ChiCTR2300072909 版本V1.1 版本创建时间2023/08/23 10:28:46 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：

 ChiCTR2300072909 

最近更新日期：

Date of Last Refreshed on：

 2023-06-28 09:01:38 

注册时间：

Date of Registration：

 2023-06-28 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Protecting older people from loneliness during the coronavirus (Covid-19) and other novel infectious disease pandemic

Public title：

Protecting older people from loneliness during the coronavirus (Covid-19) and other novel infectious disease pandemic

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Protecting older people from loneliness during the coronavirus (Covid-19) and other novel infectious disease pandemic

Scientific title：

Protecting older people from loneliness during the coronavirus (Covid-19) and other novel infectious disease pandemic

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：

CHOU Kee Lee 

研究负责人：

CHOU Kee Lee 

Applicant：

CHOU Kee Lee 

Study leader：

CHOU Kee Lee 

申请注册联系人电话：

Applicant telephone：

 +852 2948 7473

研究负责人电话：

Study leader's
telephone：

+852 2948 7473

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：

 klchou@eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

 klchou@eduhk.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：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

研究负责人通讯地址：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

Applicant address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

Study leader's address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, 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 Education University of Hong Kong

Applicant's institution：

The Education University of Hong Kong

研究负责人所在单位：

The Education University of Hong Kong

Affiliation of the Leader：

The Education 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：

 A2019-2020-0442

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：

The Education University of Hong Kong, Human Research Ethics Committee

Name of the ethic committee：

The Education University of Hong Kong, Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-02-19 00:00:00

伦理委员会联系人：

Patsy Chung

Contact Name of the ethic committee：

Patsy Chung

伦理委员会联系地址：

The Education University of Hong Kong c/o Research and Development Office 10 Lo Ping Road, Tai Po, Hong Kong

Contact Address of the ethic committee：

The Education University of Hong Kong c/o Research and Development Office 10 Lo Ping Road, Tai Po, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2948 8888

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hrec@eduhk.hk

研究实施负责（组长）单位：

The Education University of Hong Kong

Primary sponsor：

The Education University of Hong Kong

研究实施负责（组长）单位地址：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kong

Primary sponsor's address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, 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)：

University Grants Committee

具体地址：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR, China

Institution
hospital：

University Grants Committee

Address：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR, China

经费或物资来源：

Collaborative Research Fund

Source(s) of funding：

Collaborative Research Fund

研究疾病：

Loneliness  

Target disease：

Loneliness

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To protect community-dwelling older adults from loneliness, we will develop and evaluate two psycho-social interventions for use during times such as the COVID-19 pandemic and other future novel infectious disease pandemics. To meet the huge demand for such interventions during future pandemics, we plan to recruit and train retirees to implement a couple of promising interventions. To establish such a pool of human capital for future crises more easily, we argue that it is crucial to provide scientific evidence of the benefits of volunteerism for retirees. Consequently, the overall objective of this proposed study is to develop and evaluate two psycho-social interventions that are likely to prove mutual benefits to volunteers who will implement the interventions and those who will receive them in a dual randomized controlled trials (RCTs). The specific objectives are as follows: 1. To evaluate the effects of four-week telephone-delivered behavioral activation and telephone-delivered mindfulness interventions on primary (loneliness, social network size, social support) and secondary outcomes (perceived stress, sleep quality, post-traumatic stress disorder, anxiety, and depressive symptoms), relative to a four-week telephone-delivered befriending group using a three-arm RCT with a large representative sample of community-dwelling older adults who are living alone, have household income below the official poverty line, and who are digitally excluded. Data will be collected at baseline and four-week, three-month, and six- month follow-up assessments. 2. To examine the effects of volunteering on the primary and secondary outcomes, as well as cognitive functioning among retirees aged between 50 and 70 years who will be recruited and trained to deliver telephone-delivered behavioral activation, telephone-delivered mindfulness, and telephone-delivered befriending interventions, using a two-arm RCT. Data will be collected at baseline and 6-month and 12-month follow-up assessments. 3. To examine the moderating role of volunteering in the link between social network or social support and loneliness, as well as the association of perceived stress with other secondary outcomes (e.g. depressive and anxiety symptoms) among retirees aged between 50 and 70 years, who will be recruited and trained to deliver the telephone-delivered behavioral activation, telephone-delivered mindfulness, and telephone-delivered befriending interventions, using a two-arm RCT. 4. To examine whether or not the effects of the loneliness interventions (i.e., telephone- delivered behavioral activation, telephone-delivered mindfulness, and the telephone-delivered befriending interventions) and the impacts of volunteering on the primary and secondary outcomes is mediated by changing diurnal salivary cortisol patterns and levels of the salivary C Reactive Protein, using a three-arm and two-arm RCT, respectively. 5. To examine how responses to the different loneliness interventions (i.e. telephone-delivered behavioral activation, telephone-delivered mindfulness and telephone-delivered befriending interventions) depend on genetic markers using four approaches (candidate gene, genome- wide association study (GWAS), biological pathway related single nucleotide polymorphisms (SNPs), and polygenic risk scores) using a three-arm RCTs.pathway related single nucleotide polymorphisms (SNPs), and polygenic risk scores) using a three-arm RCTs.  

