- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419789
Precision Care for Older Persons
February 11, 2026 updated by: Chang Gung Memorial Hospital
Precision Care for Older Persons With Hip Fractures
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
The APC Smart Home Care Model will be developed as follows: a) incorporate a prediction system based on ML data available from our prior studies; b) incorporate an enhanced feedback system using results from the prediction system, which will allow family caregivers to receive timely alerts and facilitate interactions between home care nurses and caregivers; and c) the APC prediction system will be further developed to allow for implementation of targeted home nursing interventions that can be individualized to meet the specific needs of each family caregiver and the person recovering from hip fracture.
A mixed-methods approach will be employed to examine the effectiveness of the system, using a combination of quantitative and qualitative data.
Study Type
Interventional
Enrollment (Estimated)
218
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yea-Ing Shyu, PhD
- Phone Number: +886978697460
- Email: yeaing@mail.cgu.edu.tw
Study Contact Backup
- Name: Jersey Liang, PhD
- Email: jliang@umich.edu
Study Locations
-
-
Taiwan
-
New Taipei City, Taiwan, Taiwan, 106
- Tuchen Branch Chang Gung Hospital
-
Contact:
- Yea-Ing Shyu
- Phone Number: 0978697460
- Email: yeaing@mail.cgu.edu.tw
-
Contact:
- Chen-June Seak, MS, MD
- Email: julianseak@hotmail.com
-
Taoyuan District, Taiwan, Taiwan, 33302
- Linkuo Chang Gung Memorial Hospital
-
Contact:
- Yea-Ing Shyu, PhD
- Phone Number: 0978697460
- Email: yeaing@mail.cgu.edu.tw
-
Contact:
- Yu-Chih Lin, Master
- Email: b101092127@tmu.edu.tw
-
Sub-Investigator:
- Yu-Chih Lin, Master
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Advanced Person-Centered (APC) Smart Home Care Model
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.
|
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.
|
|
No Intervention: Usual care
Routine hospital care following hip fracture surgery without smart cloth care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fall Incidents.
Time Frame: 1st month following discharge
|
number of falls
|
1st month following discharge
|
|
Fall Incidents.
Time Frame: 3rd month following hospital discharge
|
number of falls
|
3rd month following hospital discharge
|
|
Fall insidents
Time Frame: 6th month following hospital discharge
|
number of falls
|
6th month following hospital discharge
|
|
Fall incidents
Time Frame: 12th month following hospital discharge
|
Number of falls
|
12th month following hospital discharge
|
|
Fall incidents
Time Frame: 18th month following hospital discharge
|
Number of falls
|
18th month following hospital discharge
|
|
Fall incidents
Time Frame: 24th month following hospital discharge
|
Number of falls
|
24th month following hospital discharge
|
|
range of motion
Time Frame: 1st month following hospital discharge
|
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
Time Frame: 1st month following hosptial discharge
|
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
Time Frame: 1st month following hospital discharge
|
patient self-report that collected by assessor.
Score range 0-100, with higher score indicating more pain.
|
1st month following hospital discharge
|
|
Barthel Index
Time Frame: 1st month following discharge
|
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
Time Frame: 1st month following discharge
|
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
Time Frame: 1st following hospital discharge
|
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
Time Frame: 3rd month following hospital discharge
|
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
Time Frame: 6th month following hospital discharge
|
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
Time Frame: 12th month following hospital discharge
|
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
Time Frame: 18th month following hospital discharge
|
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
Time Frame: 24 month following hospital discharge
|
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
Time Frame: 1st month following hospital discharge
|
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
Time Frame: 3rd month following hospital discharge
|
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
Time Frame: 6th month following hospital discharge
|
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
Time Frame: 12 month following hospital discharge
|
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
Time Frame: 18th month following hospital discharge
|
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
Time Frame: 3rd month following hospital discharge
|
The clinical outcomes to be assessed include range of motion (ROM) in the affected limb in degree
|
3rd month following hospital discharge
|
|
Caregiver Preparedness
Time Frame: 24th month following hospital discharge
|
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
Time Frame: 6th month following hospital discharge
|
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
Time Frame: 12th month following hospital discharge
|
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
Time Frame: 18th month following hospital discharge
|
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
Time Frame: 24th month following hospital discharge
|
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
Time Frame: 3rd month following hosptial discharge
|
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
Time Frame: 6th month following hosptial discharge
|
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
Time Frame: 12th month following hosptial discharge
|
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
Time Frame: 18th month following hosptial discharge
|
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
Time Frame: 24th month following hosptial discharge
|
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
Time Frame: 3rd month following hospital discharge
|
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
Time Frame: 6th month following hospital discharge
|
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
Time Frame: 12th month following hospital discharge
|
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
Time Frame: 18th month following hospital discharge
|
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
Time Frame: 24th month following hospital discharge
|
patient self-report that collected by assessor.
Score range 0-100, with higher score indicating more pain.
|
24th month following hospital discharge
|
|
Barthel Index
Time Frame: 3rd month following discharge
|
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
Time Frame: 6th month following discharge
|
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
Time Frame: 12th month following discharge
|
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
Time Frame: 18 month following discharge
|
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
Time Frame: 24th month following discharge
|
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
Time Frame: 3rd month following discharge
|
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
Time Frame: 6th month following discharge
|
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
Time Frame: 12 month following discharge
|
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
Time Frame: 18 month following discharge
|
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
Time Frame: 24 month following discharge
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of visits to emergency department
Time Frame: 1st month following hospital discharge
|
collected by assessor asking family members
|
1st month following hospital discharge
|
|
number of hospital readmission
Time Frame: 1st month following hospital discharge
|
collected by assessor by asking family members
|
1st month following hospital discharge
|
|
Cognitive function
Time Frame: 1st month following hospital discharge
|
Cognitive function following hip-fracture surgery will be assessed using the Taiwan version of the Mini Mental State Examination.
Score ranges 0-30, with higher score indicating better cognitive function.
|
1st month following hospital discharge
|
|
Cognitive function
Time Frame: 3rd month following hospital discharge
|
Cognitive function following hip-fracture surgery will be assessed using the Taiwan version of the Mini Mental State Examination.
Score ranges 0-30, with higher score indicating better cognitive function.
|
3rd month following hospital discharge
|
|
Cognitive function
Time Frame: 6th month following hospital discharge
|
Cognitive function following hip-fracture surgery will be assessed using the Taiwan version of the Mini Mental State Examination.
Score ranges 0-30, with higher score indicating better cognitive function.
|
6th month following hospital discharge
|
|
Cognitive function
Time Frame: 12th month following hospital discharge
|
Cognitive function following hip-fracture surgery will be assessed using the Taiwan version of the Mini Mental State Examination.
Score ranges 0-30, with higher score indicating better cognitive function.
|
12th month following hospital discharge
|
|
Cognitive function
Time Frame: 18th month following hospital discharge
|
Cognitive function following hip-fracture surgery will be assessed using the Taiwan version of the Mini Mental State Examination.
Score ranges 0-30, with higher score indicating better cognitive function.
|
18th month following hospital discharge
|
|
Cognitive function
Time Frame: 24th month following hospital discharge
|
Cognitive function following hip-fracture surgery will be assessed using the Taiwan version of the Mini Mental State Examination.
Score ranges 0-30, with higher score indicating better cognitive function.
|
24th month following hospital discharge
|
|
Depressive symptoms
Time Frame: 1st month following hospital discharge
|
Patients' depressive symptoms will be evaluated using the 15-item Geriatric Depression Scale, short form (GDS-SF).
Score range 0-15, with higher score indicating higher depressive symptoms.
|
1st month following hospital discharge
|
|
Depressive symptoms
Time Frame: 3rd month following hospital discharge
|
Patients' depressive symptoms will be evaluated using the 15-item Geriatric Depression Scale, short form (GDS-SF).
Score range 0-15, with higher score indicating higher depressive symptoms.
|
3rd month following hospital discharge
|
|
Depressive symptoms
Time Frame: 6th month following hospital discharge
|
Patients' depressive symptoms will be evaluated using the 15-item Geriatric Depression Scale, short form (GDS-SF).
Score range 0-15, with higher score indicating higher depressive symptoms.
|
6th month following hospital discharge
|
|
Depressive symptoms
Time Frame: 12th month following hospital discharge
|
Patients' depressive symptoms will be evaluated using the 15-item Geriatric Depression Scale, short form (GDS-SF).
Score range 0-15, with higher score indicating higher depressive symptoms.
|
12th month following hospital discharge
|
|
Depressive symptoms
Time Frame: 18th month following hospital discharge
|
Patients' depressive symptoms will be evaluated using the 15-item Geriatric Depression Scale, short form (GDS-SF).
Score range 0-15, with higher score indicating higher depressive symptoms.
|
18th month following hospital discharge
|
|
Depressive symptoms
Time Frame: 24th month following hospital discharge
|
Patients' depressive symptoms will be evaluated using the 15-item Geriatric Depression Scale, short form (GDS-SF).
Score range 0-15, with higher score indicating higher depressive symptoms.
|
24th month following hospital discharge
|
|
Nutritional Status
Time Frame: 1st month following hospital discharge
|
The 18-item Mini Nutritional Assessment (MNA).
