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Effectiveness of a mhealth Intervention for Increasing Colonoscopy Uptake among Chinese First-degree Relatives of People with Colorectal Cancer
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注册号：

Registration number：

 ChiCTR1900020656 

最近更新日期：

Date of Last Refreshed on：

 2019-01-12 08:15:13 

注册时间：

Date of Registration：

 2019-01-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effectiveness of a mhealth Intervention for Increasing Colonoscopy Uptake among Chinese First-degree Relatives of People with Colorectal Cancer

Public title：

Effectiveness of a mhealth Intervention for Increasing Colonoscopy Uptake among Chinese First-degree Relatives of People with Colorectal Cancer

注册题目简写：

English Acronym：

Effectiveness of a mhealth intervention

研究课题的正式科学名称：

Effectiveness of a mhealth Intervention for Increasing Colonoscopy Uptake among Chinese First-degree Relatives of People with Colorectal Cancer

Scientific title：

Effectiveness of a mhealth Intervention for Increasing Colonoscopy Uptake among Chinese First-degree Relatives of People with Colorectal Cancer

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：

白杨 

研究负责人：

白杨 

Applicant：

Bai Yang 

Study leader：

Bai Yang 

申请注册联系人电话：

Applicant telephone：

 +86 13510215428

研究负责人电话：

Study leader's
telephone：

+86 13510215428

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：

 april666@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 april666@link.cuhk.edu.hk

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：

中國香港特別行政區新界沙田香港中文大學利黃瑤璧樓

研究负责人通讯地址：

中國香港特別行政區新界沙田香港中文大學利黃瑤璧樓

Applicant address：

6/F Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SR, China

Study leader's address：

6/F Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

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：

香港中文大學

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Chinese University of Hong Kong

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：

 2018.368

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：

香港中文大學-新界地區聯合臨床研究倫理委員會

Name of the ethic committee：

Joint Chinese Univeristy of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-11-09 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾斯親王醫院呂志和臨床科學大樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35052144

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：

香港中文大學醫學院那打素護理學院

Primary sponsor：

The Nethersole school of nursing, Chinese University of Hong Kong

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田香港中文大學利黃瑤璧樓

Primary sponsor's address：

6/F Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

NA

研究疾病：

結直腸癌  

Target disease：

Colorectal Cancer

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：

 卫生服务研究 

Study phase：

Health Services Research

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study aims to develop a tailored risk communication intervention (TRCI) based on results of the systematic review on interventions to promote colonoscopy screening conducted by the principal investigator, and examine its effectiveness in promoting colonoscopy uptake among Chinese first-degree relatives (FDRs).  

Objectives of Study：

This study aims to develop a tailored risk communication intervention (TRCI) based on results of the systematic review on interventions to promote colonoscopy screening conducted by the principal investigator, and examine its effectiveness in promoting colonoscopy uptake among Chinese first-degree relatives (FDRs).

药物成份或治疗方案详述：

Participants in intervention group will receive a theoretically based communication intervention consisting of three sessions: (1) session one will be a web link sent through We-chat to complete personal assessment and deliver tailored messages; (2) session two is a We-chat voice counseling call to help further understand the tailored messages regarding Colorectal cancer and screening recommendations; (3) Session three is a leaflet sent through We-chat that summarized the key messages. 

Description for medicine or protocol of treatment in detail：

Participants in intervention group will receive a theoretically based communication intervention consisting of three sessions: (1) session one will be a web link sent through We-chat to complete personal assessment and deliver tailored messages; (2) session two is a We-chat voice counseling call to help further understand the tailored messages regarding Colorectal cancer and screening recommendations; (3) Session three is a leaflet sent through We-chat that summarized the key messages. 

纳入标准：

Inclusion criteria

排除标准：

(1) have history of cancer or inflammatory bowel disease;
(2) recently participate in another study or previously participated in cancer risk counseling or study;
(3) with doctor-diagnosed psychiatric illness.

Exclusion criteria：

(1) have history of cancer or inflammatory bowel disease;
(2) recently participate in another study or previously participated in cancer risk counseling or study;
(3) with doctor-diagnosed psychiatric illness.

