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Набор скоро начнётся NCT06882434

Holistic Integration for Healthy Longevity and Aging in Place

Без фазы С лечением Cognitive Decline Sarcopenia Depression Disorders Nutrition Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Local intervention program, Referral Process, Telehealth Education & Digital Integration.
Кому может быть актуально
Состояния в реестре: Cognitive Decline, Sarcopenia, Depression Disorders, Nutrition Disorder. Базовые параметры: от 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Holistic Integration for Healthy Longevity and Aging in Place - Establishing Full-spectrum Community-based Care System for Older People to Maintain Wellbeing Pursuing Abilities

Обзор

Background: Taiwan is experiencing rapid population aging, with a growing prevalence of chronic diseases and functional impairments among older adults. Existing Integrated Care for Older People (ICOPE) programs focus primarily on screening but lack sufficient follow-up and intervention. In response, the HI-HOPE Project was developed to establish a community-based, multidisciplinary intervention model to enhance intrinsic capacity and promote healthy aging in rural elderly populations. Survey and Screening: The study will be conducted in 30 community centers across Yunlin County, targeting older adults aged ≥55 years. Participants will undergo biannual screenings over two years, assessing cognitive function, depression, mobility, vitality (nutrition), hearing, vision, osteoporosis, polypharmacy, urological health, and social participation \& welfare. Intervention: Participants will be randomly assigned to either: HI-HOPE Integrated Care Group: On-Site Community Interventions: Exercise training, mindfulness, social activities, oral and swallowing rehabilitation, hearing and vision training. Telehealth \& Remote Education: Digital health monitoring, remote consultations, and health education. Referral Services: Access to specialized medical care, transportation assistance, and follow-up support. Control Group: Standard community care services without additional structured interventions. Outcome Measures: Primary outcomes include changes in intrinsic capacity of functional health metrics, including abnormalities of I-COPE components (mobility, cognitive status, depression, hearing, vision, vitality) . Secondary outcomes assess quality of life, activities of daily living, hospitalization, emergency visits, falls, and mortality rates over two years. Significance: This project integrates digital health technologies, interdisciplinary care, and community-based interventions to improve elderly health outcomes. The findings will guide the future scalability of integrated aging care models in Taiwan and beyond.

Подробное описание

General Introduction As the population ages, the prevalence of chronic diseases and functional impairments is increasing. Since 1980, the proportion of people aged 65 and older in Taiwan has been steadily rising, and in 2018, Taiwan officially became an aged society. It is projected to reach the status of a super-aged society by 2025. Achieving healthy longevity is a shared goal in an aging society. According to the World Health Organization (WHO), the purpose of promoting healthy aging is to help older adults maintain their physical functions, allowing them to engage in activities that bring them happiness. Maintaining intrinsic capacity is a key aspect of this goal. However, many elderly individuals experience multiple chronic diseases and polypharmacy, physical decline, reduced cognitive and learning abilities, and socio-economic disadvantages. These factors contribute to the progressive deterioration of their intrinsic capacity, posing significant challenges to achieving healthy aging.

Since 2018, National Taiwan University Hospital Yunlin Branch has actively reached out to remote rural communities, providing high-quality and convenient medical and health services to the elderly in Yunlin County. Observations over the years have shown that the prevalence of metabolic syndrome among the elderly in rural Yunlin is significantly high. Nutritional imbalances have led to 35.35% of elderly individuals having a BMI above the normal range, while 48.4% have stage II hypertension. Sarcopenia is also a concerning issue: 50.36% of seniors exhibit low grip strength, 16.82% require more than 16 seconds to complete five sit-to-stand movements, and 77.92% show signs of lower limb weakness in a 3-meter walk test. Compared to other regions in Taiwan and internationally, the elderly in Yunlin demonstrate lower physical fitness levels, highlighting the need for greater attention and assistance in ensuring their health and well-being.

Currently, a person-centered, community-based, integrated multidisciplinary assessment and intervention approach is the mainstream method for promoting health among older adults, supported by international evidence. The Integrated Care for Older People (ICOPE) model, proposed by the World Health Organization (WHO), identifies six key intrinsic capacities that need to be maintained for healthy aging: cognition, mobility, nutrition, depression, hearing, and vision. In 2017, WHO published community-level intervention guidelines that provided detailed assessments and recommendations for integrated community-based care. The guidelines emphasize resource integration, follow-up interventions, and a well-structured healthcare support system to enhance community-wide care.

The Health Promotion Administration (HPA) of Taiwan's Ministry of Health and Welfare has actively promoted the ICOPE framework. In 2021, it launched a pilot program for assessing and preventing functional decline in older adults, led by local health departments. By 2023, this initiative had expanded to all 22 counties and cities across Taiwan, with hospitals and medical institutions collaborating to conduct screenings. However, the current ICOPE implementation model is still primarily hospital-centered, making it less accessible to older adults in remote or mobility-limited communities.

