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

Not Applicable

Not yet recruiting

• Conditions: Loneliness; Poverty

• Registration Number: NCT07123064
• Lead Sponsor: Education University of Hong Kong

Brief Summary

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.

Detailed Description

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. Consequently, 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. We 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. We 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-01
• Primary Completion: 2029-05-31
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1344

Inclusion Criteria

• 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)

Exclusion Criteria

• 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:

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
UCLA Loneliness Scale	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.
De Jong Gierveld Loneliness Scale	Baseline, 2-month, 4-month, 6-month, 12-month, 24-month	The De Jong Gierveld Loneliness Scale is known for assessing loneliness with social and emotional loneliness subscale. Each item will be rated from 1=Yes to 3=No. Total scores range from 0 to 6, with subscale score ranging from 0 to 3.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with Life Scale	Baseline, 2-month, 4-month, 6-month, 12-month, 24-month	SWLS measures the subjective well-being and life satisfaction. Each item will be rated from 1=Strongly disagree to 7=Strongly agree. Total scores range from 5 to 35.
Lawton Instrumental Activities of Daily Living	Baseline, 24-month	IADL is used to measure participant's ability in performing instrumental activities. Each item will be rated 0=dependent to 1=independent. Total scores range from 0 to 8.
Activities of Daily Living	Baseline, 24-month	ADL is used to measure participant's independence in completing activities of daily living. Each item will be rate from 0=dependent to 5/10=independent. Total scores range from 0 to 100.
Physical Symptoms Inventory	Baseline, 2-month, 4-month, 6-month, 12-month, 24-month	Participants will rate the presence of each physical symptom in the past 30 days from 0=Never to 4=Often. Total scores range from 0 to 72.
Pittsburgh Sleep Quality Index	Baseline, 2-month, 4-month, 6-month, 12-month, 24-month	PSQI evaluates seven components of sleep: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Each item will be rated from 0=No difficulty to 3=Severe difficulty. Total scores range from 0 to 21,
Perceived Stress Scale	Baseline, 2-month, 4-month, 6-month, 12-month, 24-month	PSS is use to measure perceived stress levels. Each item will be rated from 0=Never to 4=Very often. Total scores range from 0 to 56.
Hospital Anxiety and Depression Scale	Baseline, 2-month, 4-month, 6-month, 12-month, 24-month	HADS measure the severity of anxiety and depression. Each item will be rated from 0=Not at all to 3=Most of the time. Total score range from 0 to 42.
Charlson Comorbidity Index	Baseline, 12-month, 24-month	Participants will rate the presence a list of 16 comorbid condition. Total scores range from 0 to 37.
6-Minutes Walking Test	Baseline, 12-month, 24-month	Participants will be asked to walk the furthest distance possible in 6 minutes, rate their level of breathlessness using the Borg scale from 0=No breathlessness to 10=Maximal breathlessness.
Montreal Cognitive Assessment - Hong Kong	Baseline, 2-month, 4-month, 6-month, 12-month, 24-month	MoCA-HK is a tool to evaluate cognitive functioning in older adults, which compromises of seven cognitive domains. Total score range from 0 to 30.

Trial Locations

Locations (1)

The Education University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong