ChiCTR2600116510 版本V1.0 版本创建时间2026/01/12 10:44:48 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:

ChiCTR2600116510 

最近更新日期:

Date of Last Refreshed on:

2026-01-12 10:44:42 

注册时间:

Date of Registration:

2026-01-12 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于离散选择实验的PRISm人群戒烟行为选择偏好研究

Public title:

Preferences for Smoking Cessation Behaviors Among PRISm Populations: A Discrete Choice Experiment Approach

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于离散选择实验的PRISm人群戒烟行为选择偏好研究——以天津市为例

Scientific title:

Discrete Choice Experiment on Smoking Cessation Preferences in PRISm Population: Evidence from Tianjin, China

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:

刘欣怡 

研究负责人:

王岚 

Applicant:

Liu Xinyi 

Study leader:

Wang Lan 

申请注册联系人电话:

Applicant telephone:

+86 183 4213 3079

研究负责人电话:

Study leader's
telephone:

+86 138 2126 9307

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:

liuxinyi3079@163.com

研究负责人电子邮件:

Study leader's E-mail:

wangl0423@tmu.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:

中国天津市和平区气象台路22号

研究负责人通讯地址:

中国天津市和平区气象台路22号

Applicant address:

No. 22 Meteoriantai Road, Heping District, Tianjin, China

Study leader's address:

No. 22 Meteoriantai Road, Heping District, Tianjin, 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:

天津医科大学

Applicant's institution:

Tianjin Medical University

研究负责人所在单位:

天津医科大学

Affiliation of the Leader:

Tianjin Medical 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:

TMUhMEC20250017

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:

天津医科大学伦理委员会

Name of the ethic committee:

Ethics Committee of Tianjin Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-07-07 00:00:00

伦理委员会联系人:

刘欣怡

Contact Name of the ethic committee:

Liu Xinyi

伦理委员会联系地址:

中国天津市和平区气象台路22号

Contact Address of the ethic committee:

No. 22 Meteoriantai Road, Heping District, Tianjin, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 153 8393 8790

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:

天津医科大学

Primary sponsor:

Tianjin Medical University

研究实施负责(组长)单位地址:

中国天津市和平区气象台路22号

Primary sponsor's address:

No. 22 Meteoriantai Road, Heping District, Tianjin, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津医科大学

具体地址:

中国天津市和平区气象台路22号

Institution
hospital:

Tianjin Medical University

Address:

No. 22 Meteoriantai Road, Heping District, Tianjin, China

经费或物资来源:

Source(s) of funding:

None

研究疾病:

慢性阻塞性肺疾病  

Target disease:

Chronic obstructive pulmonary disease

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:

横断面 

Study design:

Cross-sectional 

研究目的:

吸烟作为COPD发生发展的重要独立危险因素,推动慢阻肺前期患者特别是 PRISm 人群戒烟具有重要的临床价值和社会意义。本研究旨在通过离散选择实验量化PRISm人群对戒烟方案各属性及水平的行为需求现状和偏好权重,估计PRISm人群对戒烟行为的支付意愿及偏好异质性,以期为制定精准戒烟策略提供依据和改善建议。  

Objectives of Study:

Smoking serves as a significant independent risk factor for the onset and progression of COPD. Promoting smoking cessation among individuals in the pre-COPD stage, particularly the PRISm population, holds substantial clinical value and societal significance. This study aims to quantify the behavioral demand and preference weights for various attributes and levels of smoking cessation programs among the PRISm population through a discrete choice experiment. It further estimates the willingness to pay for smoking cessation behaviors and preference heterogeneity within this group, thereby providing evidence and improvement recommendations for developing targeted smoking cessation strategies.

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.肺功能检测指标显示FEV1/FVC≥0.7但FEV1%pred<80%; 2.当前吸烟或一生中连续或累计吸烟≥6个月; 3.年龄≥18岁; 4.有认知能力,能独立或在指导下完成问卷填写并自愿参与本研究。

Inclusion criteria

1. Pulmonary function test results show FEV1/FVC >= 0.7 but FEV1%pred < 80%; 2. Current smoker or lifetime continuous or cumulative smoking >= 6 months; 3. Age >=18 years; 4. Possesses cognitive ability to complete questionnaires independently or with guidance and voluntarily participates in this study.

排除标准:

1.存在听力障碍; 2.合并其他严重、恶性疾病,无法参加本研究者; 3.经沟通拒绝参加本研究者。

Exclusion criteria:

1. Presence of hearing impairment; 2. Concurrent severe or malignant diseases, unable to participate in this study; 3. Refusal to participate in this study after communication.

研究实施时间:

Study execute time:

From 2025-09-01 00:00:00 To 2028-12-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-01-15 00:00:00 To 2028-12-31 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

225

Group:

Observation group

Sample size:

干预措施:

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):

天津 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市和平区新兴街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Xinxing Street Community Health Service Center, Heping District, Tianjin

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

天津 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市南开区体育中心街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Tianjin Nankai District Sports Center Street Community Health Service Center

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

天津 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市河北区王串场街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Wangchuanchang Street Community Health Service Center, Hebei District, Tianjin

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

天津 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市红桥区咸阳北路街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Xianyang North Road Street Community Health Service Center, Hongqiao District, Tianjin

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

天津 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市河西区尖山街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Jianshan Street Community Health Service Center, Hexi District, Tianjin

Level of the institution:

Community Health Service Center

国家:

中国

省(直辖市):

天津 

市(区县):

 

Country:

China

Province:

Tianjin

City:

单位(医院):

天津市河东区大直沽街社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Hedong District Dazhigu Street Community Health Service Center, Tianjin

Level of the institution:

Community Health Service Center

测量指标:

Outcomes:

指标中文名:

PRISm患者戒烟行为选择属性和水平偏好

指标类型:

主要指标

Outcome:

Smoking Cessation Behavior Choices and Preference Levels in PRISm Patients

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

PRISm人群对戒烟行为的支付意愿及偏好异质性

指标类型:

次要指标

Outcome:

Willingness to Pay and Preference Heterogeneity for Smoking Cessation among PRISm Population

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:

None

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

None

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 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):

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:

Blinding:

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

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):

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:

病例记录表

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:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-01-12 10:44:42