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Effects of a Multimedia Educational Programme for Children with Asthma or Recurrent Wheeze: A Randomized Controlled Trial
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注册号：

Registration number：

 ChiCTR1800019706 

最近更新日期：

Date of Last Refreshed on：

 2018-11-24 20:48:52 

注册时间：

Date of Registration：

 2018-11-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effects of a Multimedia Educational Programme for Children with Asthma or Recurrent Wheeze: A Randomized Controlled Trial

Public title：

Effects of a Multimedia Educational Programme for Children with Asthma or Recurrent Wheeze: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effects of a Multimedia Educational Programme for Children with Asthma or Recurrent Wheeze: A Randomized Controlled Trial

Scientific title：

Effects of a Multimedia Educational Programme for Children with Asthma or Recurrent Wheeze: A Randomized 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：

Ng Sze Ka 

研究负责人：

Ng Sze Ka 

Applicant：

Ng Sze Ka 

Study leader：

Ng Sze Ka 

申请注册联系人电话：

Applicant telephone：

 +852 96418150

研究负责人电话：

Study leader's
telephone：

+852 96418150

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：

 szekaka@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 szekaka@yahoo.com

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九龍觀塘協和街130號

研究负责人通讯地址：

中國香港特別行政區新界九龍觀塘協和街130號

Applicant address：

Ward 4D, block P, United Christian Hospital, Kowloon, Hong Kong SAR, China

Study leader's address：

Ward 4D, block P, United Christian Hospital, Kowloon, 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：

香港基督教聯合醫院

Applicant's institution：

United Christian Hospital, Hong Kong

研究负责人所在单位：

香港基督教聯合醫院

Affiliation of the Leader：

United Christian Hospital, 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：

 2018.324

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：

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

Name of the ethic committee：

Joint Chinese University 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：

 2018-10-24 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士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

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：

基督教聯合醫院

Primary sponsor：

United Christian Hospital

研究实施负责（组长）单位地址：

中國香港特別行政區新界九龍觀塘協和街130號

Primary sponsor's address：

Ward 4D, block P, United Christian Hospital, Kowloon, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

兒童哮喘  

Target disease：

Childhood Asthma

研究疾病代码：

ICD-10

Target disease code：

ICD-10

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：

1. To determine the effectiveness of the multimedia education programme on improving asthma childrens health outcomes; 2. To determine the effectiveness of the multimedia education programme on enhancing parents KAP on asthma.  

Objectives of Study：

1. To determine the effectiveness of the multimedia education programme on improving asthma childrens health outcomes; 2. To determine the effectiveness of the multimedia education programme on enhancing parents KAP on asthma.

药物成份或治疗方案详述：

45-minute multimedia asthma education programme (videos, computer games, discussion session) and take home asthma education kits (QR code access right of asthma information and computer game) on top of usual care  

Description for medicine or protocol of treatment in detail：

45-minute multimedia asthma education programme (videos, computer games, discussion session) and take home asthma education kits (QR code access right of asthma information and computer game) on top of usual care  

纳入标准：

Inclusion criteria

排除标准：

Children:
1. Chronic lung disease, such as bronchopulmonary dysplasia, which will confound the lung function assessment;
2. Developmental delay;
3. Cannot communicate in Cantonese and understand Chinese;
4. Participation in similar study;
This study will exclude children aged 0 to 3 years old because making a certain diagnosis of asthma is difficult for young children given that wheezing or cough symptoms are common even for those who do not have asthma (Pedersen et al., 2011). Furthermore, adolescents (aged 12 to 17 years old) pose significant differences in cognitive ability compared with young children. They will have different delivery approaches to health education. Thus, children aged 12 to 17 years old will also be excluded from this study to decrease the confounding variables including level of anxiety, asthma control or medication adherence.
Parent:
1. Cannot communicate in Cantonese and understand Chinese;
2. Has no smartphone;
3. Participation in similar study.

Exclusion criteria：

Children:
1. Chronic lung disease, such as bronchopulmonary dysplasia, which will confound the lung function assessment;
2. Developmental delay;
3. Cannot communicate in Cantonese and understand Chinese;
4. Participation in similar study;
This study will exclude children aged 0 to 3 years old because making a certain diagnosis of asthma is difficult for young children given that wheezing or cough symptoms are common even for those who do not have asthma (Pedersen et al., 2011). Furthermore, adolescents (aged 12 to 17 years old) pose significant differences in cognitive ability compared with young children. They will have different delivery approaches to health education. Thus, children aged 12 to 17 years old will also be excluded from this study to decrease the confounding variables including level of anxiety, asthma control or medication adherence.
Parent:
1. Cannot communicate in Cantonese and understand Chinese;
2. Has no smartphone;
3. Participation in similar study.

研究实施时间：

Study execute time：

从 From 2018-12-01 00:00:00至 To 2019-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-12-01 00:00:00 至 To 2019-06-30 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 56

Group：

Experimental group

Sample size：

干预措施：

45-minute multimedia asthma education programme (videos, computer games, discussion session) and take home asthma education kits (QR code access right of asthma information and computer game) on top of usual care

干预措施代码：

Intervention：

45-minute multimedia asthma education programme (videos, computer games, discussion session) and take home asthma education kits (QR code access right of asthma information and computer game) on top of usual care

Intervention code：

组别：

Control group

样本量：

 56

Group：

Control group

Sample size：

干预措施：

Maintain usual care (inhaler administration video, inhaler technique assessment) and a pamphlet of inhaler technique with QR code for inhaler administration

干预措施代码：

Intervention：

Maintain usual care (inhaler administration video, inhaler technique assessment) and a pamphlet of inhaler technique with QR code for inhaler administration

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)：

 九龍 

Country：

China

Province：

Hong Kong SAR

City：

Kowloon

单位(医院)：

 基督教聯合醫院 

单位级别：

 基督教聯合醫院 

Institution
hospital：

United Christian Hospital

Level of the institution：

United Christian Hospital

测量指标：

Outcomes：

指标中文名：

Knowledge, attitiude and practice of asthma

指标类型：

主要指标

Outcome：

Knowledge, attitiude and practice of asthma

Type：

Primary indicator

测量时间点：

pre and post intervention and follw-up

测量方法：

questionnaire

Measure time point of outcome：

pre and post intervention and follw-up

Measure method：

questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

NA

Tissue：

NA

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

NA

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 4 岁 years
最大 Max age 11 岁 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）：

The potential participants will be randomly allocated to either the intervention or control group in equal probability to reduce the bias on this new method of intervention. Group assignments will be placed in sealed, opaque and identical envelopes at a randomised order to maintain the allocation concealment.

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

The potential participants will be randomly allocated to either the intervention or control group in equal probability to reduce the bias on this new method of intervention. Group assignments will be placed in sealed, opaque and identical envelopes at a randomised order to maintain the allocation concealment.

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：

Single blind

Blinding：

Single blind

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）：

未说明

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

Not stated

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：

未说明

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-11-24 20:48:52
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