Holistic Integration for Healthy Longevity and Aging in Place

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Local intervention program

    Behavioral

    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 covering all six ICOPE domains. 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 3: "Advanced Exercise Training" (12 Weeks) Focus: Strengthening self-care abilities and increasing acceptance of medical interventions. Delivery: Professional exercise coaches. Schedule: 2 sessions/week, 1 hour per session (total 24 sessions).

  • Referral Process

    Behavioral

    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 applications. Personal willingness \& health literacy: Health education will address concerns about treatment or social stigma. Telehealth consultations: Remote specialist consultations will be provided if in-person visits are not possible. Hospital-based referral support: Group hospital visits will be arranged for those with referral difficulties. Monthly tracking: Referral completion rates and outcomes will be monitored (e.g., treatments, assistive devices, social services).

  • Telehealth Education & Digital Integration

    Behavioral

    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.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 3 interventions
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intrinsic capacity

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.

Time frame
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

1

Mini-Mental State Examination (MMSE)

Score change in Mini-Mental State Examination (MMSE), range 0-30, lower score indicates higher abnormality.

Time frame
Every 6 months, for 2 years
2

Brain Health Test (BHT)

Score change in Brain Health Test (BHT), range 0-28, lower score indicates higher abnormality.

Time frame
Every 6 months, for 2 years
3

Geriatric Depression Scale-15 (GDS-15)

Score change in Geriatric Depression Scale-15 (GDS-15), range 0-15, higher score indicates more severe depressive symptoms.

Time frame
Every 6 months, for 2 years
4

Geriatric Anxiety Inventory (GAI)

Score change in Geriatric Anxiety Inventory (GAI), range 0-20, higher score indicates more severe anxiety symptoms.

Time frame
Every 12 months, for 2 years

Other outcomes

1

Ishihara Color Blindness Test

Abnormality by Ishihara Color Blindness Test (yea/no)

Time frame
Every 12 months, for 2 years
2

AMSLER Grid

AMSLER Grid, measured as presence (yes/no) of visual distortion or scotoma

Time frame
Every 12 months, for 2 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

National Taiwan University Hospital, Yun-Lin Branch

Collaborator

National Health Research Institutes, Taiwan

Collaborator

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