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AI Assessment and Prediction Models for Geriatric Trauma

Primary Purpose

Trauma, Aging

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Health service program
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Trauma

Eligibility Criteria

65 Years - 74 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • admitted to the hospital due to injury first time
  • able to communicate in Mandarin
  • agree to participate in this study from hospital discharge to one month after hospital discharge
  • patients and their primary caregivers have smart mobile phones and internet access available
  • can move independently before trauma

Exclusion Criteria:

  • not frequent user for smart phones
  • severe cognitive impairment
  • victims of hangings and poisonings

Sites / Locations

  • Kaohsiung Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Contrast group

Arm Description

Researchers will conduct the health service program for the experimental group.

The contrast group will be receiving the routine care only.

Outcomes

Primary Outcome Measures

The Numeric Pain Rating Scale
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.
The Numeric Pain Rating Scale
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.
The Geriatric Depression Scale Short Form
The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.
The World Health Organization Quality of Life Questionnaire
The WHOQoOL-BREF will be used to measure quality of life. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQoL-BREF. The WHOQoL-BREF is a 26-item scale that is measure along with four subscales including physical, psychological, social relationship and environment domains. Scores range from 1 to 5 with higher scores indicating higher quality of life. The reliability and validity of the Chinese WHOQoL-BREF have been tested in patients with traumatic injuries, but not in geriatric trauma. Thus, the Cronbach's alpha for this study will be retested.
The Berg Balance Scale
The BBS is a 14-item scale used to assess balance of the older adult in various clinical settings. Each item of the BBS is scored from 0 to 4, which are added to make a total score from 0 to 56; a higher score indicates better balance.
The key body points that match the items in the Berg Balance Scale
Although the BBS has been widely used and has good psychometric properties, the scale has its limitation in detecting detailed change of balance in older adults. Neuls et al. suggested that clinicians could use the BBS combined with other measures considering unique patient factors to quantify the chances of older adults. Therefore, the key points for 17 human parts and body joints matching the 14 items of the BBS will be recorded as images. Video captured by front and side cameras will be made by each item with 5 levels. Because of page limits, we present 7 items to demonstrate how those key points compared to BBS items captured by cameras.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2021
Last Updated
December 9, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05176054
Brief Title
AI Assessment and Prediction Models for Geriatric Trauma
Official Title
Establishing AI Assessment and Prediction Models for Geriatric Trauma and Effects of AI Incorporated Into an Innovative Health Service Program in Geriatric Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To fill up the research gaps and build up a healthcare service model for geriatric trauma patients, this two-stage study aims to (a) develop geriatric trauma Artificial Intelligence (AI) prediction models by comparing the outcomes from clinical assessment and AI joint images; and (b) examine the long-term effects of an innovative health service program in geriatric trauma patients.
Detailed Description
Background: About 40% trauma patients will be over age 65 years by 2050, thus geriatric trauma constitutes an increasingly recognized problem that should be concerned. However, little is known about complicated causes of injury and long-term outcomes in older injured patients. Previous study strategies to promote health outcomes for geriatric trauma still are inconclusive. Due to the limited healthcare resources and workforce, health service for geriatric trauma care should be refined in the new era. Expected outcomes/impacts: This study attempts to build up a modern healthcare model that may influence geriatric trauma care as well geriatric assessment. The AI prediction model can be used to quickly assess "degree of balance" for geriatric trauma patients. This study will involve a nursing student and healthcare professionals, and help them to learn how AI connects to geriatric trauma care. This would be an opportunity to cultivate potential experts for AI and healthcare. Last, the outcomes are highly associated with the government's policies related to smart health, smart healthcare, and long-term care workforce.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Aging

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
418 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Researchers will conduct the health service program for the experimental group.
Arm Title
Contrast group
Arm Type
No Intervention
Arm Description
The contrast group will be receiving the routine care only.
Intervention Type
Other
Intervention Name(s)
Health service program
Intervention Description
The program will be implemented into the experimental group, the program has been designed as a three-stage model including hospital management, transition care, and post-acute stage care.
Primary Outcome Measure Information:
Title
The Numeric Pain Rating Scale
Description
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.
Time Frame
at 1 day before hospital discharge
Title
The Numeric Pain Rating Scale
Description
The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. No further reliability and validity tests are needed.
Time Frame
at 1 months after hospital discharge
Title
The Geriatric Depression Scale Short Form
Description
The GDS-SF is a 15-item scale used to identify depression in older adults. It is from the original GDS developed by Sheikh and Yesavage to examine the self-perceived emotions of older adults. The version will be used in this study is a validated Chinese that has been tested its reliability in geriatric older population in Taiwan. The GDS-SF features binary scores for a total score of 0-15. A higher score indicates a more severe of depression. In the GDS-SF, a score of 0 to 5 is normal, a score > 5 suggests depression, and a score ≥ 10 is almost indicative of depression. The Cronbach's alpha for this study will be retested.
Time Frame
at 1 months after hospital discharge
Title
The World Health Organization Quality of Life Questionnaire
Description
The WHOQoOL-BREF will be used to measure quality of life. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQoL-BREF. The WHOQoL-BREF is a 26-item scale that is measure along with four subscales including physical, psychological, social relationship and environment domains. Scores range from 1 to 5 with higher scores indicating higher quality of life. The reliability and validity of the Chinese WHOQoL-BREF have been tested in patients with traumatic injuries, but not in geriatric trauma. Thus, the Cronbach's alpha for this study will be retested.
Time Frame
at 1 months after hospital discharge
Title
The Berg Balance Scale
Description
The BBS is a 14-item scale used to assess balance of the older adult in various clinical settings. Each item of the BBS is scored from 0 to 4, which are added to make a total score from 0 to 56; a higher score indicates better balance.
Time Frame
at 1 months after hospital discharge
Title
The key body points that match the items in the Berg Balance Scale
Description
Although the BBS has been widely used and has good psychometric properties, the scale has its limitation in detecting detailed change of balance in older adults. Neuls et al. suggested that clinicians could use the BBS combined with other measures considering unique patient factors to quantify the chances of older adults. Therefore, the key points for 17 human parts and body joints matching the 14 items of the BBS will be recorded as images. Video captured by front and side cameras will be made by each item with 5 levels. Because of page limits, we present 7 items to demonstrate how those key points compared to BBS items captured by cameras.
Time Frame
at 1 months after hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: admitted to the hospital due to injury first time able to communicate in Mandarin agree to participate in this study from hospital discharge to one month after hospital discharge patients and their primary caregivers have smart mobile phones and internet access available can move independently before trauma Exclusion Criteria: not frequent user for smart phones severe cognitive impairment victims of hangings and poisonings
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bih-O Lee, PHD
Phone
886-7-312-1101
Ext
2625
Email
biholee@kmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bih-O Lee, PHD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University
City
Kaohsiung City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bih-O Lee, PHD
Phone
886-7-312-1101
Ext
2625
Email
biholee@kmu.edu.tw

12. IPD Sharing Statement

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AI Assessment and Prediction Models for Geriatric Trauma

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