ChiCTR2300072034 版本V1.0 版本创建时间2023/06/01 09:01:16 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：

 ChiCTR2300072034 

最近更新日期：

Date of Last Refreshed on：

 2023-06-01 09:01:10 

注册时间：

Date of Registration：

 2023-06-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults: a two-arm, assessor blind randomized wait-list controlled trial for recipients

Public title：

Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults: a two-arm, assessor blind randomized wait-list controlled trial for recipients

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 two-arm, assessor blind randomized wait-list controlled trial for recipients

Scientific title：

Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults: a two-arm, assessor blind randomized wait-list controlled trial for recipients

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：

Hong Kong

单位(医院)：

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

具体地址：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, Hong Kong

Institution
hospital：

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

Address：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, NT, 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：

Loneliness, anxiety, depressive symptoms  

Target disease：

Loneliness, anxiety, depressive symptoms

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：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To develop a Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults (hereafter "Age with Good Mood") for under-privileged older adults (recipients) with chronic illness through tele-consultations and volunteer-assisted drug dispensing and management from hospital to home (H2H), and volunteer-run home visits and telephone calls for mental health and social support;  

Objectives of Study：

1. To develop a Age with good mood: a volunteer network based medical-social collaborative programme for supporting underprivileged older adults (hereafter "Age with Good Mood") for under-privileged older adults (recipients) with chronic illness through tele-consultations and volunteer-assisted drug dispensing and management from hospital to home (H2H), and volunteer-run home visits and telephone calls for mental health and social support; 2. To mitigate the loneliness, anxiety and depressive symptoms of recipients by trained volunteers, empowering them with better self-care capability through enhancing their mental health and social support by volunteer-run home visits and telephone calls, and improving their accessibility to medical and pharmacy service through teleconsultations and tele-dispensing, as well as mental health literacy; and 3. To provide empirical evidence through evaluating the implementation and effectiveness of the programme from the perspectives of the underprivileged older adults 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：

Older adults (aged 60 or above) with chronic illness, living alone or with spouse only, and receiving CSSA / OALA/ waivers of HA.

Inclusion criteria

Older adults (aged 60 or above) with chronic illness, living alone or with spouse only, and receiving CSSA / OALA/ waivers of HA.

排除标准：

Older adults will be excluded if they are: (i) living with children or younger siblings; or (ii) living in residential care homes; or (iii) living with other support workers (e.g., migrant domestic workers).

Exclusion criteria：

Older adults will be excluded if they are: (i) living with children or younger siblings; or (ii) living in residential care homes; or (iii) living with other support workers (e.g., migrant domestic workers).

研究实施时间：

Study execute time：

从 From 2023-07-01 00:00:00至 To 2025-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-07-01 00:00:00 至 To 2025-02-01 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 75

Group：

Intervention group

Sample size：

干预措施：

Volunteer-assisted programme with combination of teleconsultation, drug dispensing and management, and mental health and social support

干预措施代码：

Intervention：

Volunteer-assisted programme with combination of teleconsultation, drug dispensing and management, and mental health and social support

Intervention code：

组别：

Control group

样本量：

 75

Group：

Control group

Sample size：

干预措施：

We will employ wait-list control on recipients. Recipients who are randomly assigned to the control group will receive the same teleconsultation services, drug delivery and volunteer service.

干预措施代码：

Intervention：

We will employ wait-list control on recipients. Recipients who are randomly assigned to the control group will receive the same teleconsultation services, drug delivery and volunteer service.

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)：

 Alice Ho Miu Ling Nethersole Hospital 

单位级别：

 District-based 

Institution
hospital：

Alice Ho Miu Ling Nethersole Hospital

Level of the institution：

District-based

测量指标：

Outcomes：

指标中文名：

Loneliness

指标类型：

主要指标

Outcome：

Loneliness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Depressive symptoms

指标类型：

主要指标

Outcome：

Depressive symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Mental health literacy

指标类型：

主要指标

Outcome：

Mental health literacy

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

指标类型：

主要指标

Outcome：

Social support

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Anxiety

指标类型：

主要指标

Outcome：

Anxiety

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 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 randomization scheme will be generated through the website Randomization.com by a statistician of the research team who does not involve participant recruitment, intervention delivery, or data collection.

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

The randomization scheme will be generated through the website Randomization.com by a statistician of the research team who does not involve participant recruitment, intervention delivery, or data collection.

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：

Research assistant collecting data on outcome measures will be blinded to the group allocation of recipients.

Blinding：

Research assistant collecting data on outcome measures will be blinded to the group allocation of recipients.

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 09:01:10