Precision Care for Older Persons

NCT07419789 | Not Yet Recruiting

• 1 other identifier: NHRI-EX115-11506PI
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to 1) develop an Advanced Person-Centered (APC) Smart Home Care Model that is able to predict patient outcomes; and 2) evaluate the effectiveness of this model by assessing improvements in care and recovery for older individuals post hip fracture.

Conditions

Hip Fractures

Keywords

hip fracture; family caregiving; smart care; person-centered care; precision care

Outcome Measures

Primary Outcomes (48)

• Fall Incidents.

  number of falls

  1st month following discharge

• Fall Incidents.

  number of falls

  3rd month following hospital discharge

• Fall insidents

  number of falls

  6th month following hospital discharge

• Fall incidents

  Number of falls

  12th month following hospital discharge

• Fall incidents

  Number of falls

  18th month following hospital discharge

• Fall incidents

  Number of falls

  24th month following hospital discharge

• range of motion

  The clinical outcomes to be assessed include range of motion (ROM) in the affected limb in degree

  1st month following hospital discharge

• Muscle strength of affected limb

  maximum amount of force that a muscle can generate during a single contraction. The unit is weights.

  1st month following hosptial discharge

• Visual analog of Pain score

  patient self-report that collected by assessor. Score range 0-100, with higher score indicating more pain.

  1st month following hospital discharge

• Barthel Index

  assessor measures functional indepdencen in activities of daily living (ADLs) of the patient, score range 0-100, higher score indicate more independent.

  1st month following discharge

• Lawton IADL scale

  Instrumental activities of daily living (ADLs) collected by assessor. Score rage from 0 tto 8, with 8 indicating more independent function.

  1st month following discharge

• Caregiver balance

  The perception of caregivers regarding their ability to manage conflicting caregiving demands. Score range 1-3, with higher score indicating more balance.

  1st following hospital discharge

• Caregiver balance

  The perception of caregivers regarding their ability to manage conflicting caregiving demands. Score range 1-3, with higher score indicating more balance.

  3rd month following hospital discharge

• Caregiver Balance

  The perception of caregivers regarding their ability to manage conflicting caregiving demands. Score range 1-3, with higher score indicating more balance.

  6th month following hospital discharge

• Caregiver Balance

  The perception of caregivers regarding their ability to manage conflicting caregiving demands. Score range 1-3, with higher score indicating more balance.

  12th month following hospital discharge

• Caregiver Balance

  The perception of caregivers regarding their ability to manage conflicting caregiving demands. Score range 1-3, with higher score indicating more balance.

  18th month following hospital discharge

• Caregiver Balance

  The perception of caregivers regarding their ability to manage conflicting caregiving demands. Score range 1-3, with higher score indicating more balance.

  24 month following hospital discharge

• Caregiver preparedness

  Caregiver readiness to handle caregiving responsibilities and associated stresses. Score range 0-32, with higher score indicating more prepared.

  1st month following hospital discharge

• Caregiver preparedness

  Caregiver readiness to handle caregiving responsibilities and associated stresses. Score range 0-32, with higher score indicating more prepared.

  3rd month following hospital discharge

• Caregiver Preparedness

  Caregiver readiness to handle caregiving responsibilities and associated stresses. Score range 0-32, with higher score indicating more prepared.

  6th month following hospital discharge

• Caregiver Preparedness

  Caregiver readiness to handle caregiving responsibilities and associated stresses. Score range 0-32, with higher score indicating more prepared.

  12 month following hospital discharge

• Caregiver preparedness

  Caregiver readiness to handle caregiving responsibilities and associated stresses. Score range 0-32, with higher score indicating more prepared.

  18th month following hospital discharge

• range of motion

  The clinical outcomes to be assessed include range of motion (ROM) in the affected limb in degree

  3rd month following hospital discharge

• Caregiver Preparedness

  Caregiver readiness to handle caregiving responsibilities and associated stresses. Score range 0-32, with higher score indicating more prepared.

  24th month following hospital discharge

• range of motion

  The clinical outcomes to be assessed include range of motion (ROM) in the affected limb in degree

  6th month following hospital discharge

• range of motion

  The clinical outcomes to be assessed include range of motion (ROM) in the affected limb in degree

  12th month following hospital discharge

• range of motion

  The clinical outcomes to be assessed include range of motion (ROM) in the affected limb in degree

  18th month following hospital discharge

• range of motion

  The clinical outcomes to be assessed include range of motion (ROM) in the affected limb in degree

  24th month following hospital discharge

• Muscle strength of affected limb

  maximum amount of force that a muscle can generate during a single contraction. The unit is weights.

  3rd month following hosptial discharge

• Muscle strength of affected limb

  maximum amount of force that a muscle can generate during a single contraction. The unit is weights.

  6th month following hosptial discharge

• Muscle strength of affected limb

  maximum amount of force that a muscle can generate during a single contraction. The unit is weights.