Score range 0-30, with higher score indicating better nutritioanl status.
|
1st month following hospital discharge
|
|
Nutritional Status
Time Frame: 3rd month following hospital discharge
|
The 18-item Mini Nutritional Assessment (MNA).
Score range 0-30, with higher score indicating better nutritioanl status.
|
3rd month following hospital discharge
|
|
Nutritional Status
Time Frame: 6th month following hospital discharge
|
The 18-item Mini Nutritional Assessment (MNA).
Score range 0-30, with higher score indicating better nutritioanl status.
|
6th month following hospital discharge
|
|
Nutritional Status
Time Frame: 12th month following hospital discharge
|
The 18-item Mini Nutritional Assessment (MNA).
Score range 0-30, with higher score indicating better nutritioanl status.
|
12th month following hospital discharge
|
|
Nutritional Status
Time Frame: 18th month following hospital discharge
|
The 18-item Mini Nutritional Assessment (MNA).
Score range 0-30, with higher score indicating better nutritioanl status.
|
18th month following hospital discharge
|
|
Nutritional Status
Time Frame: 24th month following hospital discharge
|
The 18-item Mini Nutritional Assessment (MNA).
Score range 0-30, with higher score indicating better nutritioanl status.
|
24th month following hospital discharge
|
|
Health-Related Quality of Life (HRQoL)
Time Frame: 1st month following hospital discharge
|
Taiwan version of the 36-item Short Form Survey (SF-36).
Score range 0-100, with higher score indicating better health outcomes.
|
1st month following hospital discharge
|
|
Health-Related Quality of Life (HRQoL)
Time Frame: 3rd month following hospital discharge
|
Taiwan version of the 36-item Short Form Survey (SF-36).
Score range 0-100, with higher score indicating better health outcomes.
|
3rd month following hospital discharge
|
|
Health-Related Quality of Life (HRQoL)
Time Frame: 6th month following hospital discharge
|
Taiwan version of the 36-item Short Form Survey (SF-36).
Score range 0-100, with higher score indicating better health outcomes.
|
6th month following hospital discharge
|
|
Health-Related Quality of Life (HRQoL)
Time Frame: 12th month following hospital discharge
|
Taiwan version of the 36-item Short Form Survey (SF-36).
Score range 0-100, with higher score indicating better health outcomes.
|
12th month following hospital discharge
|
|
Health-Related Quality of Life (HRQoL)
Time Frame: 18th month following hospital discharge
|
Taiwan version of the 36-item Short Form Survey (SF-36).
Score range 0-100, with higher score indicating better health outcomes.
|
18th month following hospital discharge
|
|
Health-Related Quality of Life (HRQoL)
Time Frame: 24th month following hospital discharge
|
Taiwan version of the 36-item Short Form Survey (SF-36).
Score range 0-100, with higher score indicating better health outcomes.
|
24th month following hospital discharge
|
|
number of visits to emergency department
Time Frame: 3rd month following hospital discharge
|
collected by assessor asking family members
|
3rd month following hospital discharge
|
|
number of visits to emergency department
Time Frame: 6th month following hospital discharge
|
collected by assessor asking family members
|
6th month following hospital discharge
|
|
number of visits to emergency department
Time Frame: 12th month following hospital discharge
|
collected by assessor asking family members
|
12th month following hospital discharge
|
|
number of visits to emergency department
Time Frame: 18th month following hospital discharge
|
collected by assessor asking family members
|
18th month following hospital discharge
|
|
number of visits to emergency department
Time Frame: 24th month following hospital discharge
|
collected by assessor asking family members
|
24th month following hospital discharge
|
|
number of hospital readmission
Time Frame: 3rd month following hospital discharge
|
collected by assessor by asking family members
|
3rd month following hospital discharge
|
|
number of hospital readmission
Time Frame: 6th month following hospital discharge
|
collected by assessor by asking family members
|
6th month following hospital discharge
|
|
number of hospital readmission
Time Frame: 12 month following hospital discharge
|
collected by assessor by asking family members
|
12 month following hospital discharge
|
|
number of hospital readmission
Time Frame: 18th month following hospital discharge
|
collected by assessor by asking family members
|
18th month following hospital discharge
|
|
number of hospital readmission
Time Frame: 24 month following hospital discharge
|
collected by assessor by asking family members
|
24 month following hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yea-Ing Shyu, Chang Gung University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
February 3, 2026
First Submitted That Met QC Criteria
February 11, 2026
First Posted (Actual)
February 19, 2026
Study Record Updates
Last Update Posted (Actual)
February 19, 2026
Last Update Submitted That Met QC Criteria
February 11, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHRI-EX115-11506PI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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