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中国男性吸烟者戒烟应用软件的预试验
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注册号：

Registration number：

 ChiCTR1800020434 

最近更新日期：

Date of Last Refreshed on：

 2018-12-29 19:34:19 

注册时间：

Date of Registration：

 2018-12-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

中国男性吸烟者戒烟应用软件的预试验

Public title：

Smoking Cessation App for (Chinese) Male smokers: Pilot Intervention trial

注册题目简写：

English Acronym：

SCAMPI

研究课题的正式科学名称：

中国男性吸烟者戒烟应用软件的预试验

Scientific title：

Smoking Cessation App for (Chinese) Male smokers: Pilot Intervention trial

研究课题代号(代码)：

Study subject ID：

 375381

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：

Australian New Zealand Clinical Trial Registry

申请注册联系人：

Jinsong Chen 

研究负责人：

Professor Chris Bullen 

Applicant：

Jinsong Chen 

Study leader：

Professor Chris Bullen 

申请注册联系人电话：

Applicant telephone：

 +64 022 0 951065

研究负责人电话：

Study leader's
telephone：

+64 0 21415267

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：

 jinsong.chen@auckland.ac.nz

研究负责人电子邮件：

Study leader's E-mail：

 c.bullen@auckland.ac.nz

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：

261 Morrin Rd, St Johns, Auckland, New Zealand

研究负责人通讯地址：

261 Morrin Rd, St Johns, Auckland, New Zealand

Applicant address：

261 Morrin Rd, St Johns, Auckland, New Zealand

Study leader's address：

261 Morrin Rd, St Johns, Auckland, New Zealand

申请注册联系人邮政编码：

Applicant postcode：

 1072

研究负责人邮政编码：

Study leader's postcode：

 1072

申请人所在单位：

National Institute for Health Innovation

Applicant's institution：

National Institute for Health Innovation

研究负责人所在单位：

National Institute for Health Innovation

Affiliation of the Leader：

National Institute for Health Innovation

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2

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：

University of Auckland Human Participants Ethics Committee (UAHPEC)

Name of the ethic committee：

University of Auckland Human Participants Ethics Committee (UAHPEC)

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-12-21 00:00:00

伦理委员会联系人：

UAHPEC Administrators

Contact Name of the ethic committee：

UAHPEC Administrators

伦理委员会联系地址：

261 Morrin Rd, St Johns, Auckland, New Zealand

Contact Address of the ethic committee：

261 Morrin Rd, St Johns, Auckland, New Zealand

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

新西兰奥克兰大学

Primary sponsor：

University of Auckland

研究实施负责（组长）单位地址：

261 Morrin Rd, St Johns, Auckland, New Zealand

Primary sponsor's address：

261 Morrin Rd, St Johns, Auckland, New Zealand

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Student PReSS Account

Source(s) of funding：

Student PReSS Account

研究疾病：

吸烟  

Target disease：

Smoking

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：

This project evaluates smartphone app-based smoking cessation programme, called as SCAMPI, which consists of a social network subscription account (SCAMPI WeChat Official Account) and a social network based app (SCAMPI mini-programme). The SCAMPI programme was developed based on the preferred features (functions, user experience and user interface) of its target end-users (Chinese male smokers aged 25 to 44 years). This project will be implemented fully online. The evaluation will be run as a pilot two-arm randomised controlled trial (RCT). After providing e-consents, participants will be randomly allocated to two groups. Participants allocated to intervention group will be offered the full version of SCAMPI programme (6 weeks intervention) while participants allocated to control group will be offered with restricted version of SCAMPI programme, which provides contact to general Chinese smoking cessation care (including Chinese Quitline and Local smoking cessation clinics). Smoking status of participants from both groups will be measured weekly over a 6-week period. Participants' 30-day bio-verified smoking abstinence will be used to assess the preliminary effectiveness of the SCAMPI programme for helping people to quit smoking. At the end of the project, participants will be asked about their satisfaction levels with the SCAMPI programme. Participants from both groups will be offered the SCAMPI programme with free-of-charge for supporting them to quit smoking after the study complete.  

