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临床试验/NCT07123064
NCT07123064招募中不适用

Alleviating Loneliness in Older Adults Living in Poverty: A Multi-level Intervention

Education University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,344 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,344
试验地点
1
主要终点
UCLA Loneliness Scale

研究概览

简要总结

The study aims to reduce loneliness among Hong Kong Chinese older adults living in poverty with a multi-level intervention involving components at the individual, interpersonal, and community levels.

详细描述

Loneliness is widespread, with negative impacts on both individuals and society and associated direct and indirect healthcare and long-term care costs. Thus, it is imperative to alleviate loneliness in old age by implementing effective, accessible, affordable, and scalable interventions. Loneliness is often erroneously considered an individual problem due to personal failure. Still, growing evidence indicates that loneliness is caused by factors at multiple levels, including the individual, interpersonal, and community levels. Hence, a multi-level approach is recommended to alleviate loneliness.

However, multi-level interventions for reducing loneliness are in their infancy, and there is yet to be evidence to suggest that they are more effective than single-level interventions. The investigators will conduct an innovative and impactful study to fill this important research gap. This study is a single-blinded cluster, four-arm randomized controlled trial (RCT) designed to test the effect and cost-effectiveness of a multi-level intervention to alleviate loneliness among Hong Kong Chinese older adults living in poverty. The investigators will also adopt the modified biopsychosocial (BPS) model, called the BPS-Pathways model, as the theoretical framework to guide our selection of interventions, mediators, secondary outcomes, long-term outcomes, and impact.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 65 years or older
  • living in poverty (defined: inability to afford at least 5 items on the material deprivation index)
  • proficiency in spoken Cantonese
  • experiencing loneliness (defined: score of ≥ 6 on the 3-item UCLA Loneliness Scale)

排除标准

  • cognitive impairments, psychiatric disorders, learning disabilities, or active suicidal ideation
  • actively participating in other psychotherapy or psychosocial interventions in the past 1 year
  • Exclusion Criteria:

研究组 & 干预措施

First Arm

Experimental

Individual-level

干预措施: Individual Level (Behavioral)

Second Arm

Experimental

Individual- and Interpersonal-level

干预措施: Individual Level (Behavioral)

Second Arm

Experimental

Individual- and Interpersonal-level

干预措施: Interpersonal Level (Behavioral)

Third Arm

Experimental

Individual-, Interpersonal-, and Community-level

干预措施: Individual Level (Behavioral)

Third Arm

Experimental

Individual-, Interpersonal-, and Community-level

干预措施: Interpersonal Level (Behavioral)

Third Arm

Experimental

Individual-, Interpersonal-, and Community-level

干预措施: Community Level (Behavioral)

Forth Arm

Active Comparator

Education Control Group

干预措施: Education Control (Other)

结局指标

主要结局

UCLA Loneliness Scale

时间窗: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

The 20-item UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate feelings of loneliness. Each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80.

UCLA Loneliness Scale

时间窗: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month

The 20-item UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate feelings of loneliness. Each item will be rated from 1=Never to 4=Always. Total scores range from 20 to 80.

次要结局

  • Pittsburgh Sleep Quality Index(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • Satisfaction with Life Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • De Jong Gierveld Loneliness Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • Lawton Instrumental Activities of Daily Living(Baseline, 12-month, 24-month)
  • Activities of Daily Living(Baseline, 12-month, 24-month)
  • Physical Symptoms Inventory(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • Charlson Comorbidity Index(Baseline, 12-month, 24-month)
  • Perceived Stress Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • 6-Minutes Walking Test(Baseline, 12-month, 24-month)
  • Hospital Anxiety and Depression Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • Montreal Cognitive Assessment - Hong Kong(Baseline, 12-month, 24-month)
  • Montreal Cognitive Assessment - Hong Kong(Baseline, 12-month, 24-month)
  • Pittsburgh Sleep Quality Index(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • Satisfaction with Life Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • De Jong Gierveld Loneliness Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • Lawton Instrumental Activities of Daily Living(Baseline, 12-month, 24-month)
  • Activities of Daily Living(Baseline, 12-month, 24-month)
  • Physical Symptoms Inventory(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • Charlson Comorbidity Index(Baseline, 12-month, 24-month)
  • Perceived Stress Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)
  • 6-Minutes Walking Test(Baseline, 12-month, 24-month)
  • Hospital Anxiety and Depression Scale(Baseline, 2-month, 4-month, 6-month, 12-month, 24-month)

研究者

发起方
Education University of Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chou Kee Lee

Chair Professor of Social Policy

Education University of Hong Kong

研究点 (1)

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