Limb InjuryNCT06902636
Geriatric Trauma Care Program for Living Alone Older Adults With Injuries
A study testing Geriatric trauma care program in people with Limb Injury and Older Adults, run by Kaohsiung Medical University at 1 site in Taiwan.
Trial summary
To examine the long-term effects of the Geriatric Trauma Care Program (GTCP) regarding pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Limb Injury, Older Adults, Geriatric
- What is being tested?
- Geriatric trauma care program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Mar 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- with an ISS greater than 16 (severe injuries)
- having cognitive impairments
- diagnosed with psychiatric illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, Kaohsiung, 807
About this study
Official title: 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
To examine the long-term effects of the Geriatric Trauma Care Program (GTCP) regarding pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone.
Read the 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.
- Conditions
- Limb Injury, Older Adults, Geriatric, Pain, Geriatric Depression, Barthel Index
- Being tested
- Geriatric trauma care program
- Keywords
- Limb injury, geriatric trauma, older adults, loneliness
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric trauma care programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will have the routine care only |
| Geriatric Trauma Care Program | Experimental | 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. Receives: Behavioral: Geriatric trauma care program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured by the Numeric Pain Rating Scale with the numbers 0-10, with 0 meaning no pain and 10 meaning the worst pain.
Measured: Day 1 at Hospital discharge, 1 month, and 3 months
Functional disability
The Barthel's Index consists of 30 items, ranging from 0 to 100, with higher scores indicating greater functional capacity.
Measured: Day 1 at Hospital discharge, 1 month, and 3 months
Depression
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.
Measured: Day 1 at Hospital discharge, 1 month, and 3 months
Loneliness
The Elderly Loneliness Scale has eight items, with a higher score indicating more loneliness.
Measured: Day 1 at Hospital discharge, 1 month, and 3 months
Health-related quality of life
The EuroQol-5D has five items with higher score indicated a worse health condition.
Measured: Day 1 at Hospital discharge, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start27 Mar 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, two-arm experimental design will be used.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Santo Imanuel Tonapa, Kaohsiung Medical University
- Investigators
- Bih-O Lee, PhD, Principal investigator, College of Nursing, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902636
- Sponsor's protocol ID
- KMUHIRB-F(I)-20230043
- Other IDs
- NSTC113-2314-B-037-050-MY2-1
- Status last verified
- Aug 2026
- First submitted
- 21 Mar 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06902636
- Acronym / sponsor ID
- KMUHIRB-F(I)-20230043
- Conditions
- Limb Injury, Older Adults, Geriatric, Pain, Geriatric Depression, Barthel Index
- Keywords
- Limb injury, geriatric trauma, older adults, loneliness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine the long-term effects of the Geriatric Trauma Care Program (GTCP) regarding pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized, double-blind, two-arm experimental design will be used.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will have the routine care only |
| Geriatric Trauma Care Program | Experimental | Behavioral: Geriatric trauma care programThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- with an ISS greater than 16 (severe injuries)
- having cognitive impairments
- diagnosed with psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric trauma care programThe 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. | Behavioural | Geriatric Trauma Care Program |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bih-O Lee, PhD principal investigator
College of Nursing, Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric trauma care program in people with Limb Injury and Older Adults, run by Kaohsiung Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bih-O Lee, PhD (07-3121101 ext. 2625, biholee@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Day 1 at Hospital discharge, 1 month, and 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.