  12th month following hosptial discharge

• Muscle strength of affected limb

  maximum amount of force that a muscle can generate during a single contraction. The unit is weights.

  18th month following hosptial discharge

• Muscle strength of affected limb

  maximum amount of force that a muscle can generate during a single contraction. The unit is weights.

  24th month following hosptial discharge

• Visual analog of Pain score

  patient self-report that collected by assessor. Score range 0-100, with higher score indicating more pain.

  3rd month following hospital discharge

• Visual analog of Pain score

  patient self-report that collected by assessor. Score range 0-100, with higher score indicating more pain.

  6th month following hospital discharge

• Visual analog of Pain score

  patient self-report that collected by assessor. Score range 0-100, with higher score indicating more pain.

  12th month following hospital discharge

• Visual analog of Pain score

  patient self-report that collected by assessor. Score range 0-100, with higher score indicating more pain.

  18th month following hospital discharge

• Visual analog of Pain score

  patient self-report that collected by assessor. Score range 0-100, with higher score indicating more pain.

  24th month following hospital discharge

• Barthel Index

  assessor measures functional indepdencen in activities of daily living (ADLs) of the patient, score range 0-100, higher score indicate more independent.

  3rd month following discharge

• Barthel Index

  assessor measures functional indepdencen in activities of daily living (ADLs) of the patient, score range 0-100, higher score indicate more independent.

  6th month following discharge

• Barthel Index

  assessor measures functional indepdencen in activities of daily living (ADLs) of the patient, score range 0-100, higher score indicate more independent.

  12th month following discharge

• Barthel Index

  assessor measures functional indepdencen in activities of daily living (ADLs) of the patient, score range 0-100, higher score indicate more independent.

  18 month following discharge

• Barthel Index

  assessor measures functional indepdencen in activities of daily living (ADLs) of the patient, score range 0-100, higher score indicate more independent.

  24th month following discharge

• Lawton IADL scale

  Instrumental activities of daily living (ADLs) collected by assessor. Score rage from 0 tto 8, with 8 indicating more independent function.

  3rd month following discharge

• Lawton IADL scale

  Instrumental activities of daily living (ADLs) collected by assessor. Score rage from 0 tto 8, with 8 indicating more independent function.

  6th month following discharge

• Lawton IADL scale

  Instrumental activities of daily living (ADLs) collected by assessor. Score rage from 0 tto 8, with 8 indicating more independent function.

  12 month following discharge

• Lawton IADL scale

  Instrumental activities of daily living (ADLs) collected by assessor. Score rage from 0 tto 8, with 8 indicating more independent function.

  18 month following discharge

• Lawton IADL scale

  Instrumental activities of daily living (ADLs) collected by assessor. Score rage from 0 tto 8, with 8 indicating more independent function.

  24 month following discharge

Secondary Outcomes (36)

• number of visits to emergency department

  1st month following hospital discharge

• number of hospital readmission

  1st month following hospital discharge

• Cognitive function

  1st month following hospital discharge

• Cognitive function

  3rd month following hospital discharge

• Cognitive function

  6th month following hospital discharge

Study Arms (2)

Advanced Person-Centered (APC) Smart Home Care Model

EXPERIMENTAL

Smart cloth assisted Home Care will be tailored to the needs of the individual with hip fracture and promptly administered. Continuous monitoring of clinical data will identify deviations from a patient's daily routine, which will guide ML-predictions of adverse outcomes and facilitate proactive health interventions by home nurses. Real-time feedback to caregivers will be provided via an app, providing timely alerts and ensuring swift and appropriate action.

Behavioral: Advanced Person-Centered (APC) Smart Home Care Model

Usual care

NO INTERVENTION

Routine hospital care following hip fracture surgery without smart cloth care

Interventions

Advanced Person-Centered (APC) Smart Home Care Model BEHAVIORAL

Enhanced Smart Care Model (SCM) that incorporates precise predictions of adverse outcomes and improvements in the real-time feedback system for caregivers and person-center home-based nursing.

Advanced Person-Centered (APC) Smart Home Care Model

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 60 years old,
• had been transferred from the emergency department to the hospital due to a unilateral hip fracture,
• repair of the hip fracture involved either hip arthroplasty or internal fixation, 4) their primary place of residence was northern Taiwan

You may not qualify if:

• severity of cognitive impairment (a CMMSE score of \< 10),
• known to be terminally ill,
• has no primary family caregiver,
• residing in an institutional care facility

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Chang Gung University: collaborator
• National Health Research Institutes, Taiwan: collaborator

Study Sites (2)

Tuchen Branch Chang Gung Hospital

New Taipei City, Taiwan, 106, Taiwan

Location

Linkuo Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 33302, Taiwan

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Yea-Ing Shyu

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yea-Ing Shyu, PhD

CONTACT

+886978697460; yeaing@mail.cgu.edu.tw

Jersey Liang, PhD

CONTACT

jliang@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 19, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 19, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)