Objectives of Study：

To protect community-dwelling older adults from loneliness, we developed and are evaluating two psycho-social interventions for use during times such as the COVID-19 pandemic and other future novel infectious disease pandemics. The specific objectives are as follows: 1. To protect community-dwelling older adults from loneliness, we will develop and evaluate two psycho-social interventions for use during times such as the COVID-19 pandemic and other future novel infectious disease pandemics. To meet the huge demand for such interventions during future pandemics, we plan to recruit and train retirees to implement a couple of promising interventions. To establish such a pool of human capital for future crises more easily, we argue that it is crucial to provide scientific evidence of the benefits of volunteerism for retirees. Consequently, the overall objective of this proposed study is to develop and evaluate two psycho-social interventions that are likely to prove mutual benefits to volunteers who will implement the interventions and those who will receive them in a dual randomized controlled trials (RCTs). The specific objectives are as follows: 1. To evaluate the effects of four-week telephone-delivered behavioral activation and telephone-delivered mindfulness interventions on primary (loneliness, social network size, social support) and secondary outcomes (perceived stress, sleep quality, post-traumatic stress disorder, anxiety, and depressive symptoms), relative to a four-week telephone-delivered befriending group using a three-arm RCT with a large representative sample of community-dwelling older adults who are living alone, have household income below the official poverty line, and who are digitally excluded. Data will be collected at baseline and four-week, three-month, and six- month follow-up assessments. 2. To examine the effects of volunteering on the primary and secondary outcomes, as well as cognitive functioning among retirees aged between 50 and 70 years who will be recruited and trained to deliver telephone-delivered behavioral activation, telephone-delivered mindfulness, and telephone-delivered befriending interventions, using a two-arm RCT. Data will be collected at baseline and 6-month and 12-month follow-up assessments. 3. To examine the moderating role of volunteering in the link between social network or social support and loneliness, as well as the association of perceived stress with other secondary outcomes (e.g. depressive and anxiety symptoms) among retirees aged between 50 and 70 years, who will be recruited and trained to deliver the telephone-delivered behavioral activation, telephone-delivered mindfulness, and telephone-delivered befriending interventions, using a two-arm RCT. 4. To examine whether or not the effects of the loneliness interventions (i.e., telephone- delivered behavioral activation, telephone-delivered mindfulness, and the telephone-delivered befriending interventions) and the impacts of volunteering on the primary and secondary outcomes is mediated by changing diurnal salivary cortisol patterns and levels of the salivary C Reactive Protein, using a three-arm and two-arm RCT, respectively. 5. To examine how responses to the different loneliness interventions (i.e. telephone-delivered behavioral activation, telephone-delivered mindfulness and telephone-delivered befriending interventions) depend on genetic markers using four approaches (candidate gene, genome- wide association study (GWAS), biological pathway related single nucleotide polymorphisms (SNPs), and polygenic risk scores) using a three-arm RCTs.pathway related single nucleotide polymorphisms (SNPs), and polygenic risk scores) using a three-arm RCTs.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

