ChiCTR2300072033 版本V1.0 版本创建时间2023/06/01 08:46:02 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：

 ChiCTR2300072033 

最近更新日期：

Date of Last Refreshed on：

 2023-06-01 08:45:55 

注册时间：

Date of Registration：

 2023-06-01 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Please fill in the data management platform. Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults: a single-/within-group study design for volunteers

Public title：

Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults: a single-/within-group study design for volunteers

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults: a single-/within-group study design for volunteers

Scientific title：

Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults-a single-/within-group study design for volunteers

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：

HO Hok Man 

研究负责人：

HO Hok Man 

Applicant：

HO Hok Man 

Study leader：

HO Hok Man 

申请注册联系人电话：

Applicant telephone：

 +852 3943 9762

研究负责人电话：

Study leader's
telephone：

+852 3943 9762

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：

 kenho@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 kenho@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：

Room 731, 7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of Hong Kong

研究负责人通讯地址：

Room 731, 7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of Hong Kong

Applicant address：

Room 731, 7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of Hong Kong

Study leader's address：

Room 731, 7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of 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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The 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：

 2022.438-T

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：

 2022-09-13 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：

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

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of Hong Kong

Primary sponsor's address：

7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The Nethersole School of Nursing, The Chinese University of Hong Kong

具体地址：

7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of Hong Kong

Institution
hospital：

The Nethersole School of Nursing, The Chinese University of Hong Kong

Address：

7/F., Nethersole School of Nursing, Esther Lee Building, The Chinese University of Hong Kong

经费或物资来源：

Phase 2 of Mental Health Initiatives Funding Scheme；Advisory Committee on Mental Health, Health Bureau

Source(s) of funding：

Phase 2 of Mental Health Initiatives Funding Scheme；Advisory Committee on Mental Health, Health Bureau

研究疾病：

Mental health literacy, social support, quality of life  

Target disease：

Mental health literacy, social support, quality of life

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：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

1. To empower volunteers (aged 40 or above) with knowledge and skills in (i) supporting and counselling for mental and social health needs of the under-privileged older adults; (ii) facilitating teleconsultation by doctor and tele-dispensing by pharmacist, and (iii) assisting H2H medication delivery and management; 2. To provide empirical evidence through evaluating the implementation and effectiveness of the programme from the perspectives of the volunteers over a 3-months follow up to inform its future use in other hospital clusters or geographical regions in Hong Kong.  

Objectives of Study：

1. To empower volunteers (aged 40 or above) with knowledge and skills in (i) supporting and counselling for mental and social health needs of the under-privileged older adults; (ii) facilitating teleconsultation by doctor and tele-dispensing by pharmacist, and (iii) assisting H2H medication delivery and management; 2. To provide empirical evidence through evaluating the implementation and effectiveness of the programme from the perspectives of the volunteers over a 3-months follow up to inform its future use in other hospital clusters or geographical regions in Hong Kong.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Volunteers (aged 40 or above), independent living and satisfactory physical and mental health, not having any acute medical and mental disorders recently.

Inclusion criteria

Volunteers (aged 40 or above), independent living and satisfactory physical and mental health, not having any acute medical and mental disorders recently.

排除标准：

Volunteers will be excluded if they have received training on mental health first aid prior to this study.

Exclusion criteria：

Volunteers will be excluded if they have received training on mental health first aid prior to this study.

研究实施时间：

Study execute time：

从 From 2023-05-01 00:00:00至 To 2025-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-05-01 00:00:00 至 To 2025-02-01 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 50

Group：

Intervention group

Sample size：

干预措施：

Volunteer training programme

干预措施代码：

Intervention：

Volunteer training programme

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Salvation Army 

单位级别：

 District-based 

Institution
hospital：

Salvation Army

Level of the institution：

District-based

测量指标：

Outcomes：

指标中文名：

Mental health literacy (volunteers)

指标类型：

主要指标

Outcome：

Mental health literacy (volunteers)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Social support (volunteers)

指标类型：

主要指标

Outcome：

Social support (volunteers)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of life (volunteers)

指标类型：

主要指标

Outcome：

Quality of life (volunteers)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

NA

组织：

Sample Name：

NA

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 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 volunteer group adopted a single-/within-group study design, thereby randomization is not applicable in this study group

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

The volunteer group adopted a single-/within-group study design, thereby randomization is not applicable in this study 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：

None

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

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）：

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and DSA

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

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and SAP and DSA

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 the data collected will be encrypted with password. All forms of data will be destroyed 7 years after completion of the project.

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

All the data collected will be encrypted with password. All forms of data will be destroyed 7 years after completion of the project.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-06-01 08:45:55