A literature review and expert discussions indicate that Taiwan's ICOPE model focuses mainly on screening, with insufficient follow-up and referral systems. Due to the diverse and complex health issues faced by older adults, implementing follow-up care remains a major challenge. For example, in Yunlin County, nearly 8,000 screening surveys were completed in 2022, yet half of those who needed follow-up assessments did not receive referrals, and 95% of cases lacked follow-up within six months. Despite significant efforts by Yunlin's health authorities to implement ICOPE, the lack of case management personnel and a comprehensive medical support system has made intervention and follow-up care difficult. Thus, establishing a structured intervention model and improving implementation strategies is crucial for the future development of ICOPE in Taiwan.

Currently, various health promotion programs operate independently, often lacking sufficient cross-sector communication. This results in low service utilization rates due to unclear resource availability for elderly individuals and caregivers. Different approaches to community-based elderly care-such as hospital referrals, on-site community interventions, and telehealth monitoring-should be integrated to provide the most appropriate care and support.

To address these challenges, National Taiwan University Hospital Yunlin Branch is leveraging its experience in the Apollo Community Care Model, in collaboration with The National Health Research Institutes Aging and Health Welfare Research Center, The Yunlin County Government, and Yunlin University of Science and Technology. This initiative introduces the HI-HOPE Project, which focuses on

A senior-centered, community-based model A ten-core functional assessment and intervention strategy Integrated medical and digital health resources Interdisciplinary collaboration to enhance elderly well-being

The HI-HOPE Project builds upon existing community-based elderly care programs, particularly the pharmaceutical care model for polypharmacy management and the osteoporosis and sarcopenia risk assessment project in Yunlin County. Using these programs as a foundation, HI-HOPE will implement clustered randomized controlled trials (RCTs) across 30 community sites in Yunlin County, targeting older adults aged 55 and above. The project will establish two groups, including HI-HOPE Integrated Care Group (10 communities) and Control Group (20 communities). The HI-HOPE group expands upon WHO's ICOPE six dimensions, adding osteoporosis, polypharmacy, urological health, and social welfare, creating a comprehensive ten-core framework. Social welfare services will integrate existing government programs such as cancer screening, digital health, and long-term care resources.

The intervention model consists of three primary components:

On-Site Community Interventions - Including exercise training, mindfulness meditation, social participation activities, oral and swallowing rehabilitation, hearing rehabilitation, and vision training.

Telehealth and Remote Education - Leveraging digital technologies for health education, monitoring, and consultations.

Referral Services - Facilitating access to medical care, transportation assistance, and follow-up support.

The project will run for two years, with biannual screenings to track changes in intrinsic capacity, core health functions, and life events, such as falls, fractures, emergency visits, hospitalizations, and mortality.

Вмешательства

  • Поведенческое Local intervention program
    HI-HOPE Project introduces a three-phase intervention program Phase 1: "Active Mind \& Body" (12 Weeks) Focus: Cognitive enhancement, depression relief, and music-based movement therapy. Delivery: Certified community instructors. Schedule: 1 session/week, 2 hours per session (total 12 sessions). Supplementary Exercise: High-intensity training by professional coaches (1 session/week, 1 hour per session). Phase 2: "Complete Senior Wellness" (12 Weeks) Focus: Comprehensive functional improvement
  • Поведенческое Referral Process
    Self-referral tracking (1-2 weeks): Participants able to visit referral sites independently will be followed up to confirm completion. Barrier assessment: If unable to attend, interviews will identify obstacles (e.g., transport, finances, willingness). Transportation support: Solutions include volunteer transport with fuel subsidies, local transport networks, and government-assisted group referrals. Financial assistance: Eligibility for social welfare aid will be assessed, with support for ap
  • Поведенческое Telehealth Education & Digital Integration
    Live-streamed health education across multiple community sites. Digital health platforms for real-time intervention monitoring and professional feedback: Polypharmacy management via medication usage tracking and pharmacist analysis. Nutritional assessment with dietitian recommendations. Health consultations provided remotely by specialists based on screening results.