The inclusion criteria for participants in the RCT on loneliness will be: 1) aged 65 and older; 2) able to communicate through Cantonese over the phone; 3) they have mild or no cognitive impairment; 4) no psychiatric disorder, learning disability, or active suicidal ideation; 5) living in poverty defined by the official Hong Kong poverty line, i.e. half of median household income adjusted by household size; 6) living alone; 7) no access to internet; 8) not engage in regular systematic mindfulness mediation or related mind-body practice (>2 times per week); and 9) feeling lonely (cut-off >=6 of 3-item UCLA Loneliness Scale). The inclusion criteria for the RCT on volunteering are: 1) aged between 50 and 70; 2) willing to be trained and serve at least two hours per week for six months; 3) at least three years education in secondary school; 4) no major physical and mental health problems, or cognitive impairment; 5) not working full- or part-time; 6) people who have not engaged in formal voluntary work more than 4 times within the last year; and 7) feeling lonely (cut-off >=6 of 3-item UCLA Loneliness Scale).

Inclusion criteria

The inclusion criteria for participants in the RCT on loneliness will be: 1) aged 65 and older; 2) able to communicate through Cantonese over the phone; 3) they have mild or no cognitive impairment; 4) no psychiatric disorder, learning disability, or active suicidal ideation; 5) living in poverty defined by the official Hong Kong poverty line, i.e. half of median household income adjusted by household size; 6) living alone; 7) no access to internet; 8) not engage in regular systematic mindfulness mediation or related mind-body practice (>2 times per week); and 9) feeling lonely (cut-off >=6 of 3-item UCLA Loneliness Scale). The inclusion criteria for the RCT on volunteering are: 1) aged between 50 and 70; 2) willing to be trained and serve at least two hours per week for six months; 3) at least three years education in secondary school; 4) no major physical and mental health problems, or cognitive impairment; 5) not working full- or part-time; 6) people who have not engaged in formal voluntary work more than 4 times within the last year; and 7) feeling lonely (cut-off >=6 of 3-item UCLA Loneliness Scale).

排除标准：

None

Exclusion criteria：

None

研究实施时间：

Study execute time：

从 From 2021-01-02 00:00:00至 To 2023-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-04-01 00:00:00 至 To 2021-12-31 00:00:00

干预措施：

Interventions：

组别：

Tele-BA (RCT on Loneliness)

样本量：

 322

Group：

Tele-BA (RCT on Loneliness)

Sample size：

干预措施：

Tele-BA is an 8 bi-weekly 30-minute sessions over a period of four weeks to be more practical for telephone sessions intervention. Participants will be asked to review their daily activity patterns, and then chose activity goals and review their successes and areas of improvement.

干预措施代码：

 BA

Intervention：

Tele-BA is an 8 bi-weekly 30-minute sessions over a period of four weeks to be more practical for telephone sessions intervention. Participants will be asked to review their daily activity patterns, and then chose activity goals and review their successes and areas of improvement.

Intervention code：

组别：

Tele-M (RCT on Loneliness)

样本量：

 322

Group：

Tele-M (RCT on Loneliness)

Sample size：

干预措施：

Tele-M is an eight 30-minute sessions over a period of 4 weeks and from a smartphone app to a telephone-based intervention. Before the intervention, participants will view a 5-minute introductory video explaining how to prepare for and what to expect from the intervention. Each session trains specific techniques via didactic explanation and formal guided practice with 3 to 10-minute homework practice each day.

