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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Individual Level
  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 ses
• Поведенческое Interpersonal 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.
• Поведенческое Community 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.
• Другое Education 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.

Первичные конечные точки

• UCLA Loneliness Scale [Срок оценки: Baseline, 2-month, 4-month, 6-month, 12-month, 24-month]

Вторичные конечные точки (11)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

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

Критерии исключения

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 1 центр

• The Education University of Hong Kong — Гонконг

Публикации

• Surkalim DL, Luo M, Eres R, Gebel K, van Buskirk J, Bauman A, Ding D. The prevalence of loneliness across 113 countries: systematic review and meta-analysis. BMJ. 2022 Feb 9;376:e067068. doi: 10.1136/bmj-2021-067068. PMID 35140066
• Seguin-Fowler RA, Graham ML, Demment M, Uribe ALM, Rethorst CD, Szeszulski J. Multilevel Interventions Targeting Obesity: State of the Science and Future Directions. Annu Rev Nutr. 2024 Aug;44(1):357-381. doi: 10.1146/annurev-nutr-122123-020340. Epub 2024 Aug 12. PMID 38885446
• Santini ZI, Koyanagi A, Tyrovolas S, Haro JM, Fiori KL, Uwakwa R, Thiyagarajan JA, Webber M, Prince M, Prina AM. Social network typologies and mortality risk among older people in China, India, and Latin America: A 10/66 Dementia Research Group population-based cohort study. Soc Sci Med. 2015 Dec;147:134-43. doi: 10.1016/j.socscimed.2015.10.061. Epub 2015 Nov 4. PMID 26575604
• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426
• Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17. PMID 20716644
• Lloyd-Evans B, Frerichs J, Stefanidou T, Bone J, Pinfold V, Lewis G, Billings J, Barber N, Chhapia A, Chipp B, Henderson R, Shah P, Shorten A, Giorgalli M, Terhune J, Jones R, Johnson S. The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression. PLoS One. 2020 May 29;15(5):e0233535. doi: 1 PMID 32469922
• Lengnick-Hall R, Williams NJ, Ehrhart MG, Willging CE, Bunger AC, Beidas RS, Aarons GA. Eight characteristics of rigorous multilevel implementation research: a step-by-step guide. Implement Sci. 2023 Oct 23;18(1):52. doi: 10.1186/s13012-023-01302-2. PMID 37872618
• Hunter RF, de la Haye K, Murray JM, Badham J, Valente TW, Clarke M, Kee F. Social network interventions for health behaviours and outcomes: A systematic review and meta-analysis. PLoS Med. 2019 Sep 3;16(9):e1002890. doi: 10.1371/journal.pmed.1002890. eCollection 2019 Sep. PMID 31479454

Идентификаторы

NCT: NCT07123064 · 2023-2024-0624 · R8002-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