- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06902636
Geriatric Trauma Care Program for Living Alone Older Adults With Injuries
Patient Experience of Older Adults Living Alone With Injuries and Long-Term Effects of Geriatric Trauma Care Program for Living Alone Older Adults With Injuries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Traumatic injuries among older adults represent a significant public health concern due to their potential to severely affect individuals' long-term physical, emotional, and social well-being. Older adults who experience traumatic injuries often face substantial challenges during recovery, particularly those living alone who may lack sufficient support systems, exacerbating their vulnerability to chronic health issues. Pain, functional disability, depression, loneliness, and diminished health-related quality of life are prevalent adverse outcomes following traumatic injuries, underscoring the critical need for effective, targeted care strategies to address these multidimensional impacts.
The Geriatric Trauma Care Program (GTCP) is a nurse practitioner-led, digitalized trauma care program designed to provide comprehensive and accessible intervention aimed at improving immediate trauma care outcomes and facilitating sustainable recovery among older adults. While short-term benefits of digitally supported, geriatric-focused trauma interventions have been documented, the long-term effectiveness of such programs, especially for older individuals who live alone, remains less understood. Consequently, examining the enduring impact of the GTCP is essential to determine its effectiveness in fostering sustained recovery and improving quality of life for this vulnerable population. This study aims to address this gap by evaluating the long-term effects of the GTCP on pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone. Findings from this research will provide valuable insights for healthcare providers and policymakers to enhance care delivery models, optimize resource allocation, and ultimately improve long-term outcomes for older adults recovering from traumatic injuries.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bih-O Lee, PhD
- Phone Number: 2625 07-3121101
- Email: biholee@kmu.edu.tw
Study Contact Backup
- Name: Santo Imanuel Tonapa, PhD
- Phone Number: 0981979212
- Email: i.santonapa@gmail.com
Study Locations
-
-
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Kaohsiung, Taiwan, 807
- Recruiting
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- willing to join this study for three months
- with limb injuries
- living alone in a household
- aged 65 years old or older
- independent before a traumatic injury
- having a smartphone.
Exclusion Criteria:
- with an ISS greater than 16 (severe injuries)
- having cognitive impairments
- diagnosed with psychiatric illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
The control group will have the routine care only
|
|
|
Experimental: Geriatric Trauma Care Program
The experiment group will implement the Geriatric Trauma Care Program (GTCP) and routine care.
The GTCP will be implemented through an E-book that includes six units of intervention for older adults with traumatic injuries who live alone.
|
The experiment group will implement the Geriatric trauma care program (GTCP) and routine care.
The GTCP will be implemented by a nurse practitioner and equipped with digitalized educational material, including six units of intervention for older adults with traumatic injuries who live alone.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Day 1 at Hospital discharge, 1 month, and 3 months
|
Measured by the Numeric Pain Rating Scale with the numbers 0-10, with 0 meaning no pain and 10 meaning the worst pain.
|
Day 1 at Hospital discharge, 1 month, and 3 months
|
|
Functional disability
Time Frame: Day 1 at Hospital discharge, 1 month, and 3 months
|
The Barthel's Index consists of 30 items, ranging from 0 to 100, with higher scores indicating greater functional capacity.
|
Day 1 at Hospital discharge, 1 month, and 3 months
|
|
Depression
Time Frame: Day 1 at Hospital discharge, 1 month, and 3 months
|
The Geriatric Depression Scale Short Form, which comprises 15 items scored on a two-point scale (0 = no, 1 = yes).
It scores ranged from 0-15 with the higher indicated the more severe depression symptoms.
|
Day 1 at Hospital discharge, 1 month, and 3 months
|
|
Loneliness
Time Frame: Day 1 at Hospital discharge, 1 month, and 3 months
|
The Elderly Loneliness Scale has eight items, with a higher score indicating more loneliness.
|
Day 1 at Hospital discharge, 1 month, and 3 months
|
|
Health-related quality of life
Time Frame: Day 1 at Hospital discharge, 1 month, and 3 months
|
The EuroQol-5D has five items with higher score indicated a worse health condition.
|
Day 1 at Hospital discharge, 1 month, and 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bih-O Lee, PhD, College of Nursing, Kaohsiung Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-F(I)-20230043
- NSTC113-2314-B-037-050-MY2-1 (Other Grant/Funding Number: National Science and Technology Council of Taiwan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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