干预措施代码：

 M

Intervention：

Tele-M is an eight 30-minute sessions over a period of 4 weeks and from a smartphone app to a telephone-based intervention. Before the intervention, participants will view a 5-minute introductory video explaining how to prepare for and what to expect from the intervention. Each session trains specific techniques via didactic explanation and formal guided practice with 3 to 10-minute homework practice each day.

Intervention code：

组别：

Tele-BF (RCT on Loneliness)

样本量：

 322

Group：

Tele-BF (RCT on Loneliness)

Sample size：

干预措施：

Tele-BF refers to regular contact between a volunteer who acts as or becomes friends with older adults. A total of eight Tele-BF sessions for four weeks, each session lasting approximately 30 minutes. Tele-BF consists of a series of conversations between the participant and the volunteer, which are often related to everyday topics.

干预措施代码：

 BF

Intervention：

Tele-BF refers to regular contact between a volunteer who acts as or becomes friends with older adults. A total of eight Tele-BF sessions for four weeks, each session lasting approximately 30 minutes. Tele-BF consists of a series of conversations between the participant and the volunteer, which are often related to everyday topics.

Intervention code：

组别：

Volunteering Group (RCT on Volunteering)

样本量：

 151

Group：

Volunteering Group (RCT on Volunteering)

Sample size：

干预措施：

Participants in the intervention group will receive our 4- week tested motivation program and the training for each intervention they will be assigned to implement. The period of time for their volunteering work is six months, with a minimum volunteering time of 2 hours per week

干预措施代码：

 VG

Intervention：

Participants in the intervention group will receive our 4- week tested motivation program and the training for each intervention they will be assigned to implement. The period of time for their volunteering work is six months, with a minimum volunteering time of 2 hours per week

Intervention code：

组别：

Active Control Group (RCT on Volunteering)

样本量：

 151

Group：

Active Control Group (RCT on Volunteering)

Sample size：

干预措施：

Participants in the active control condition will receive four one-hour telephone sessions of a psycho-education program for their retirement and healthy behaviors. The program aims to help participants manage life after retirement and teaches them how to increase engagement in healthy behaviors.

干预措施代码：

 ACG

Intervention：

Participants in the active control condition will receive four one-hour telephone sessions of a psycho-education program for their retirement and healthy behaviors. The program aims to help participants manage life after retirement and teaches them how to increase engagement in healthy behaviors.

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)：

 Community 

单位级别：

 Community 

Institution
hospital：

Community

Level of the institution：

Community

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：

De Jong Gierveld Loneliness Scale & Revised UCLA Loneliness Scale

Measure time point of outcome：

Measure method：

De Jong Gierveld Loneliness Scale & Revised UCLA Loneliness Scale

指标中文名：

Social Network

指标类型：

主要指标

Outcome：

Social Network

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Medical Outcomes - Social Support

指标类型：

主要指标

Outcome：

Medical Outcomes - 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：

Perceived Stress Scale

指标类型：

次要指标

Outcome：

Perceived Stress Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Sleep Quality

指标类型：

次要指标

Outcome：

Sleep Quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Impact of Event

指标类型：

次要指标

Outcome：

Impact of Event

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Patient Health

指标类型：

次要指标

Outcome：

Patient Health

Type：

Secondary 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：

Saliva

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 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）：

RCT on Loneliness: Upon completion of baseline assessment, participants are randomly assigned to either Tele-BA, Tele-MF, or Tele-BF using an online random number generated by a research assistant. RCT on Volunteering: Stratified randomization will be conducted based on gender and age using an online random number generated by a research assistant.

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

RCT on Loneliness: Upon completion of baseline assessment, participants are randomly assigned to either Tele-BA, Tele-MF, or Tele-BF using an online random number generated by a research assistant. RCT on Volunteering: Stratified randomization will be conducted based on gender and age using an online random number generated by a research assistant.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

NA

Blinding：

NA

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）：

NA

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

NA

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：

NA

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

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-06-28 09:01:33