研究实施时间：

Study execute time：

从 From 2019-03-04 00:00:00至 To 2019-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-03-04 00:00:00 至 To 2019-05-31 00:00:00

干预措施：

Interventions：

组别：

Intervention

样本量：

 105

Group：

Intervention

Sample size：

干预措施：

Tailored communication intervention

干预措施代码：

Intervention：

Tailored communication intervention

Intervention code：

组别：

Control

样本量：

 105

Group：

Control

Sample size：

干预措施：

Usual care

干预措施代码：

Intervention：

Usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangzhou

City：

Shenzhen

单位(医院)：

 深圳市南山区人民医院 

单位级别：

 三甲医院 

Institution
hospital：

Shenzhen Nanshan District Chronic Disease Center

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

Colonoscopy screening rate

指标类型：

主要指标

Outcome：

Colonoscopy screening rate

Type：

Primary indicator

测量时间点：

Baseline, one month and three month after the intervention

测量方法：

Colonoscopy medical records

Measure time point of outcome：

Baseline, one month and three month after the intervention

Measure method：

Colonoscopy medical records

指标中文名：

Perceived susceptibility

指标类型：

次要指标

Outcome：

Perceived susceptibility

Type：

Secondary indicator

测量时间点：

Baseline, one month and three month after the intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, one month and three month after the intervention

Measure method：

Questionnaire

指标中文名：

Perceived severity

指标类型：

次要指标

Outcome：

Perceived severity

Type：

Secondary indicator

测量时间点：

Baseline, one month and three month after the intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, one month and three month after the intervention

Measure method：

Questionnaire

指标中文名：

Perceived barriers

指标类型：

次要指标

Outcome：

Perceived barriers

Type：

Secondary indicator

测量时间点：

Baseline, one month and three month after the intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, one month and three month after the intervention

Measure method：

Questionnaire

指标中文名：

Perceived benefits

指标类型：

次要指标

Outcome：

Perceived benefits

Type：

Secondary indicator

测量时间点：

Baseline, one month and three month after the intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, one month and three month after the intervention

Measure method：

Questionnaire

指标中文名：

Self-efficacy

指标类型：

次要指标

Outcome：

Self-efficacy

Type：

Secondary indicator

测量时间点：

Baseline, one month and three month after the intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, one month and three month after the intervention

Measure method：

Questionnaire

指标中文名：

Cue to action

指标类型：

次要指标

Outcome：

Cue to action

Type：

Secondary indicator

测量时间点：

Baseline, one month and three month after the intervention

测量方法：

Questionnaire

Measure time point of outcome：

Baseline, one month and three month after the intervention

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 岁 years
最大 Max age 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）：

Each family will be randomly assigned to TRSI group or control group with a 1:1 ratio using a sequence of block randomization number to assign cluster numbers equally to each group. A statistician will generates a random number sequence by computer software, a randomly mixed block size at 4-8 will b

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

Each family will be randomly assigned to TRSI group or control group with a 1:1 ratio using a sequence of block randomization number to assign cluster numbers equally to each group. A statistician will generates a random number sequence by computer software, a randomly mixed block size at 4-8 will b

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：

Due to the nature of the intervention, blinding of participants and researchers is impossible. To avoid biased estimated of treatment effect, online survey will be conducted.?Participant will submit the web form back to the web server directly when the finish the assessment and the intervener are not able to influence the assessment.

Blinding：

Due to the nature of the intervention, blinding of participants and researchers is impossible. To avoid biased estimated of treatment effect, online survey will be conducted. Participant will submit the web form back to the web server directly when the finish the assessment and the personnel are not able to influence the assessment.

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）：

Publication

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

Publication

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：

All research-related documents and data will be carefully kept and locked in a secured cabinet and password protected computer, and only accessed by the PI. All documents would be completely destroyed five years after completion of the research project.

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

All research-related documents and data will be carefully kept and locked in a secured cabinet and password protected computer, and only accessed by the PI. All documents would be completely destroyed five years after completion of the research project.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2019-01-12 08:15:13
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