Первичные конечные точки

  • Intrinsic capacity [Срок оценки: The primary outcome (intrinsic capacity) will be assessed every six months over a two-year period, totaling four evaluations throughout the study duration.]
Вторичные конечные точки (12)
  • Mini-Mental State Examination (MMSE) [Срок оценки: Every 6 months, for 2 years]
  • Brain Health Test (BHT) [Срок оценки: Every 6 months, for 2 years]
  • Geriatric Depression Scale-15 (GDS-15) [Срок оценки: Every 6 months, for 2 years]
  • Geriatric Anxiety Inventory (GAI) [Срок оценки: Every 12 months, for 2 years]
  • Chinese Happiness Inventory (CHI) [Срок оценки: Every 12 months, for 2 years]
  • Handgrip Strength [Срок оценки: Every 6 months, for 2 years]
  • Short Physical Performance Battery (SPPB) [Срок оценки: Every 6 months, for 2 years]
  • Appendicular Skeletal Muscle Index (ASMI) [Срок оценки: Every 6 months, for 2 years]
  • International Physical Activity Questionnaire (IPAQ) [Срок оценки: Every 6 months, for 2 years]
  • Mini Nutritional Assessment-Short Form (MNA-SF) [Срок оценки: Every 6 months, for 2 years]
  • Body Mass Index (BMI) [Срок оценки: Every 6 months, for 2 years]
  • Oral Frailty Assessment Scale (OF-5) [Срок оценки: Every 12 months, for 2 years]

Критерии участия

Критерии включения

  • Age ≥55 years (includes older adults and pre-elderly individuals).
  • No severe functional disability (must be able to walk independently, use assistive devices, or operate a wheelchair independently).
  • No severe cognitive impairment (must be able to respond appropriately to verbal questions).

Критерии исключения

  • Irregular community participation (less than once per week in the target community).
  • Mild dementia or greater (assessed during screening). If identified, family members will be notified, and they retain the right to withdraw the participant unconditionally.

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
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10 PMID 32033882
  • Ang S. Social participation and health over the adult life course: Does the association strengthen with age? Soc Sci Med. 2018 Jun;206:51-59. doi: 10.1016/j.socscimed.2018.03.042. Epub 2018 Apr 14. PMID 29684648
  • Blancafort Alias S, Cuevas-Lara C, Martinez-Velilla N, Zambom-Ferraresi F, Soto ME, Tavassoli N, Mathieu C, Heras Muxella E, Garibaldi P, Anglada M, Amblas J, Santaeugenia S, Contel JC, Domingo A, Salva Casanovas A. A Multi-Domain Group-Based Intervention to Promote Physical Activity, Healthy Nutrition, and Psychological Wellbeing in Older People with Losses in Intrinsic Capacity: AMICOPE Developm PMID 34199566
  • Cheng YC, Kuo YC, Chang PC, Li YC, Huang WT, Chen W, Chou CY. Geriatric Functional Impairment Using the Integrated Care for Older People (ICOPE) Approach in Community-Dwelling Elderly and Its Association with Dyslipidemia. Vasc Health Risk Manag. 2021 Jul 5;17:389-394. doi: 10.2147/VHRM.S305490. eCollection 2021. PMID 34262283
  • Rojano I Luque X, Blancafort-Alias S, Prat Casanovas S, Forne S, Martin Vergara N, Fabregat Povill P, Vila Royo M, Serrano R, Sanchez-Rodriguez D, Vilchez Saldana M, Martinez I, Dominguez Lopez M, Riba Porquet F, Intxaurrondo Gonzalez A, Salva Casanovas A. Identification of decreased intrinsic capacity: Performance of diagnostic measures of the ICOPE Screening tool in community dwelling older peop PMID 36809987
  • Chew J, Lim JP, Yew S, Yeo A, Ismail NH, Ding YY, Lim WS. Disentangling the Relationship between Frailty and Intrinsic Capacity in Healthy Community-Dwelling Older Adults: A Cluster Analysis. J Nutr Health Aging. 2021;25(9):1112-1118. doi: 10.1007/s12603-021-1679-2. PMID 34725670
  • Zhao J, Chhetri JK, Chang Y, Zheng Z, Ma L, Chan P. Intrinsic Capacity vs. Multimorbidity: A Function-Centered Construct Predicts Disability Better Than a Disease-Based Approach in a Community-Dwelling Older Population Cohort. Front Med (Lausanne). 2021 Sep 28;8:753295. doi: 10.3389/fmed.2021.753295. eCollection 2021. PMID 34651003
  • Prince MJ, Acosta D, Guerra M, Huang Y, Jacob KS, Jimenez-Velazquez IZ, Jotheeswaran AT, Llibre Rodriguez JJ, Salas A, Sosa AL, Acosta I, Mayston R, Liu Z, Llibre-Guerra JJ, Prina AM, Valhuerdi A. Intrinsic capacity and its associations with incident dependence and mortality in 10/66 Dementia Research Group studies in Latin America, India, and China: A population-based cohort study. PLoS Med. 2021 PMID 34520466

Идентификаторы

NCT: NCT06882434 · 202404065RINA

Первоисточники (государственные реестры)

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