如有需要,可联系研究负责人邮箱chenchen835@whu.edu.cn

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

Data were obtained from the information systems of the CDC in the respective study areas, and managed by CDC staff.Data were de-identified during data analysis to form an analytical dataset free of private information.The data used in the final analysis of this study were non-identifiable data with personal sensitive information removed.If needed, you can contact the research supervisor at chenchen835@whu.edu.cn.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-04-21 10:23:39