ChiCTR2000039791 版本V1.3 版本创建时间2024/07/23 15:35:23 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：

ChiCTR2000039791 

最近更新日期：

Date of Last Refreshed on：

2024-07-23 09:59:10 

注册时间：

Date of Registration：

2020-11-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Increasing rotavirus vaccine uptake: a randomised controlled trial

Public title：

Increasing rotavirus vaccine uptake: a randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Increasing rotavirus vaccine uptake: a randomised controlled trial

Scientific title：

Increasing rotavirus vaccine uptake: a randomised controlled trial

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：

Leung Hiu Yan Christine 

研究负责人：

Tony Nelson 

Applicant：

Leung Hiu Yan Christine 

Study leader：

Tony Nelson 

申请注册联系人电话：

Applicant telephone：

+852 93091652

研究负责人电话：

Study leader's telephone：

+852 35052861

申请注册联系人传真 ：

Applicant Fax：

+852 26360020

研究负责人传真：

Study leader's fax：

+852 26360020

申请注册联系人电子邮件：

Applicant E-mail：

christine@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

tony-nelson@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：

6/F, Department of Paediatrics, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

研究负责人通讯地址：

6/F, Department of Paediatrics, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

Applicant address：

6/F, Department of Paediatrics, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

Study leader's address：

6/F, Department of Paediatrics, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

852

研究负责人邮政编码：

Study leader's postcode：

852

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

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：

2019.718-T; KC/KE-20-0010/ER-2; 2019.718-T(2023.02.17修正案); KC/KE-20-0010/ER-2(2023.04.14修正案)

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-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee; Research Ethics Committee (Kowloon Central / Kowloon East)

伦理委员会批准日期：

Date of approved by ethic committee：

2020-02-19 00:00:00

伦理委员会联系人：

Ms Jenny Ng; Dr Winnie Chan

Contact Name of the ethic committee：

Ms Jenny Ng; Dr Winnie Chan

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong; Room 808, Block S, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong; Room 808, Block S, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3505 3874

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：

Nil

Primary sponsor：

Nil

研究实施负责（组长）单位地址：

Nil

Primary sponsor's address：

Nil

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Not stated

省(直辖市)：

Not stated

市(区县)：

Country：

Not stated

Province：

Not stated

City：

单位(医院)：

Not stated

具体地址：

Not stated

Institution
hospital：

Not stated

Address：

Not stated

经费或物资来源：

Health and Medical Research Fund (HMRF)

Source(s) of funding：

Health and Medical Research Fund (HMRF)

Target disease：

Rotavirus

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：

1. To determine whether removal of financial barriers can increase uptake of rotavirus vaccine in children. 2. To determine whether provision of key information on rotavirus infection and vaccination can increase uptake of rotavirus vaccine in children.  

Objectives of Study：

1. To determine whether removal of financial barriers can increase uptake of rotavirus vaccine in children. 2. To determine whether provision of key information on rotavirus infection and vaccination can increase uptake of rotavirus vaccine in children.

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. Postpartum mothers from the study hospitals; 2. Aged older than 18 years; 3. Cantonese speaking and able to read traditional Chinese; 4. Have a plan to remain in Hong Kong with the infant after delivery for at least 8 months (upper age limit for giving rotavirus vaccine according to product information); 5. No obvious cognitive abnormality; 6. No serious obstetrical complications and baby is full-term (>=37 weeks of gestation) with no congenital abnormalities; and 7. Can provide signed informed consent.

Inclusion criteria

1. Postpartum mothers from the study hospitals; 2. Aged older than 18 years; 3. Cantonese speaking and able to read traditional Chinese; 4. Have a plan to remain in Hong Kong with the infant after delivery for at least 8 months (upper age limit for giving rotavirus vaccine according to product information); 5. No obvious cognitive abnormality; 6. No serious obstetrical complications and baby is full-term (>=37 weeks of gestation) with no congenital abnormalities; and 7. Can provide signed informed consent.

排除标准：

Subjects who cannot meet the inclusion criteria would be excluded.

Exclusion criteria：

Subjects who cannot meet the inclusion criteria would be excluded.

研究实施时间：

Study execute time：

从 From 2020-10-05 00:00:00至 To 2023-04-04 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-02-16 00:00:00 至 To 2021-07-30 00:00:00  

干预措施：

Interventions：

组别：

Control Group

样本量：

263

Group：

Control Group

Sample size：

干预措施：

Publicly available information from the Centre for Health Protection (CHP) about rotavirus infection

干预措施代码：

Intervention：

Publicly available information from the Centre for Health Protection (CHP) about rotavirus infection

Intervention code：

组别：

Intervention Group 1

样本量：

263

Group：

Intervention Group 1

Sample size：

干预措施：

1) Publicly available information from CHP about rotavirus infection; 2) Information about rotavirus infection and vaccination, and a hyperlink of a webpage showing private clinics that provide rotavirus vaccines; 3) Text message reminder for vaccination at children’s age of 6-8 weeks

干预措施代码：

Intervention：

1) Publicly available information from CHP about rotavirus infection; 2) Information about rotavirus infection and vaccination, and a hyperlink of a webpage showing private clinics that provide rotavirus vaccines; 3) Text message reminder for vaccination at children’s age of 6-8 weeks

Intervention code：

组别：

Intervention Group 2

样本量：

262

Group：

Intervention Group 2

Sample size：

干预措施：

1-3) Same intervention package as intervention group 1; 4) Contact details of a specific community health centre within the United Christian Nethersole Community Health Service (UCN) that provide free rotavirus vaccines; 5) A token that allow subjects to receive rotavirus vaccine for free at UCN

