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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07123064
Enrollment
1344
Registered
2025-08-14
Start date
2026-04-01
Completion date
2029-05-31
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness, Poverty

Keywords

Loneliness, Poverty, Cluster Randomized Controlled Trials, Older Adults, Mindfulness, SOLUS-D Programme, Group 4 Health, Neighbour Every Day, 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. 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.

Interventions

A 8-weekly, 1hour telephone-delivered sessions using mindfulness and SOLUS-D program. Key contents include: introduction to mindfulness - Body awareness and present moment experiences, emotional awareness and mind-body labeling, relaxation techniques and sensory discrimination, deepening awareness and accepting feelings, personal values, interconnection between thought patterns and emotions, identifying and analyzing of thought traps, and challenging thoughts and future planning. Maintenance sessions which focus on embedding mindfulness practices and SOLUS-D program among older adults as a persistent habit will be conducted.

BEHAVIORALInterpersonal Level

A 8 weekly, 1hr sessions through telephone or Zoom using the Group 4 Health. Key contents include: understanding the benefits of social connections, exploring self and community, community and action, support and breakthrough, summary and moving forward. Maintenance sessions which focus on continuous practice of support and community will be conducted.

BEHAVIORALCommunity Level

A 4 weekly, 2hour in-person sessions through (1) strengthening collective efficacy via neighbor identification with the community. Key contents include: building neighbourhood connections, getting to know each other, health aging, neighbourhood care, vibrant exploration, thriving community, connecting the dots.

OTHEREducation Control

Monthly monthly messages via text, graphics or voice recordings will be sent over a period of 6 months. Key content includes: healthy diet tips, recognizing warning signs of health, understanding dementia, fall prevention tips, health message, and anti-fraud tips.

Sponsors

Education University of Hong Kong
Lead SponsorOTHER
University College, London
CollaboratorOTHER
The Hong Kong Polytechnic University
CollaboratorOTHER
University of Texas at Austin
CollaboratorOTHER
Australian National University
CollaboratorOTHER
The University of Hong Kong
CollaboratorOTHER
Medical School Berlin
CollaboratorOTHER
Chinese University of Hong Kong
CollaboratorOTHER
University of Bern
CollaboratorOTHER
Linkoeping University
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Single Blinded, 4-arm cluster randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
UCLA Loneliness ScaleBaseline, 2-month, 4-month, 6-month, 12-month, 24-monthThe 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.

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality IndexBaseline, 2-month, 4-month, 6-month, 12-month, 24-monthPSQI 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,
Satisfaction with Life ScaleBaseline, 2-month, 4-month, 6-month, 12-month, 24-monthSWLS 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.
De Jong Gierveld Loneliness ScaleBaseline, 2-month, 4-month, 6-month, 12-month, 24-monthThe 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.
Lawton Instrumental Activities of Daily LivingBaseline, 12-month, 24-monthIADL 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 LivingBaseline, 12-month, 24-monthADL 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 InventoryBaseline, 2-month, 4-month, 6-month, 12-month, 24-monthParticipants 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.
Charlson Comorbidity IndexBaseline, 12-month, 24-monthParticipants will rate the presence a list of 16 comorbid condition. Total scores range from 0 to 37.
Perceived Stress ScaleBaseline, 2-month, 4-month, 6-month, 12-month, 24-monthPSS 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.
6-Minutes Walking TestBaseline, 12-month, 24-monthParticipants 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.
Hospital Anxiety and Depression ScaleBaseline, 2-month, 4-month, 6-month, 12-month, 24-monthHADS 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.
Montreal Cognitive Assessment - Hong KongBaseline, 12-month, 24-monthMoCA-HK is a tool to evaluate cognitive functioning in older adults, which compromises of seven cognitive domains. Total score range from 0 to 30.

Countries

Hong Kong

Contacts

PRINCIPAL_INVESTIGATORKee Lee Chou, PhD

The Education University of Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026