Objectives of Study：

This project evaluates smartphone app-based smoking cessation programme, called as SCAMPI, which consists of a social network subscription account (SCAMPI WeChat Official Account) and a social network based app (SCAMPI mini-programme). The SCAMPI programme was developed based on the preferred features (functions, user experience and user interface) of its target end-users (Chinese male smokers aged 25 to 44 years). This project will be implemented fully online. The evaluation will be run as a pilot two-arm randomised controlled trial (RCT). After providing e-consents, participants will be randomly allocated to two groups. Participants allocated to intervention group will be offered the full version of SCAMPI programme (6 weeks intervention) while participants allocated to control group will be offered with restricted version of SCAMPI programme, which provides contact to general Chinese smoking cessation care (including Chinese Quitline and Local smoking cessation clinics). Smoking status of participants from both groups will be measured weekly over a 6-week period. Participants' 30-day bio-verified smoking abstinence will be used to assess the preliminary effectiveness of the SCAMPI programme for helping people to quit smoking. At the end of the project, participants will be asked about their satisfaction levels with the SCAMPI programme. Participants from both groups will be offered the SCAMPI programme with free-of-charge for supporting them to quit smoking after the study complete.

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：

Nil

Exclusion criteria：

Nil

研究实施时间：

Study execute time：

从 From 2019-01-01 00:00:00至 To 2019-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-01-01 00:00:00 至 To 2019-03-01 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 40

Group：

Group 1

Sample size：

干预措施：

Full version SCAMPI smoking cessation programme

干预措施代码：

Intervention：

Full version SCAMPI smoking cessation programme

Intervention code：

组别：

Group 2

样本量：

 40

Group：

Group 2

Sample size：

干预措施：

Restricted version SCAMPI smoking cessation programme

干预措施代码：

Intervention：

Restricted version SCAMPI smoking cessation programme

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 新西兰

省(直辖市)：

 奥克兰 

市(区县)：

  