干预措施代码：

Intervention：

1-3) Same intervention package as intervention group 1; 4) Contact details of a specific community health centre within the United Christian Nethersole Community Health Service (UCN) that provide free rotavirus vaccines; 5) A token that allow subjects to receive rotavirus vaccine for free at UCN

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

 Shatin 

Country：

China 

Province：

Hong Kong SAR 

City：

Shatin 

单位(医院)：

威爾士親王醫院 

单位级别：

三级医院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary Hospital

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

 Kwun Tong 

Country：

China 

Province：

Hong Kong SAR 

City：

Kwun Tong 

单位(医院)：

United Christian Hospital 

单位级别：

三级医院 

Institution
hospital：

United Christian Hospital

Level of the institution：

Tertiary Hospital

测量指标：

Outcomes：

指标中文名：

Uptake rate of rotavirus vaccine

指标类型：

主要指标

Outcome：

Uptake rate of rotavirus vaccine

Type：

Primary indicator

测量时间点：

In children at 8 months

测量方法：

Survey

Measure time point of outcome：

In children at 8 months

Measure method：

Survey

指标中文名：

Knowledge, attitudes and practices of mothers in relation to rotavirus vaccine

指标类型：

次要指标

Outcome：

Knowledge, attitudes and practices of mothers in relation to rotavirus vaccine

Type：

Secondary indicator

测量时间点：

Before and after receiving control or intervention information

测量方法：

Survey

Measure time point of outcome：

Before and after receiving control or intervention information

Measure method：

Survey

指标中文名：

Uptake rate of rotavirus vaccine in children at 8 months by family socioeconomic status

指标类型：

次要指标

Outcome：

Uptake rate of rotavirus vaccine in children at 8 months by family socioeconomic status

Type：

Secondary indicator

测量时间点：

In children at 8 months

测量方法：

Survey

Measure time point of outcome：

In children at 8 months

Measure method：

Survey

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

A study Research Assistant (RA) not involved with other follow-ups will randomly allocate all participants to either control or two intervention groups using block randomization with 1:1:1 ratio. Each group will have 262-263 participants.

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

A study Research Assistant (RA) not involved with other follow-ups will randomly allocate all participants to either control or two intervention groups using block randomization with 1:1:1 ratio. Each group will have 262-263 participants.

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：

Once the intervention has been allocated, this RA will not be blinded to participants group assignment, but the other RA conducting telephone interviews, investigators and participants will be blinded to participants group allocation.

Blinding：

Once the intervention has been allocated, this RA will not be blinded to participants group assignment, but the other RA conducting telephone interviews, investigators and participants will be blinded to participants group allocation.

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）：

Study results will be submitted and published in a peer-reviewed journal, with contact details of study investigators for access of anonymous data and study protocol

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

Study results will be submitted and published in a peer-reviewed journal, with contact details of study investigators for access of anonymous data and study protocol

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：

This RCT aims to provide key information about rotavirus disease and its vaccine and will not provide drugs as intervention. There are no anticipated risks to the subjects by participating in this study. The study data will be collected at two time-points: (i) a face-to-face interview followed by a self-administered questionnaire at enrolment in postnatal wards; and (ii) an online self-administered questionnaire at children’s age of approximately 8 months. In the first questionnaire, we will collect information on the key demographic information and mother’s knowledge, attitudes and practices in relation to rotavirus vaccine. In the online questionnaire, we will collect the child’s rotavirus vaccination history at 8 months old and an electronic copy of the child’s vaccination record card. In addition all participants will be asked about the knowledge, attitudes and practices in relation to rotavirus vaccine. Participants will be followed-up by phone if the final questionnaire is not completed. Knowledge, attitudes and practices of mothers will be assessed by questionnaires based on Health Belief Model (HBM). The HBM is a simple, widely used framework to explain human health decision-making and behaviour. It was developed in the 1950s and improved in 1980s. It contains six concepts to predict how humans make decisions. These include perceived susceptibility and severity of illnesses, perceived benefits and barriers of interventions, cues to action and self-efficacy. The questionnaires are based on previous intervention study to increase influenza vaccine uptake. The modified questionnaire will be pilot-tested in approximately 30 mothers at the postnatal wards of the two study hospitals so as to ensure the internal consistency of questionnaire items within constructs is acceptable. Questionnaires will then be refined if necessary.

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

This RCT aims to provide key information about rotavirus disease and its vaccine and will not provide drugs as intervention. There are no anticipated risks to the subjects by participating in this study. The study data will be collected at two time-points: (i) a face-to-face interview followed by a self-administered questionnaire at enrolment in postnatal wards; and (ii) an online self-administered questionnaire at children’s age of approximately 8 months. In the first questionnaire, we will collect information on the key demographic information and mother’s knowledge, attitudes and practices in relation to rotavirus vaccine. In the online questionnaire, we will collect the child’s rotavirus vaccination history at 8 months old and an electronic copy of the child’s vaccination record card. In addition all participants will be asked about the knowledge, attitudes and practices in relation to rotavirus vaccine. Participants will be followed-up by phone if the final questionnaire is not completed. Knowledge, attitudes and practices of mothers will be assessed by questionnaires based on Health Belief Model (HBM). The HBM is a simple, widely used framework to explain human health decision-making and behaviour. It was developed in the 1950s and improved in 1980s. It contains six concepts to predict how humans make decisions. These include perceived susceptibility and severity of illnesses, perceived benefits and barriers of interventions, cues to action and self-efficacy. The questionnaires are based on previous intervention study to increase influenza vaccine uptake. The modified questionnaire will be pilot-tested in approximately 30 mothers at the postnatal wards of the two study hospitals so as to ensure the internal consistency of questionnaire items within constructs is acceptable. Questionnaires will then be refined if necessary.

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：

  2020-11-10 00:13:47