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临床试验/NCT06882434
NCT06882434尚未招募不适用

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

National Taiwan University Hospital0 个研究点目标入组 600 人开始时间: 2025年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
600
主要终点
Intrinsic capacity

研究概览

简要总结

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.

详细描述

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.

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
None

盲法说明

This study is non-blinded, meaning both participants and researchers are aware of the assigned intervention.

入排标准

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

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Intrinsic capacity

时间窗: The primary outcome (intrinsic capacity) will be assessed every six months over a two-year period, totaling four evaluations throughout the study duration.

The primary outcome is intrinsic capacity, measured by the total number of impaired ICOPE (Integrated Care for Older People) domains (0-6). Impairment criteria are: (1) Cognitive: Mini-Mental State Examination (MMSE) \<24; (2) Depression: Geriatric Depression Scale (GDS-15) \>6; (3) Mobility: Short Physical Performance Battery (SPPB) ≤9; (4) Vitality: Mini Nutritional Assessment-Short Form (MNA-SF) ≤11; (5) Vision: ICOPE-WHO Simple Vision Test abnormal if failing distance/near vision tests or having an eye disease/chronic condition (e.g., diabetes, hypertension) without an eye exam in the past year; (6) Hearing: ICOPE Whispered Voice Test abnormal. Each domain is assessed separately and classified as either impaired (0) or not impaired (1) based on the predefined criteria. The final intrinsic capacity score is the sum of non-impaired domains (range: 0-6), with higher scores indicating greater intrinsic capacity.

次要结局

  • Mini-Mental State Examination (MMSE)(Every 6 months, for 2 years)
  • Brain Health Test (BHT)(Every 6 months, for 2 years)
  • Geriatric Anxiety Inventory (GAI)(Every 12 months, for 2 years)
  • Geriatric Depression Scale-15 (GDS-15)(Every 6 months, for 2 years)
  • Chinese Happiness Inventory (CHI)(Every 12 months, for 2 years)
  • Handgrip Strength(Every 6 months, for 2 years)
  • Short Physical Performance Battery (SPPB)(Every 6 months, for 2 years)
  • Appendicular Skeletal Muscle Index (ASMI)(Every 6 months, for 2 years)
  • International Physical Activity Questionnaire (IPAQ)(Every 6 months, for 2 years)
  • Mini Nutritional Assessment-Short Form (MNA-SF)(Every 6 months, for 2 years)
  • Body Mass Index (BMI)(Every 6 months, for 2 years)
  • Oral Frailty Assessment Scale (OF-5)(Every 12 months, for 2 years)
  • Community Periodontal Index (CPI) score(Every 12 months, for 2 years)
  • Loss of Attachment (LA) code(Every 12 months, for 2 years)
  • Decayed, Missing, and Filled Teeth (DMFT)(Every 12 months, for 2 years)
  • Tongue base ultrasonography(Every 12 months, for 2 years)
  • Hearing Handicap Inventory for the Elderly - Short Form, Chinese version (HHIE-C)(Every 12 months, for 2 years)
  • International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF)(Every 12 months, for 2 years)
  • EuroQol-5 Dimension 5-Level (EQ-5D-5L)(Every 6 months, for 2 years)
  • Barthel Index (for activities of daily living)(Every 6 months, for 2 years)
  • Instrumental Activities of Daily Living (IADL)(Every 6 months, for 2 years)
  • Health Events(Every 3 months, for 2 years)
  • Fracture Risk Assessment Tool (FRAX)(Before the intervention (baseline) and at 24th month)
  • Bone Mineral Density (BMD)(Before the intervention (baseline) and at 24th month)
  • Polypharmacy(Every 6 months, for 2 years)
  • Anticholinergic burden (ACB)(Every 6 months, for 2 years)
  • Potentially Inappropriate Medications (PIMs)(Every 6 months, for 2 years)
  • ARMS (Adherence to Refills and Medications Scale)(Every 6 months, for 2 years)
  • Number of drugs with fall risk(Every 6 months, for 2 years)
  • Number of drug-related problems (DRPs)(Every 6 months, for 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Clinical Trial Center

Superintendent, National Taiwan Univerisity Hospital Yunlin Branch

National Taiwan University Hospital

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