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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Taiwan
    • Taiwan
      • New Taipei City, Taiwan, Taiwan, 106
      • Taoyuan District, Taiwan, Taiwan, 33302
        • Linkuo Chang Gung Memorial Hospital
        • Contact:
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥ 60 years old,
  2. had been transferred from the emergency department to the hospital due to a unilateral hip fracture,
  3. repair of the hip fracture involved either hip arthroplasty or internal fixation, 4) their primary place of residence was northern Taiwan

Exclusion Criteria:

  1. severity of cognitive impairment (a CMMSE score of < 10),
  2. known to be terminally ill,
  3. has no primary family caregiver,
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Advanced Person-Centered (APC) Smart Home Care Model
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Health Research Institutes, Taiwan
Chang Gung University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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