Country：

New Zealand

Province：

Auckland

City：

单位(医院)：

 奥克兰大学 

单位级别：

 大学 

Institution
hospital：

University of Auckland

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

30-day bio-verified smoking abstinence

指标类型：

主要指标

Outcome：

30-day bio-verified smoking abstinence

Type：

Primary indicator

测量时间点：

Assessed weekly after randomisation for 6 weeks

测量方法：

self-reported and saliva test through sending results by social network

Measure time point of outcome：

Assessed weekly after randomisation for 6 weeks

Measure method：

self-reported and saliva test through sending results by social network

指标中文名：

reduction in cigarette consumption

指标类型：

次要指标

Outcome：

reduction in cigarette consumption

Type：

Secondary indicator

测量时间点：

Assessed weekly after randomisation for 6 weeks

测量方法：

self-reported through social network

Measure time point of outcome：

Assessed weekly after randomisation for 6 weeks

Measure method：

self-reported through social network

指标中文名：

prolonged smoking abstinence

指标类型：

次要指标

Outcome：

prolonged smoking abstinence

Type：

Secondary indicator

测量时间点：

Assessed weekly after randomisation for 6 weeks

测量方法：

self-reported through social network

Measure time point of outcome：

Assessed weekly after randomisation for 6 weeks

Measure method：

self-reported through social network

指标中文名：

7-day smoking abstinence

指标类型：

次要指标

Outcome：

7-day smoking abstinence

Type：

Secondary indicator

测量时间点：

Assessed at 4-week and 6-week time point after randomisation

测量方法：

self-reported through social network

Measure time point of outcome：

Assessed at 4-week and 6-week time point after randomisation

Measure method：

self-reported through social network

指标中文名：

30-day smoking abstinence

指标类型：

次要指标

Outcome：

30-day smoking abstinence

Type：

Secondary indicator

测量时间点：

Assessed weekly after randomisation for 6 weeks

测量方法：

self-reported through social network

Measure time point of outcome：

Assessed weekly after randomisation for 6 weeks

Measure method：

self-reported through social network

指标中文名：

compliance with intervention

指标类型：

次要指标

Outcome：

compliance with intervention

Type：

Secondary indicator

测量时间点：

Assessed weekly after randomisation for 6 weeks

测量方法：

self-reported through social network

Measure time point of outcome：

Assessed weekly after randomisation for 6 weeks

Measure method：

self-reported through social network

指标中文名：

Number of times using intervention

指标类型：

次要指标

Outcome：

Number of times using intervention

Type：

Secondary indicator

测量时间点：

Assessed weekly after randomisation for 6 weeks

测量方法：

self-reported through social network

Measure time point of outcome：

Assessed weekly after randomisation for 6 weeks

Measure method：

self-reported through social network

指标中文名：

acceptability of using the programme as smoking cessation intervention

指标类型：

次要指标

Outcome：

acceptability of using the programme as smoking cessation intervention

Type：

Secondary indicator

测量时间点：

Assessed at the end of the trial

测量方法：

questionnaire

Measure time point of outcome：

Assessed at the end of the trial

Measure method：

questionnaire

指标中文名：

satisfaction of using the programme as smoking cessation intervention

指标类型：

次要指标

Outcome：

satisfaction of using the programme as smoking cessation intervention

Type：

Secondary indicator

测量时间点：

Assessed at the end of the trial

测量方法：

questionnaire

Measure time point of outcome：

Assessed at the end of the trial

Measure method：

questionnaire

采集人体标本：

Collecting sample(s)
from participants：

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 25 岁 years
最大 Max age 44 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

The randomisation sequence will be generated by the trial statistician using block randomisation with variable block sizes of 2 or 4.

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

The randomisation sequence will be generated by the trial statistician using block randomisation with variable block sizes of 2 or 4.

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：

未说明

Blinding：

Not stated

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

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）：

Individual participants are not identifiable from the data. The collected data will be kept in confidential.

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

Individual participants are not identifiable from the data. The collected data will be kept in confidential.

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：

Data Collection: Data from this pilot trial will be extracted from three different sources: (1) the WeChat OA control panel for the data in related to the SCAMPI OA usage; (2) Wenjuanxin (it is an online questionnaire that is embed into WeChat OA system) control panel for the data in related to baseline assessment and weekly smoking status; and (3) the lean cloud database for the data in related to SCAMPI mini-programme usage. Extracted data will be entered into an Excel Database, and following cleaning and datalock, exported into SAS (version 9.4) for analysis. Baseline characteristics Baseline data collected from all participants will be summarised by occasional smoker and daily smoker. Continuous variables (e.g. average daily cigarette consumption) will be presented as numbers observed, means and standard deviations. Categorical variables (e.g. marital status) will be presented as frequencies and percentages. Since any differences between randomised groups at baseline could only have occurred by chance, no formal significance testing will be conducted. Outcome relevant data Primary and secondary outcomes will be first summarised descriptively at identified time points. Generalised linear mixed model will be used to assess the effect of the SCAMPI programme to participants’ smoking cessation outcomes. Data Management: The data collected from the SCAMPI programme will be directly exported from different servers and purged. Researchers will review all the data in China and convert these data and data findings into secondary data for analysis purposes. Access to all study data will be restricted to research staff directly involved in conducting or monitoring the study. Confidentiality will be protected by the use of study registration numbers, and only aggregated and anonymous data will be reported. No personal information will be collected. Computerised information will be password protected and hard copy information kept in a locked filing cabinet. All reports from the study will be written in a way such that no individuals can be identified.

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

Data Collection: Data from this pilot trial will be extracted from three different sources: (1) the WeChat OA control panel for the data in related to the SCAMPI OA usage; (2) Wenjuanxin (it is an online questionnaire that is embed into WeChat OA system) control panel for the data in related to baseline assessment and weekly smoking status; and (3) the lean cloud database for the data in related to SCAMPI mini-programme usage. Extracted data will be entered into an Excel Database, and following cleaning and datalock, exported into SAS (version 9.4) for analysis. Baseline characteristics Baseline data collected from all participants will be summarised by occasional smoker and daily smoker. Continuous variables (e.g. average daily cigarette consumption) will be presented as numbers observed, means and standard deviations. Categorical variables (e.g. marital status) will be presented as frequencies and percentages. Since any differences between randomised groups at baseline could only have occurred by chance, no formal significance testing will be conducted. Outcome relevant data Primary and secondary outcomes will be first summarised descriptively at identified time points. Generalised linear mixed model will be used to assess the effect of the SCAMPI programme to participants’ smoking cessation outcomes. Data Management: The data collected from the SCAMPI programme will be directly exported from different servers and purged. Researchers will review all the data in China and convert these data and data findings into secondary data for analysis purposes. Access to all study data will be restricted to research staff directly involved in conducting or monitoring the study. Confidentiality will be protected by the use of study registration numbers, and only aggregated and anonymous data will be reported. No personal information will be collected. Computerised information will be password protected and hard copy information kept in a locked filing cabinet. All reports from the study will be written in a way such that no individuals can be identified.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2018-12-29 19:34:19
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