【ChiCTR2300072909】Protecting older people from loneliness during the coronavirus (Covid-19) and other novel infectious disease pandemic

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基本信息

登记号

ChiCTR2300072909

试验状态

结束

药物名称

药物类型

规范名称

首次公示信息日的期

2023-06-28

临床申请受理号

靶点

适应症

Loneliness

试验通俗题目

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

试验专业题目

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

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

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.

盲法

试验项目经费来源

Collaborative Research Fund

试验范围

目标入组人数

322;151

实际入组人数

第一例入组时间

2021-01-02

试验终止时间

2023-06-30

是否属于一致性

入选标准

The inclusion criteria for participants in the RCT on loneliness will be: 1. Aged 65 years 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); 9. Feeling lonely (cut-off >= 6 of 3-item UCLA Loneliness Scale). The inclusion criteria for the RCT on volunteering are: 1. Aged 50 -70 years; 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; 7. Feeling lonely (cut-off >= 6 of 3-item UCLA Loneliness Scale).；

排除标准

None；

研究者信息

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试验机构

The Education University of Hong Kong

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