Holistic Integration for Healthy Longevity and Aging in Place

NCT06882434 | Not Yet Recruiting

• 1 other identifier: 202404065RINA
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

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.

  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 (30)

• Mini-Mental State Examination (MMSE)

  Every 6 months, for 2 years

• Brain Health Test (BHT)

  Every 6 months, for 2 years

• Geriatric Depression Scale-15 (GDS-15)

  Every 6 months, for 2 years

• Geriatric Anxiety Inventory (GAI)

  Every 12 months, for 2 years

• Chinese Happiness Inventory (CHI)

  Every 12 months, for 2 years

Other Outcomes (2)

• Ishihara Color Blindness Test

  Every 12 months, for 2 years

• AMSLER Grid

  Every 12 months, for 2 years

Study Arms (2)

Intervention

EXPERIMENTAL

The HI-HOPE Project implements a three-phase intervention over 48 weeks, integrating cognitive, physical, and social engagement strategies. Phase 1 (12 Weeks): Focuses on cognitive stimulation, depression relief, and music-based movement therapy. Includes weekly high-intensity exercise (3 hours/week). Phase 2 (12 Weeks): Covers all six ICOPE domains with community-led wellness sessions and weekly high-intensity exercise (3 hours/week). Phase 3 (12 Weeks): Intensive strength and mobility training (2 hours/week). Referral Process: Individuals with abnormal screenings receive personalized support, including transportation aid, financial assistance, telehealth, and group referrals. Digital Health: Uses telehealth consultations, medication tracking, and nutritional assessments to enhance care access and monitor intervention outcomes.

Behavioral: Local intervention program; Behavioral: Referral Process; Behavioral: Telehealth Education & Digital Integration

Control

NO INTERVENTION

Participants in the control group will undergo the same baseline and follow-up assessments as the intervention group. After evaluation, they will be informed of any abnormal findings and provided with recommendations for appropriate medical referrals based on standard care practices. However, no additional referral assistance, intervention programs, or follow-up services will be provided beyond the basic healthcare guidance currently available in the community.

Interventions

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).

Intervention

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).

Intervention

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.

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Taiwan University Hospital, Yun-Lin Branch: collaborator
• National Health Research Institutes, Taiwan: collaborator

Related Publications (12)

• 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: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 BACKGROUND

• 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 BACKGROUND

• 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 Development Study. Int J Environ Res Public Health. 2021 Jun 2;18(11):5979. doi: 10.3390/ijerph18115979.

  PMID: 34199566 BACKGROUND

• 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 BACKGROUND

• 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 people in the VIMCI study. BMC Geriatr. 2023 Feb 21;23(1):106. doi: 10.1186/s12877-023-03799-0.

  PMID: 36809987 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Sep 14;18(9):e1003097. doi: 10.1371/journal.pmed.1003097. eCollection 2021 Sep.

  PMID: 34520466 BACKGROUND

• Gonzalez-Bautista E, de Souto Barreto P, Andrieu S, Rolland Y, Vellas B; MAPT/DSA group (members are listed under 'Contributors'). Screening for intrinsic capacity impairments as markers of increased risk of frailty and disability in the context of integrated care for older people: Secondary analysis of MAPT. Maturitas. 2021 Aug;150:1-6. doi: 10.1016/j.maturitas.2021.05.011. Epub 2021 Jun 4.

  PMID: 34274071 BACKGROUND

• Lu F, Li J, Liu X, Liu S, Sun X, Wang X. Diagnostic performance analysis of the Integrated Care for Older People (ICOPE) screening tool for identifying decline in intrinsic capacity. BMC Geriatr. 2023 Aug 23;23(1):509. doi: 10.1186/s12877-023-04180-x.

  PMID: 37612657 BACKGROUND

• Leung AYM, Su JJ, Lee ESH, Fung JTS, Molassiotis A. Intrinsic capacity of older people in the community using WHO Integrated Care for Older People (ICOPE) framework: a cross-sectional study. BMC Geriatr. 2022 Apr 8;22(1):304. doi: 10.1186/s12877-022-02980-1.

  PMID: 35395736 BACKGROUND

• Chang KC, Hung SH, Hsueh SJ, Chao SF, Huang WL, Chen HS, Jeng Y, Chen HH, Hwang JJ, Liou HH. Development of the Houston-Apollo model for older people living in remote areas in Taiwan. Geriatr Gerontol Int. 2021 Mar;21(3):299-305. doi: 10.1111/ggi.14130. Epub 2021 Feb 1.

  PMID: 33527540 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Sarcopenia; Nutrition Disorders; Deglutition Disorders; Hearing Disorders; Vision Disorders; Osteoporosis; Urologic Diseases; Dementia; Depression; Frailty

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutritional and Metabolic Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Eye Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Behavioral Symptoms; Behavior; Pathologic Processes

Central Study Contacts

Kai-Chieh Chang, MD

CONTACT

+886930220332; b94401022@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is non-blinded, meaning both participants and researchers are aware of the assigned intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Superintendent, National Taiwan Univerisity Hospital Yunlin Branch

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share