Clinical trial NCT06882434: Holistic Integration for Healthy Longevity and Aging in Place
Official title: Holistic Integration for Healthy Longevity and Aging in Place - Establishing Full-spectrum Community-based Care System for Older People to Maintain Wellbeing Pursuing Abilities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Decline
Sarcopenia
Depression Disorders
Nutrition Disorder
Swallowing Difficulties
Hearing Disorder
Visual Disorder
Osteoporosis
Urologic Disorders
Polypharmacy
Keywords: HIHOPE
I-COPE
dementia
depression
dysphagia
nutrition
sarcopenia
frailty
hearing disorder
visual disorder
osteoporosis
urologic disorder
polypharmacy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
name: National Health Research Institutes, Taiwan
First posted: 2025-03-18
Enrollment: 600
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study adopts a clustered randomized controlled trial (cRCT) design, where 30 community sites are randomly assigned into two groups: intervention group and control group, with a 1:2 community allocation ratio.

To ensure balanced distribution, the randomization process involves two stratification steps:

Community Size Stratification: Communities are first grouped based on size (≥20 participants vs. \<20 participants).

Urban-Rural Stratification: Communities are further stratified based on their urban or rural development status.

Within each stratum, communities are randomly allocated to the intervention or control group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intrinsic capacity
timeFrame: The primary outcome (intrinsic capacity) will be assessed every six months over a two-year period, totaling four evaluations throughout the study duration.
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Every 6 months, for 2 years
measure: Brain Health Test (BHT)
timeFrame: Every 6 months, for 2 years
measure: Geriatric Depression Scale-15 (GDS-15)
timeFrame: Every 6 months, for 2 years
measure: Geriatric Anxiety Inventory (GAI)
timeFrame: Every 12 months, for 2 years
measure: Chinese Happiness Inventory (CHI)
timeFrame: Every 12 months, for 2 years
measure: Handgrip Strength
timeFrame: Every 6 months, for 2 years
measure: Short Physical Performance Battery (SPPB)
timeFrame: Every 6 months, for 2 years
measure: Appendicular Skeletal Muscle Index (ASMI)
timeFrame: Every 6 months, for 2 years
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Every 6 months, for 2 years
measure: Mini Nutritional Assessment-Short Form (MNA-SF)
timeFrame: Every 6 months, for 2 years
measure: Body Mass Index (BMI)
timeFrame: Every 6 months, for 2 years
measure: Oral Frailty Assessment Scale (OF-5)
timeFrame: Every 12 months, for 2 years
measure: Community Periodontal Index (CPI) score
timeFrame: Every 12 months, for 2 years
measure: Loss of Attachment (LA) code
timeFrame: Every 12 months, for 2 years
measure: Decayed, Missing, and Filled Teeth (DMFT)
timeFrame: Every 12 months, for 2 years
measure: Tongue base ultrasonography
timeFrame: Every 12 months, for 2 years
measure: Hearing Handicap Inventory for the Elderly - Short Form, Chinese version (HHIE-C)
timeFrame: Every 12 months, for 2 years
measure: International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI-SF)
timeFrame: Every 12 months, for 2 years
measure: EuroQol-5 Dimension 5-Level (EQ-5D-5L)
timeFrame: Every 6 months, for 2 years
measure: Barthel Index (for activities of daily living)
timeFrame: Every 6 months, for 2 years
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Every 6 months, for 2 years
measure: Health Events
timeFrame: Every 3 months, for 2 years
measure: Fracture Risk Assessment Tool (FRAX)
timeFrame: Before the intervention (baseline) and at 24th month
measure: Bone Mineral Density (BMD)
timeFrame: Before the intervention (baseline) and at 24th month
measure: Polypharmacy
timeFrame: Every 6 months, for 2 years
measure: Anticholinergic burden (ACB)
timeFrame: Every 6 months, for 2 years
measure: Potentially Inappropriate Medications (PIMs)
timeFrame: Every 6 months, for 2 years
measure: Number of drugs with fall risk
timeFrame: Every 6 months, for 2 years
measure: Number of drug-related problems (DRPs)
timeFrame: Every 6 months, for 2 years
measure: ARMS (Adherence to Refills and Medications Scale)
timeFrame: Every 6 months, for 2 years
Other outcomes:
measure: Ishihara Color Blindness Test
timeFrame: Every 12 months, for 2 years
measure: AMSLER Grid
timeFrame: Every 12 months, for 2 years
Locations:
Study officials:
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