ChiCTR2400082203 版本V1.0 版本创建时间2024/03/22 16:22:31 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：

ChiCTR2400082203 

最近更新日期：

Date of Last Refreshed on：

2024-03-22 16:22:26 

注册时间：

Date of Registration：

2024-03-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Public title：

Pilot Project to Mitigate Health Impact of Hot Weather – A Randomised Control Trial to assess effectiveness of a high-impact intervention programme on the health of older people

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Pilot Project to Mitigate Health Impact of Hot Weather – A Randomised Control Trial to assess effectiveness of a high-impact intervention programme on the health of older people

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：

 

研究负责人：

 

Applicant：

Eric Lai 

Study leader：

Eric Lai 

申请注册联系人电话：

Applicant telephone：

+852 3943 5478

研究负责人电话：

Study leader's telephone：

+852 3943 5478

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：

etclai@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

etclai@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：

研究负责人通讯地址：

Applicant address：

11/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

Study leader's address：

11/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, 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：

Applicant's institution：

CUHK Institute of Health Equity

研究负责人所在单位：

Affiliation of the Leader：

CUHK Institute of Health Equity

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：

SBRE-23-0582

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：

Name of the ethic committee：

CUHK Survey and Behavioural Research Ethics

伦理委员会批准日期：

Date of approved by ethic committee：

2024-03-20 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Survey and Behavioural Research Ethics Committee

伦理委员会联系地址：

Contact Address of the ethic committee：

Room 301, Pi Chiu Building, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3943 4209

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：

Primary sponsor：

CUHK Jockey Club Institute of Ageing

研究实施负责（组长）单位地址：

Primary sponsor's address：

Rm 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

具体地址：

Institution
hospital：

CUHK Jockey Club Institute of Ageing

Address：

Rm 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

经费或物资来源：

Source(s) of funding：

The Hong Kong Jockey Club Charities Trust

Target disease：

Heat-related Illnesses

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：

 

Objectives of Study：

The objective of the study is to assess the impact of a multi-component heat-health intervention on heat-related illnesses and unplanned medical consultations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Participants will be recruited from community settings in community elderly centers. They will first be screened with a screening questionnaire covering the following domains: frailty status, polypharmacy, housing type, living arrangement, functional independence, financial difficulties and advanced age. Participants will then be classified into three risk groups – high, medium and low, according to the scores they obtained from the screening questionnaire. Intervention for the high-risk group: Participants in the high-risk groups will be visited at their homes for three times, with three to four weeks spaced out between the visits. Each visit would consist a survey to assess participants’ health conditions and also on heat-related knowledge. Staff would also provide education to the participants about the strategies for adapting to hot weather where appropriate. An assessment of home environment would also be carried out during the first home visit. Minor home modification would be conducted during the second and third visit if possible areas of modification had been identified in the assessment. Medium-risk intervention: For medium-risk individuals, a less intensive intervention framework is developed in which participants will also be arranged with three encounters, but they are offered with at least one home visits depending on needs. The second encounter will entail health-related meaningful activities which also include educational components regarding heat-related knowledge. The third encounter would be a home visit which would have an assessment of home environment and possible minor home modification. The order of the three encounters could differ according to operational needs.  

纳入标准：

Inclusion criteria

Inclusion criteria for recruitment of participants are of the Hong Kong older population. 1. 60 – 100 years old; 2. Community- dwelling older adults 3. Identified as having medium or high risk through the screening survey

排除标准：

Exclusion criteria：

Exclusion criteria includes: 1. If individuals have significant and unstable medical and psychiatric conditions 2. Having cognitive impairment

研究实施时间：

Study execute time：

从 From 2024-05-01 00:00:00至 To 2026-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-05-01 00:00:00 至 To 2026-05-01 00:00:00  

干预措施：

Interventions：

组别：

样本量：

192

Group：

High-risk intervention group

Sample size：

干预措施：

干预措施代码：

Intervention：

High-impact intervention programme

Intervention code：

组别：

样本量：

192

Group：

High-risk control group

Sample size：

干预措施：

干预措施代码：

Intervention：

Delayed high-impact intervention programme

Intervention code：

组别：

样本量：

425

Group：

Medium-risk intervention group

Sample size：

干预措施：

干预措施代码：

Intervention：

Medium-risk intervention programme

Intervention code：

组别：

样本量：

425

Group：

Medium-risk control group

Sample size：

干预措施：

干预措施代码：

Intervention：

Delayed medium-impact intervention programme

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

China 

Province：

Hong Kong 

City：

 

单位(医院)：

 

单位级别：

 

Institution
hospital：

Community

Level of the institution：

Community

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

Number of unplanned medical consultations

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

1. Before intervention; 2. 3-4 weeks after intervention; 3. 6-8 weeks after intervention

Measure method：

Survey

指标中文名：

指标类型：

次要指标

Outcome：

Self-rated health

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

1. Before intervention; 2. 3-4 weeks after intervention; 3. 6-8 weeks after intervention

Measure method：

Survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

N/A

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 100 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）：

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

The completion of the screening survey would divide the participants into two groups: high-risk (Score 4-7) and medium-risk (1-3). Then participant would be randomized into two groups: intervention group and control group, using the Microsoft Office Excel software by the research assistant, to determine which participants would be allocated to the intervention or the control group.

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：

None

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

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)：

N/A

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

Data will be collected using Qualtrics and strictly confidential. All identifiable information would be replaced by a number during data analysis. The data will be stored securely in PI’s password-protected computer for 5 years.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-03-22 16:22:26